Cannabis
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
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This study will use a randomized controlled design to test whether medical marijuana use by adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain is associated with reduced opioid dose and improved pain intensity and interference when added to a 24-week behavioral intervention (POTS).
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-06-24
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
This trial is a randomized, six-month study of cannabis (CB) on opioid use that will: (1) evaluate whether adults with chronic, non-cancer pain on COT assigned to CB, compared with those assigned to a waitlist control condition (WL), have greater reduction in opioid dose and/or pain intensity and interference, (2) assess whether participants assigned to CB, compared with those assigned to WL, have improved quality of life, depression, and anxiety; and reduced self-reported opioid dose, (3) evaluate whether those assigned to CB develop symptoms of CUD and have a reduced number of OUD symptoms over the 24-week intervention, as well as at the 12-month time point. Participants will be randomly assigned to either an active CB arm (n = 60), or to a waitlist control arm (WL) (n = 60). Participants will be assessed at baseline, every 4 weeks for 6 months, and at a 12-month follow-up for opioid use, development of CUD, development or resolution of OUD, and neurocognitive performance. Urine collected will be assessed with quantitative assays.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All participants were offered weekly group Prescription Opioid Taper Support (POTS) sessions for 24 weeks. POTS is behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering. This intervention was adapted for this trial to include group-based delivery. Sessions are one hour delivered via teleconference and incorporated cognitive behavioral, mindfulness-based, and motivational interviewing strategies.
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Median opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day, over monthly interval preceding study visit.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabis (CB) | 42 | 113.3 | 84.7 to 141.9 |
| Waitlist (WL) | 45 | 97.9 | 70.2 to 125.6 |
The Pain, Enjoyment, General Activity (PEG) scale assesses pain intensity and interference. The scale ranges from 0 to 10, with a higher score indicating greater pain intensity and interference. PEG score was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
One participant from the CB group and eight participants from the WL group were excluded due to them completing less than 14 days of daily surveys.
Eligibility
primary outcomes
Time frame: Week 24
Median opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day, over monthly interval preceding study visit.
Time frame: Every post-baseline day until week 24
The Pain, Enjoyment, General Activity (PEG) scale assesses pain intensity and interference. The scale ranges from 0 to 10, with a higher score indicating greater pain intensity and interference. PEG score was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
secondary outcomes
Time frame: Every post-baseline day until week 24
Self-reported opioid dose in morphine milligram equivalents (MME) per day. Self-reported opioid dose was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Time frame: Week 4, week 8, week 12, week 16, week 20, week 24
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form assesses changes in quality of life measures. The scale ranges from 14 - 70, with a lower score indicating greater dissatisfaction with life. Q-LES-SF score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Time frame: Week 4, week 8, week 12, week 16, week 20, week 24
The 8-item depression subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess depression symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse depression. PROMIS-29 depression subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Time frame: Week 4, week 8, week 12, week 16, week 20, week 24
The 7-item anxiety subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess anxiety symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse anxiety. PROMIS-29 anxiety subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Publications
No exact PMID-linked public article is currently readable locally.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabis (CB) | 41 | 5.35 | 4.98 to 5.73 |
| Waitlist (WL) | 37 | 5.30 | 4.89 to 5.72 |
Self-reported opioid dose in morphine milligram equivalents (MME) per day. Self-reported opioid dose was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Population: One participant from the CB group and eight participants from the WL group were excluded due to not completing at least 14 days of daily surveys.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabis (CB) | 41 | 84.0 | 68.4 to 99.6 |
| Waitlist (WL) | 37 | 89.6 | 71.1 to 108.0 |
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form assesses changes in quality of life measures. The scale ranges from 14 - 70, with a lower score indicating greater dissatisfaction with life. Q-LES-SF score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabis (CB) | 42 | 45.5 | 42.9 to 48.0 |
| Waitlist (WL) | 45 | 47.3 | 44.6 to 49.9 |
The 8-item depression subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess depression symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse depression. PROMIS-29 depression subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabis (CB) | 42 | 52.7 | 50.8 to 54.5 |
| Waitlist (WL) | 45 | 52.4 | 50.5 to 54.3 |
The 7-item anxiety subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess anxiety symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse anxiety. PROMIS-29 anxiety subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabis (CB) | 42 | 53.2 | 51.2 to 55.3 |
| Waitlist (WL) | 45 | 50.1 | 48.0 to 52.1 |
Number of opioid use disorder (OUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. As all participants were taking prescribed opioids under the supervision of a clinician, symptom counts exclude tolerance and withdrawal. Number of symptoms range from 0 to 9. A score of 2 or more indicates a current opioid use disorder diagnosis. Number of opioid use disorder symptoms were assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabis (CB) | 42 | 1.14 | 0.82 to 1.47 |
| Waitlist (WL) | 45 | 1.27 | 0.93 to 1.61 |
Number of cannabis use disorder (CUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. Number of symptoms range from 0 to 11. A score of 2 or more indicates a current cannabis use disorder diagnosis. The number of cannabis use disorder symptoms were assessed at weeks 12 and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabis (CB) | 42 | 0.54 | 0.36 to 0.72 |
| Waitlist (WL) | 45 | 0.03 | -0.13 to 0.19 |
| Milestone | Cannabis (CB) | Waitlist (WL) |
|---|---|---|
| STARTED | 42 | 45 |
| COMPLETED | 42 | 45 |
| NOT COMPLETED | 0 | 0 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Intrathecal Pump Insertion | Surgical and medical procedures | Cannabis (CB): 0 / 42 · Waitlist (WL): 1 / 45 |
| Abdominal Pain | Gastrointestinal disorders | Cannabis (CB): 0 / 42 · Waitlist (WL): 1 / 45 |
| Catheter Blockage | Product Issues | Cannabis (CB): 0 / 42 · Waitlist (WL): 1 / 45 |
| Cervical disk herniation | Musculoskeletal and connective tissue disorders | Cannabis (CB): 0 / 42 · Waitlist (WL): 1 / 45 |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Cannabis (CB): 1 / 42 · Waitlist (WL): 0 / 45 |
| Dog bite | Injury, poisoning and procedural complications | Cannabis (CB): 1 / 42 · Waitlist (WL): 0 / 45 |
| Hospitalizations | Surgical and medical procedures | Cannabis (CB): 1 / 42 · Waitlist (WL): 1 / 45 |
| Hypotension | Vascular disorders | Cannabis (CB): 1 / 42 · Waitlist (WL): 0 / 45 |
| Knee replacement surgery | Surgical and medical procedures | Cannabis (CB): 0 / 42 · Waitlist (WL): 1 / 45 |
| Opiate withdrawal symptoms | General disorders | Cannabis (CB): 1 / 42 · Waitlist (WL): 0 / 45 |
| Osteomyelitis (acute) | Infections and infestations | Cannabis (CB): 1 / 42 · Waitlist (WL): 0 / 45 |
| Rib fracture | Injury, poisoning and procedural complications | Cannabis (CB): 1 / 42 · Waitlist (WL): 0 / 45 |
| Transient ischemic attack | Nervous system disorders | Cannabis (CB): 1 / 42 · Waitlist (WL): 0 / 45 |
| Vomiting | Gastrointestinal disorders | Cannabis (CB): 0 / 42 · Waitlist (WL): 1 / 45 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Pain and discomfort | General disorders | Cannabis (CB): 13 / 42 · Waitlist (WL): 16 / 45 |
| Anxiety symptoms | Psychiatric disorders | Cannabis (CB): 12 / 42 · Waitlist (WL): 4 / 45 |
| Non-site specific injuries | Injury, poisoning and procedural complications | Cannabis (CB): 11 / 42 · Waitlist (WL): 4 / 45 |
| Depressive disorders | Psychiatric disorders | Cannabis (CB): 10 / 42 · Waitlist (WL): 10 / 45 |
| Musculoskeletal and connective tissue pain and discomfort | Musculoskeletal and connective tissue disorders | Cannabis (CB): 8 / 42 · Waitlist (WL): 9 / 45 |
| Analgesia supportive care | Surgical and medical procedures | Cannabis (CB): 6 / 42 · Waitlist (WL): 5 / 45 |
| General signs and symptoms | General disorders | Cannabis (CB): 6 / 42 · Waitlist (WL): 5 / 45 |
| Withdrawal and rebound effects | General disorders | Cannabis (CB): 6 / 42 · Waitlist (WL): 4 / 45 |
| Emotional and mood disturbances | Psychiatric disorders | Cannabis (CB): 5 / 42 · Waitlist (WL): 0 / 45 |
| General nutritional disorders | Metabolism and nutrition disorders | Cannabis (CB): 5 / 42 · Waitlist (WL): 0 / 45 |
| Infection | Infections and infestations | Cannabis (CB): 5 / 42 · Waitlist (WL): 0 / 45 |
| Appetite disorders | Metabolism and nutrition disorders | Cannabis (CB): 4 / 42 · Waitlist (WL): 0 / 45 |
| Bone and joint injuries | Injury, poisoning and procedural complications | Cannabis (CB): 4 / 42 · Waitlist (WL): 3 / 45 |
| Diarrhea | Gastrointestinal disorders | Cannabis (CB): 4 / 42 · Waitlist (WL): 0 / 45 |
| Nausea and vomiting symptoms | Gastrointestinal disorders | Cannabis (CB): 4 / 42 · Waitlist (WL): 0 / 45 |
| Sleep disorders | Psychiatric disorders | Cannabis (CB): 4 / 42 · Waitlist (WL): 5 / 45 |
| Coronavirus infection | Infections and infestations | Cannabis (CB): 3 / 42 · Waitlist (WL): 5 / 45 |
| Imaging procedures | Investigations | Cannabis (CB): 3 / 42 · Waitlist (WL): 0 / 45 |
| Mental impairment (excluding dementia and memory loss) | Nervous system disorders | Cannabis (CB): 3 / 42 · Waitlist (WL): 0 / 45 |
| Nasal congestion and inflammation | Respiratory, thoracic and mediastinal disorders | Cannabis (CB): 3 / 42 · Waitlist (WL): 0 / 45 |
Time frame: Week 4, week 8, week 12, week 16, week 20, week 24
Number of opioid use disorder (OUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. As all participants were taking prescribed opioids under the supervision of a clinician, symptom counts exclude tolerance and withdrawal. Number of symptoms range from 0 to 9. A score of 2 or more indicates a current opioid use disorder diagnosis. Number of opioid use disorder symptoms were assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Time frame: Week 12, Week 24
Number of cannabis use disorder (CUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. Number of symptoms range from 0 to 11. A score of 2 or more indicates a current cannabis use disorder diagnosis. The number of cannabis use disorder symptoms were assessed at weeks 12 and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
| Neurological signs and symptoms | Nervous system disorders | Cannabis (CB): 3 / 42 · Waitlist (WL): 0 / 45 |
| Therapeutic procedures | Surgical and medical procedures | Cannabis (CB): 3 / 42 · Waitlist (WL): 3 / 45 |
| Urinary tract infection | Infections and infestations | Cannabis (CB): 3 / 42 · Waitlist (WL): 3 / 45 |
| Upper respiratory tract infection | Infections and infestations | Cannabis (CB): 2 / 42 · Waitlist (WL): 3 / 45 |
| Dental and gingival therapeutic procedures | Surgical and medical procedures | Cannabis (CB): 0 / 42 · Waitlist (WL): 6 / 45 |