Placebos
Administration of vaporized cannabis plus either dronabinol or placebo pill
sugar pillLoading study record…
Loading study record…
This study will involve treating low back pain associated with nerve injury with oral delta-9-tetrahydrocannabinol (Δ9-THC) or whole plant cannabis for eight weeks. Research subjects will consume either oral Δ9-THC (dronabinol), vaporized 3.7% Δ9-THC/5.6% CBD, or placebo. An analysis will then be determined to assess the risk--benefit ratio of dronabinol and vaporized 3.7% Δ9-THC/5.6% CBD .
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-09-28
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
The present study is designed to assess whether treatment with vaporized cannabis or dronabinol (oral Δ9-THC) reduces spontaneous and evoked pain more than placebo, and whether there are any differences between the two active treatments in terms of interference with activities of daily living. This study also aims to examine the effects of vaporized whole plant cannabis and dronabinol on mood, neuropsychological function, and psychomimetic side-effects (high, stoned, etc.) compared to placebo and to each other. In addition, we plan to examine the acute effects (after receiving stable treatment for 4 weeks) of vaporized cannabis and dronabinol compared to placebo and each other on driving skills.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Administration of vaporized cannabis plus either dronabinol or placebo pill
sugar pillAdministration of vaporized cannabis plus either dronabinol or placebo pill
MarinolAdministration of vaporized cannabis plus either dronabinol or placebo pill
marijuanaSource-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
The primary outcome is self-reported daily average numerical pain intensity during the past 24 hours. The numerical pain intensity is an 11-point pain intensity numerical rating scale (PI-NRS), where 0 equals no pain and 10 equals worst possible pain. The time frame includes baseline and weeks 1, 3, 5, 7, 8. Baseline is the pain tensity reported at the first day in the daily diary, before the first dose. The follow-up pain intensities (weeks 1, 3, 5, 7, 8) are the daily diary average pain intensities since the previously reported timepoint.
Population: There are missing values.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 39 | 6.03 | 1.65 |
| Dronabinol | 37 | 6.11 | 1.65 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 41 | 6.24 | 1.87 |
| Placebos | 39 | 5.97 | 2.01 |
| Dronabinol | 37 | 5.80 | 1.62 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 41 | 5.64 | 1.98 |
| Placebos | 39 | 5.65 | 1.56 |
| Dronabinol | 37 | 5.67 | 1.62 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 41 | 5.43 | 2.11 |
| Placebos | 39 | 5.47 | 1.77 |
Eligibility
primary outcomes
Time frame: 8 weeks
The primary outcome is self-reported daily average numerical pain intensity during the past 24 hours. The numerical pain intensity is an 11-point pain intensity numerical rating scale (PI-NRS), where 0 equals no pain and 10 equals worst possible pain. The time frame includes baseline and weeks 1, 3, 5, 7, 8. Baseline is the pain tensity reported at the first day in the daily diary, before the first dose. The follow-up pain intensities (weeks 1, 3, 5, 7, 8) are the daily diary average pain intensities since the previously reported timepoint.
secondary outcomes
Time frame: 8 weeks
A Task Force was convened by the NIH Pain Consortium, with the goal of developing research standards for chronic low back pain. The results included recommendations for a repeated measures dataset in order to establish greater consistency in reporting in order to facilitate comparisons among studies. The repeated measure minimal dataset is based upon scores based upon the Patient-Reported Outcomes Measurement Information System ® (PROMIS). These items yield a classification of impacts on the lives of patients that range from 1 (least impact) to 42 (greatest impact).
Time frame: 8 weeks
The Neuropathic Pain Scale (NPS) is an 11-point numerical scale consisting of 13 questions that ask ratings of various pain descriptors (including pain intensity, sharpness, burning, aching, cold, sensitivity, itching,unpleasantness, deep, and surface pain). The NPS is scored as the sum of these pain descriptors. Range of scores is from 0 to100. A higher score is a worse score.
Time frame: 8 weeks
The Hopkins Verbal Learning Test provides information on the ability to learn and immediately recall verbal information across trials, as well at the ability to retain, reproduce, and recognize this information after a delay. A list of 12 words is presented to the subject over three trials. After each trial, the subject is to recall as many items as possible from the list in any desired order. A 20-minute delay follows the administration of the three trials, after which the subject is asked to recall the list. The ability to learn is represented by the number of correct words, with a score range of 0-36. A higher score indicates better performance.
Time frame: 8 weeks
The Grooved Pegboard Test is a test of fine motor coordination and speed. Subjects are required to place 25 small metal pegs into holes on a 3" x 3" metal board. All pegs are alike and have a ridge on one side, which corresponds to a notch in each hole on the board. First the dominant hand is tested, and subjects are asked to place the pegs in the holes as fast as they can. This is then repeated with the non-dominant hand, and the total time for each hand is recorded. A higher score indicates worse performance.
Publications
No exact PMID-linked public article is currently readable locally.
| Dronabinol | 37 | 4.89 | 1.88 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 41 | 4.82 | 2.29 |
| Placebos | 39 | 5.26 | 1.80 |
| Dronabinol | 37 | 4.35 | 2.02 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 41 | 4.72 | 2.23 |
| Placebos | 39 | 5.22 | 1.92 |
| Dronabinol | 37 | 4.19 | 2.02 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 41 | 4.45 | 2.11 |
A Task Force was convened by the NIH Pain Consortium, with the goal of developing research standards for chronic low back pain. The results included recommendations for a repeated measures dataset in order to establish greater consistency in reporting in order to facilitate comparisons among studies. The repeated measure minimal dataset is based upon scores based upon the Patient-Reported Outcomes Measurement Information System ® (PROMIS). These items yield a classification of impacts on the lives of patients that range from 1 (least impact) to 42 (greatest impact).
Population: There were some missing data
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 44 | 21.6 | 7.29 |
| Dronabinol | 42 | 22.5 | 6.46 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 23.1 | 7.03 |
| Placebos | 44 | 18.5 | 8.97 |
| Dronabinol | 42 | 19.9 | 6.48 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 20.3 | 8.08 |
| Placebos | 44 | 17.2 | 7.40 |
| Dronabinol | 42 | 18.1 | 7.44 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 19.2 | 9.30 |
| Placebos | 44 | 16.3 | 7.70 |
| Dronabinol | 42 | 16.9 | 6.93 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 16.6 | 9.18 |
| Placebos | 44 | 16.2 | 7.42 |
| Dronabinol | 42 | 15.1 | 7.17 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 16.1 | 9.88 |
| Placebos | 44 | 15.9 | 9.06 |
| Dronabinol | 42 | 15.8 | 8.53 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 15.8 | 10.3 |
The Neuropathic Pain Scale (NPS) is an 11-point numerical scale consisting of 13 questions that ask ratings of various pain descriptors (including pain intensity, sharpness, burning, aching, cold, sensitivity, itching,unpleasantness, deep, and surface pain). The NPS is scored as the sum of these pain descriptors. Range of scores is from 0 to100. A higher score is a worse score.
Population: Some subjects dropped out before completing the study.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 44 | 45.9 | 15.2 |
| Dronabinol | 43 | 45.1 | 13.5 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 48.3 | 15.7 |
| Placebos | 44 | 40.4 | 16.7 |
| Dronabinol | 43 | 38.9 | 12.0 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 42.3 | 15.9 |
| Placebos | 44 | 37.0 | 17.2 |
| Dronabinol | 43 | 34.6 | 13.6 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 39.2 | 19.1 |
| Placebos | 44 | 35.1 | 16.4 |
| Dronabinol | 43 | 30.8 | 14.8 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 37.5 | 17.6 |
| Placebos | 44 | 36.0 | 17.8 |
| Dronabinol | 43 | 29.6 | 14.8 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 33.4 | 19.7 |
| Placebos | 44 | 34.6 | 18.3 |
| Dronabinol | 43 | 28.2 | 16.3 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 33.2 | 20.4 |
The Hopkins Verbal Learning Test provides information on the ability to learn and immediately recall verbal information across trials, as well at the ability to retain, reproduce, and recognize this information after a delay. A list of 12 words is presented to the subject over three trials. After each trial, the subject is to recall as many items as possible from the list in any desired order. A 20-minute delay follows the administration of the three trials, after which the subject is asked to recall the list. The ability to learn is represented by the number of correct words, with a score range of 0-36. A higher score indicates better performance.
Population: Some subjects dropped out before completing the study.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 44 | 24.1 | 5.24 |
| Dronabinol | 42 | 23.7 | 5.21 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 24.4 | 4.90 |
| Placebos | 44 | 24.0 | 4.78 |
| Dronabinol | 42 | 23.3 | 4.44 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 24.0 | 4.44 |
| Placebos | 44 | 22.9 | 3.74 |
| Dronabinol | 42 | 23.6 | 5.04 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 22.8 | 4.08 |
| Placebos | 44 | 25.6 | 3.84 |
| Dronabinol | 42 | 24.0 | 4.90 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 24.6 | 4.55 |
| Placebos | 44 | 24.3 | 4.00 |
| Dronabinol | 42 | 24.7 | 4.78 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 23.8 | 4.99 |
| Placebos | 44 | 24.0 | 4.16 |
| Dronabinol | 42 | 24.5 | 4.68 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 24.8 | 5.53 |
The Grooved Pegboard Test is a test of fine motor coordination and speed. Subjects are required to place 25 small metal pegs into holes on a 3" x 3" metal board. All pegs are alike and have a ridge on one side, which corresponds to a notch in each hole on the board. First the dominant hand is tested, and subjects are asked to place the pegs in the holes as fast as they can. This is then repeated with the non-dominant hand, and the total time for each hand is recorded. A higher score indicates worse performance.
Population: There were some missing data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 44 | 63.7 | 10.6 |
| Dronabinol | 42 | 73.4 | 21.1 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 43 | 69.1 | 14.4 |
| Placebos | 44 | 60.7 | 9.83 |
| Dronabinol | 42 | 69.5 | 23.8 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 43 | 64.5 | 13.2 |
| Placebos | 44 | 61.1 | 14.1 |
| Dronabinol | 42 | 63.1 | 10.9 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 43 | 64.1 | 11.2 |
| Placebos | 44 | 59.9 | 14.8 |
| Dronabinol | 42 | 69.0 | 23.3 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 43 | 61.7 | 12.1 |
| Placebos | 44 | 59.7 | 13.6 |
| Dronabinol | 42 | 68.7 | 24.9 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 43 | 62.5 | 13.3 |
| Placebos | 44 | 60.8 | 18.5 |
| Dronabinol | 42 | 69.2 | 27.6 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 43 | 61.7 | 12.7 |
The Digit Symbol test measures concentration, psychomotor speed, and graphomotor abilities. This pen and paper test involves having subjects substitute a series of symbols with numbers as quickly and accurately as possible during a 120 second period. The results are expressed as the number of correct substitutions with a score range of 0-133. A higher number indicates better performance.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 44 | 80.3 | 14.9 |
| Dronabinol | 43 | 69.6 | 17.2 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 42 | 72.2 | 15.6 |
| Placebos | 44 | 84.8 | 17.2 |
| Dronabinol | 43 | 73.5 | 19.3 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 42 | 78.3 | 16.7 |
| Placebos | 44 | 88.9 | 17.5 |
| Dronabinol | 43 | 75.6 | 18.2 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 42 | 77.6 | 19.7 |
| Placebos | 44 | 90.0 | 19.7 |
| Dronabinol | 43 | 79.2 | 20.9 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 42 | 83.1 | 18.8 |
| Placebos | 44 | 88.4 | 20.9 |
| Dronabinol | 43 | 79.8 | 19.8 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 42 | 81.0 | 21.3 |
| Placebos | 44 | 84.8 | 22.6 |
| Dronabinol | 43 | 79.3 | 21.9 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 42 | 87.3 | 18.6 |
This questionnaire contains 65 words/statements that describe feelings people have. The questionnaire requires the patient to indicate for each word or statement how he or she has been feeling in the past week. There are 6 subscales: tension-anxiety (9 items, score range: 0-36), depression (15 items, range 0-60), anger-hostility (12 items, range 0-48), vigor-activity (8 items, range 0-32), fatigue (7 items, range 0-28), confusion-bewilderment (7 items, range 0-28). The total mood disturbance (TMD) is calculated by adding the scores for tension-anxiety, depression, anger-hostility, fatigue and confusion-bewilderment and then subtracting the score for vigor-activity. The TMD is reported and has a score range of -32 to 200. A higher score indicates worse symptoms.
Population: There were some missing data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 44 | 57.3 | 32.0 |
| Dronabinol | 42 | 53.8 | 31.5 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 53.2 | 30.6 |
| Placebos | 44 | 51.5 | 36.9 |
| Dronabinol | 42 | 46.2 | 23.6 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 41.5 | 22.2 |
| Placebos | 44 | 48.6 | 30.6 |
| Dronabinol | 42 | 42.9 | 27.4 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 38.8 | 23.3 |
| Placebos | 44 | 46.3 | 27.2 |
| Dronabinol | 42 | 40.0 | 22.7 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 38.8 | 22.0 |
| Placebos | 44 | 45.5 | 27.3 |
| Dronabinol | 42 | 37.7 | 23.7 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 44.2 | 29.2 |
| Placebos | 44 | 42.5 | 30.9 |
| Dronabinol | 42 | 41.0 | 28.5 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 39.7 | 26.6 |
The Beck Depression Inventory is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex. Range of scores is from 0 to 63. A higher score is a worse score.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 41 | 8.05 | 7.99 |
| Dronabinol | 42 | 7.81 | 8.26 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 7.84 | 8.14 |
| Placebos | 41 | 7.68 | 8.70 |
| Dronabinol | 42 | 5.61 | 5.00 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 5.32 | 6.05 |
| Placebos | 41 | 5.76 | 6.59 |
| Dronabinol | 42 | 5.26 | 6.81 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 5.59 | 7.24 |
| Placebos | 41 | 5.32 | 7.07 |
| Dronabinol | 42 | 5.52 | 6.28 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 6.25 | 8.52 |
| Placebos | 41 | 5.50 | 7.63 |
| Dronabinol | 42 | 4.36 | 6.49 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 6.09 | 8.63 |
| Placebos | 41 | 5.32 | 7.39 |
| Dronabinol | 42 | 5.25 | 8.11 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 44 | 6.06 | 9.62 |
Visual Analogue Scale (VAS) ratings will be presented as a 100-mm horizontal line, anchored on the left with 'not at all' and on the right with 'extremely'. Participants will pencil in a vertical line along the horizontal line that represents their current feeling (questions usually phrased, 'During the past week, did you feel \_\_\_after consuming the vaporized cannabis?'). Ratings will be: any drug effect, a good drug effect, a bad drug effect, high, drunk, impaired, stoned, as if you liked the drug effect, sedated, confused, nauseous, like you desired more of the drug, anxious, down, and very hungry. This is a substudy. A good drug effect is presented. Range of scores is from 0 to 100. A higher score is a worse score.
Population: There are some missing values
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 8 | 14.2 | 24.4 |
| Dronabinol | 13 | 19.1 | 34.3 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 21 | 58.8 | 32.5 |
| Placebos | 8 | 14.0 | 23.8 |
| Dronabinol | 13 | 33.5 | 38.5 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 21 | 45.7 | 31.7 |
| Placebos | 8 | 5.88 | 14.3 |
| Dronabinol | 13 | 33.2 | 44.1 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 21 | 27.5 | 29.5 |
| Placebos | 8 | 7.43 | 15.9 |
| Dronabinol | 13 | 36.3 | 42.8 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 21 | 37.0 | 37.5 |
| Placebos | 8 | 11.6 | 28.5 |
| Dronabinol | 13 | 29.7 | 41.9 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 21 | 44.4 | 34.3 |
| Placebos | 8 | 10.7 | 27.0 |
| Dronabinol | 13 | 32.4 | 41.4 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 21 | 40.4 | 35.9 |
The Marijuana subscale (M-scale) of the Addiction Research Center Inventory consists of 12 true or false questions corresponding to symptoms of cannabis intoxication; the minimum and maximum scores are 0 and 12 respectively. A higher score indicates a worse score. The questions were rephrased to evaluate the experience from the past week rather than an acute response to cannabis.
Population: There were missing values.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 37 | 1.59 | 2.02 |
| Dronabinol | 36 | 1.81 | 1.72 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 42 | 2.31 | 2.28 |
| Placebos | 37 | 1.63 | 2.11 |
| Dronabinol | 36 | 2.47 | 2.21 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 42 | 2.33 | 1.91 |
| Placebos | 37 | 1.31 | 2.19 |
| Dronabinol | 36 | 2.93 | 2.51 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 42 | 2.67 | 2.41 |
| Placebos | 37 | 1.61 | 2.41 |
| Dronabinol | 36 | 2.46 | 2.38 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 42 | 2.80 | 2.47 |
| Placebos | 37 | 1.11 | 1.95 |
| Dronabinol | 36 | 2.29 | 2.34 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 42 | 2.31 | 2.36 |
Each Cold Pressure Test will begin with an immersion of the left hand into a warm water bath for 3 min. During this time, blood pressure and heart rate will be measured. After removal of the hand from the warm water, skin temperature of the thumbpad will be recorded and participants will listen to a standardized script describing the procedures. Participants will then immerse the left hand into the cold water bath, and will be instructed to report the first painful sensation after immersion. They will then be asked to tolerate the stimulus as long as possible, but will be permitted to withdraw their hand from the cold water at any point. Maximum immersion time will be 2 min. Latency to first feel pain (pain sensitivity) and latency to withdraw the hand from the water (pain tolerance) will be recorded. Blood pressure and heart rate will be measured before and after each immersion using the arm that was not immersed in the water bath.
Population: There were missing values
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 37 | 20.0 | 26.5 |
| Dronabinol | 33 | 18.3 | 21.8 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 37 | 26.3 | 30.1 |
| Placebos | 37 | 29.4 | 36.9 |
| Dronabinol | 33 | 23.0 | 31.6 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 37 | 20.5 | 29.3 |
| Placebos | 37 | 21.9 | 27.5 |
| Dronabinol | 33 | 18.8 | 22.6 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 37 | 21.0 | 23.5 |
| Placebos | 37 | 20.9 | 28.4 |
| Dronabinol | 33 | 20.4 | 24.8 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 37 | 24.7 | 28.8 |
| Placebos | 37 | 20.4 | 26.6 |
| Dronabinol | 33 | 21.5 | 25.7 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 37 | 20.9 | 24.7 |
| Placebos | 37 | 21.1 | 24.3 |
| Dronabinol | 33 | 15.8 | 11.0 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 37 | 23.9 | 30.6 |
The Cannabis Withdrawal Scale is an assessment tool used to quantify the presence and intensity of various withdrawal symptoms (e.g., strange dreams, mood swings, depression, lack of appetite, and an inability to get to sleep). Range of scores for withdrawal intensity is from 0 to 190. A higher score is a worse score.
Population: Some subjects dropped out before completing the study.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 28 | 13.5 | 23.7 |
| Dronabinol | 27 | 6.12 | 8.98 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 35 | 12.4 | 25.2 |
| Placebos | 28 | 12.7 | 25.1 |
| Dronabinol | 27 | 6.32 | 10.2 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 35 | 9.97 | 20.1 |
Lane Tracking: This task requires subjects to drive down a straight 2-lane road, maintain a constant speed of 55 mph, maintain appropriate lane position, and respond to divided attention tasks in the upper corners of the screen. The primary outcome is standard deviation of lateral deviation (swerving) with a score range of 0.51 - 3.24. A higher score indicates worse performance. The driving simulation assessments are conducted in a substudy, which only includes completers with a valid driver's license and who agreed to participate in the substudy.
Population: There are some missing values
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 5 | 0.75 | 0.18 |
| Dronabinol | 11 | 1.28 | 0.65 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 16 | 1.14 | 0.41 |
| Placebos | 5 | 1.18 | 0.43 |
| Dronabinol | 11 | 1.41 | 0.61 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 16 | 1.12 | 0.32 |
| Placebos | 5 | 1.12 | 0.57 |
| Dronabinol | 11 | 1.78 | 0.87 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 16 | 1.21 | 0.35 |
| Placebos | 5 | 1.31 | 0.57 |
| Dronabinol | 11 | 1.51 | 0.76 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 16 | 1.11 | 0.25 |
| Placebos | 5 | 1.13 | 0.47 |
| Dronabinol | 11 | 1.65 | 0.79 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 16 | 1.24 | 0.39 |
Car Following: This simulation examines the participant's ability to closely match the speed of an automobile in front of them. Participants are to follow a lead vehicle at a safe and constant distance. The primary outcome is coherence between the participant and lead cars (a general correlation \[0-1\] of the participant's ability to accurately track the speed variations of the lead car. A higher score indicates worse performance. The driving simulation assessments are conducted in a substudy, which only includes completers with a valid driver's license and who agreed to participate in the substudy.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 5 | 0.70 | 0.17 |
| Dronabinol | 11 | 0.62 | 0.20 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 16 | 0.49 | 0.29 |
| Placebos | 5 | 0.75 | 0.13 |
| Dronabinol | 11 | 0.71 | 0.20 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 16 | 0.61 | 0.23 |
| Placebos | 5 | 0.59 | 0.33 |
| Dronabinol | 11 | 0.68 | 0.20 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 16 | 0.56 | 0.22 |
| Placebos | 5 | 0.72 | 0.24 |
| Dronabinol | 11 | 0.60 | 0.27 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 16 | 0.62 | 0.25 |
| Placebos | 5 | 0.74 | 0.19 |
| Dronabinol | 11 | 0.68 | 0.26 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 16 | 0.60 | 0.22 |
A total of 15 separate VAS ratings will be presented as a 100-mm horizontal line, anchored on the left with 'not at all' and on the right with 'extremely'. Participants will pencil in a vertical line along the horizontal line that represents their current feeling (questions usually phrased, 'During the past week, did you feel \_\_\_after consuming the vaporized cannabis?'). Ratings will be: any drug effect, a good drug effect, a bad drug effect, high, drunk, impaired, stoned, as if you liked the drug effect, sedated, confused, nauseous, like you desired more of the drug, anxious, down, and very hungry. This is a substudy. Drug "high" will be presented. Range of scores is from 0 to 100. A higher score is a worse score.
Population: There are some missing values
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 8 | 5.38 | 12.2 |
| Dronabinol | 13 | 14.9 | 31.5 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 21 | 49.8 | 30.7 |
| Placebos | 8 | 5.75 | 14.7 |
| Dronabinol | 13 | 25.8 | 38.1 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 21 | 36.7 | 27.1 |
| Placebos | 8 | 5.56 | 13.2 |
| Dronabinol | 13 | 31.8 | 40.5 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 21 | 20.5 | 22.5 |
| Placebos | 8 | 4.00 | 7.00 |
| Dronabinol | 13 | 28.6 | 32.5 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 21 | 29.5 | 32.8 |
| Placebos | 8 | 1.75 | 1.83 |
| Dronabinol | 13 | 21.5 | 36.9 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 21 | 43.9 | 32.8 |
| Placebos | 8 | 1.71 | 3.40 |
| Dronabinol | 13 | 24.8 | 38.7 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 21 | 31.7 | 30.3 |
The Cannabis Withdrawal Scale is an assessment tool used to quantify the presence and intensity of various withdrawal symptoms (e.g., strange dreams, mood swings, depression, lack of appetite, and an inability to get to sleep). The outcome is measured during the tapering period (weeks 8 and 10), at which patients slowly withdrew from medication over two weeks. Range of scores for the negative impact of withdrawal is from 0 to 190. A higher score is a worse score.
Population: Some subjects dropped out before completing the study.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 28 | 8.42 | 22.9 |
| Dronabinol | 27 | 3.42 | 7.22 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 35 | 10.3 | 24.6 |
| Placebos | 28 | 8.18 | 24.0 |
| Dronabinol | 27 | 2.32 | 8.63 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 35 | 4.31 | 10.5 |
Each Cold Pressure Test will begin with an immersion of the left hand into a warm water bath for 3 min. During this time, blood pressure and heart rate will be measured. After removal of the hand from the warm water, skin temperature of the thumbpad will be recorded and participants will listen to a standardized script describing the procedures. Participants will then immerse the left hand into the cold water bath, and will be instructed to report the first painful sensation after immersion. They will then be asked to tolerate the stimulus as long as possible, but will be permitted to withdraw their hand from the cold water at any point. Maximum immersion time will be 2 min. Latency to first feel pain (pain sensitivity) and latency to withdraw the hand from the water (pain tolerance) will be recorded. Blood pressure and heart rate will be measured before and after each immersion using the arm that was not immersed in the water bath.
Population: There were some missing values
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebos | 37 | 47.2 | 42.0 |
| Dronabinol | 33 | 40.6 | 34.1 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 37 | 58.3 | 46.0 |
| Placebos | 37 | 50.5 | 40.4 |
| Dronabinol | 33 | 44.8 | 46.9 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 37 | 60.9 | 48.8 |
| Placebos | 37 | 46.2 | 38.0 |
| Dronabinol | 33 | 40.0 | 34.3 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 37 | 64.3 | 49.3 |
| Placebos | 37 | 41.4 | 39.5 |
| Dronabinol | 33 | 43.6 | 41.5 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 37 | 60.7 | 45.9 |
| Placebos | 37 | 61.7 | 53.8 |
| Dronabinol | 33 | 44.2 | 40.4 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 37 | 54.7 | 42.9 |
| Placebos | 37 | 37.9 | 35.0 |
| Dronabinol | 33 | 37.5 | 32.4 |
| Vaporized Cannabis 3.7% THC/5.6% CBD | 37 | 62.3 | 45.8 |
| Milestone | Placebos | Dronabinol | Vaporized Cannabis 3.7% THC/5.6% CBD |
|---|---|---|---|
| STARTED | 44 | 43 | 44 |
| COMPLETED | 29 | 26 | 36 |
| NOT COMPLETED | 15 | 17 | 8 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Nausea | Gastrointestinal disorders | Placebos: 8 / 44 · Dronabinol: 11 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 11 / 44 |
| Confusion | Nervous system disorders | Placebos: 8 / 44 · Dronabinol: 10 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 7 / 44 |
| Lethargy | Nervous system disorders | Placebos: 19 / 44 · Dronabinol: 16 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 23 / 44 |
| Dry Mouth | Nervous system disorders | Placebos: 8 / 44 · Dronabinol: 19 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 12 / 44 |
| Headache | Nervous system disorders | Placebos: 14 / 44 · Dronabinol: 12 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 14 / 44 |
| Abnormal cognition | Nervous system disorders | Placebos: 3 / 44 · Dronabinol: 10 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 10 / 44 |
| Depression | Nervous system disorders | Placebos: 9 / 44 · Dronabinol: 8 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 6 / 44 |
| Cough | Respiratory, thoracic and mediastinal disorders | Placebos: 4 / 44 · Dronabinol: 8 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 11 / 44 |
| Vomiting | Nervous system disorders | Placebos: 2 / 44 · Dronabinol: 4 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 6 / 44 |
| Dizzy | Nervous system disorders | Placebos: 7 / 44 · Dronabinol: 7 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 9 / 44 |
| Emotional Changes | Nervous system disorders | Placebos: 10 / 44 · Dronabinol: 9 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 14 / 44 |
| Sleeping Problems | Nervous system disorders | Placebos: 0 / 44 · Dronabinol: 1 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 0 / 44 |
| Paranoia | Nervous system disorders | Placebos: 2 / 44 · Dronabinol: 6 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 2 / 44 |
| Stomach Pain | General disorders | Placebos: 2 / 44 · Dronabinol: 6 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 5 / 44 |
| Abnormal Coordination | Nervous system disorders | Placebos: 6 / 44 · Dronabinol: 10 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 8 / 44 |
| Anxiety | Nervous system disorders | Placebos: 8 / 44 · Dronabinol: 7 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 8 / 44 |
| Back/Flank Paresthesia | Nervous system disorders | Placebos: 4 / 44 · Dronabinol: 6 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 6 / 44 |
| Abnormal Dreams | Nervous system disorders | Placebos: 5 / 44 · Dronabinol: 3 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 8 / 44 |
| Back/Flank Numbness | Nervous system disorders | Placebos: 6 / 44 · Dronabinol: 1 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 3 / 44 |
| Abnormal Balance | Nervous system disorders | Placebos: 1 / 44 · Dronabinol: 2 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 1 / 44 |
| Orthostatic Hypotension | Nervous system disorders | Placebos: 3 / 44 · Dronabinol: 1 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 2 / 44 |
| Abnormal heart rate | Nervous system disorders | Placebos: 2 / 44 · Dronabinol: 2 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 4 / 44 |
| Vision Alteration | Nervous system disorders | Placebos: 2 / 44 · Dronabinol: 3 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 2 / 44 |
| Blood pressure decreased | Nervous system disorders | Placebos: 1 / 44 · Dronabinol: 2 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 1 / 44 |
| Abdomen/Groin/Pelvis Pain | Nervous system disorders | Placebos: 2 / 44 · Dronabinol: 2 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 2 / 44 |
| Blood pressure increased | Nervous system disorders | Placebos: 0 / 44 · Dronabinol: 1 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 1 / 44 |
| Face/Jaw/Lips dry | General disorders | Placebos: 0 / 44 · Dronabinol: 1 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 1 / 44 |
| Generalized/Multiple site numbness | Nervous system disorders | Placebos: 0 / 44 · Dronabinol: 2 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 0 / 44 |
| Behavior changes | Nervous system disorders | Placebos: 1 / 44 · Dronabinol: 1 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 0 / 44 |
| Bronchial washing nausea | Nervous system disorders | Placebos: 0 / 44 · Dronabinol: 1 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 1 / 44 |
| Cronic bronchitis | Nervous system disorders | Placebos: 0 / 44 · Dronabinol: 1 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 0 / 44 |
| Sexual drive alteration | Nervous system disorders | Placebos: 1 / 44 · Dronabinol: 1 / 43 · Vaporized Cannabis 3.7% THC/5.6% CBD: 0 / 44 |
Time frame: 8 weeks
The Digit Symbol test measures concentration, psychomotor speed, and graphomotor abilities. This pen and paper test involves having subjects substitute a series of symbols with numbers as quickly and accurately as possible during a 120 second period. The results are expressed as the number of correct substitutions with a score range of 0-133. A higher number indicates better performance.
Time frame: 8 weeks
This questionnaire contains 65 words/statements that describe feelings people have. The questionnaire requires the patient to indicate for each word or statement how he or she has been feeling in the past week. There are 6 subscales: tension-anxiety (9 items, score range: 0-36), depression (15 items, range 0-60), anger-hostility (12 items, range 0-48), vigor-activity (8 items, range 0-32), fatigue (7 items, range 0-28), confusion-bewilderment (7 items, range 0-28). The total mood disturbance (TMD) is calculated by adding the scores for tension-anxiety, depression, anger-hostility, fatigue and confusion-bewilderment and then subtracting the score for vigor-activity. The TMD is reported and has a score range of -32 to 200. A higher score indicates worse symptoms.
Time frame: 8 weeks
The Beck Depression Inventory is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex. Range of scores is from 0 to 63. A higher score is a worse score.
Time frame: 6 hours
Visual Analogue Scale (VAS) ratings will be presented as a 100-mm horizontal line, anchored on the left with 'not at all' and on the right with 'extremely'. Participants will pencil in a vertical line along the horizontal line that represents their current feeling (questions usually phrased, 'During the past week, did you feel \_\_\_after consuming the vaporized cannabis?'). Ratings will be: any drug effect, a good drug effect, a bad drug effect, high, drunk, impaired, stoned, as if you liked the drug effect, sedated, confused, nauseous, like you desired more of the drug, anxious, down, and very hungry. This is a substudy. A good drug effect is presented. Range of scores is from 0 to 100. A higher score is a worse score.
Time frame: 8 weeks
The Marijuana subscale (M-scale) of the Addiction Research Center Inventory consists of 12 true or false questions corresponding to symptoms of cannabis intoxication; the minimum and maximum scores are 0 and 12 respectively. A higher score indicates a worse score. The questions were rephrased to evaluate the experience from the past week rather than an acute response to cannabis.
Time frame: 8 weeks
Each Cold Pressure Test will begin with an immersion of the left hand into a warm water bath for 3 min. During this time, blood pressure and heart rate will be measured. After removal of the hand from the warm water, skin temperature of the thumbpad will be recorded and participants will listen to a standardized script describing the procedures. Participants will then immerse the left hand into the cold water bath, and will be instructed to report the first painful sensation after immersion. They will then be asked to tolerate the stimulus as long as possible, but will be permitted to withdraw their hand from the cold water at any point. Maximum immersion time will be 2 min. Latency to first feel pain (pain sensitivity) and latency to withdraw the hand from the water (pain tolerance) will be recorded. Blood pressure and heart rate will be measured before and after each immersion using the arm that was not immersed in the water bath.
Time frame: Week 8 and Week 10
The Cannabis Withdrawal Scale is an assessment tool used to quantify the presence and intensity of various withdrawal symptoms (e.g., strange dreams, mood swings, depression, lack of appetite, and an inability to get to sleep). Range of scores for withdrawal intensity is from 0 to 190. A higher score is a worse score.
Time frame: 270 minutes
Lane Tracking: This task requires subjects to drive down a straight 2-lane road, maintain a constant speed of 55 mph, maintain appropriate lane position, and respond to divided attention tasks in the upper corners of the screen. The primary outcome is standard deviation of lateral deviation (swerving) with a score range of 0.51 - 3.24. A higher score indicates worse performance. The driving simulation assessments are conducted in a substudy, which only includes completers with a valid driver's license and who agreed to participate in the substudy.
Time frame: 270 minutes
Car Following: This simulation examines the participant's ability to closely match the speed of an automobile in front of them. Participants are to follow a lead vehicle at a safe and constant distance. The primary outcome is coherence between the participant and lead cars (a general correlation \[0-1\] of the participant's ability to accurately track the speed variations of the lead car. A higher score indicates worse performance. The driving simulation assessments are conducted in a substudy, which only includes completers with a valid driver's license and who agreed to participate in the substudy.
Time frame: 6 hours
A total of 15 separate VAS ratings will be presented as a 100-mm horizontal line, anchored on the left with 'not at all' and on the right with 'extremely'. Participants will pencil in a vertical line along the horizontal line that represents their current feeling (questions usually phrased, 'During the past week, did you feel \_\_\_after consuming the vaporized cannabis?'). Ratings will be: any drug effect, a good drug effect, a bad drug effect, high, drunk, impaired, stoned, as if you liked the drug effect, sedated, confused, nauseous, like you desired more of the drug, anxious, down, and very hungry. This is a substudy. Drug "high" will be presented. Range of scores is from 0 to 100. A higher score is a worse score.
Time frame: Week 8, Week 10
The Cannabis Withdrawal Scale is an assessment tool used to quantify the presence and intensity of various withdrawal symptoms (e.g., strange dreams, mood swings, depression, lack of appetite, and an inability to get to sleep). The outcome is measured during the tapering period (weeks 8 and 10), at which patients slowly withdrew from medication over two weeks. Range of scores for the negative impact of withdrawal is from 0 to 190. A higher score is a worse score.
Time frame: 8 weeks
Each Cold Pressure Test will begin with an immersion of the left hand into a warm water bath for 3 min. During this time, blood pressure and heart rate will be measured. After removal of the hand from the warm water, skin temperature of the thumbpad will be recorded and participants will listen to a standardized script describing the procedures. Participants will then immerse the left hand into the cold water bath, and will be instructed to report the first painful sensation after immersion. They will then be asked to tolerate the stimulus as long as possible, but will be permitted to withdraw their hand from the cold water at any point. Maximum immersion time will be 2 min. Latency to first feel pain (pain sensitivity) and latency to withdraw the hand from the water (pain tolerance) will be recorded. Blood pressure and heart rate will be measured before and after each immersion using the arm that was not immersed in the water bath.