Placebo
Matching placebo twice daily for first 4 weeks
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The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of our project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD. This next phase is to determine whether CBD can serve as a potential adjunct treatment to reduce craving and anxiety in individuals with OUD maintained on opioid agonist therapy.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-06-18
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
In this Phase 2 study, the research team will conduct a double-blind (placebo-controlled) randomized controlled trial to evaluate whether 200mg and/or 400mg CBD (BSPG Laboratories) given twice daily (morning and evening), as compared to placebo, reduces cue-induced craving and anxiety in individuals with opioid use disorder who are maintained on methadone or buprenorphine. In addition to in-lab physiological and behavioral assessments of cue-induced craving and anxiety, the research team will also employ ecological momentary assessment to obtain real-world measures of symptoms including craving, anxiety, and mood.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Matching placebo twice daily for first 4 weeks
First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale ranges from 0-10, with higher scores indicating extreme cravings.
Population: Results provide for participants who responded to the respective cues at both timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD 200mg, Then CBD 400mg | 29 | 0.54 | 1.8 |
| Methadone Placebo, Then CBD 400mg | 26 | 0.31 | 1.6 |
| Buprenorphine CBD 200mg, Then CBD 400mg | 8 | 0.25 | 0.5 |
| Buprenorphine Placebo, Then CBD 400mg | 5 | -0.20 | 0.8 |
| Methadone CBD 200mg, Then CBD 400mg | 29 | 0.07 | 2.2 |
| Methadone Placebo, Then CBD 400mg | 26 | 0.04 | 1.1 |
| Buprenorphine CBD 200mg, Then CBD 400mg | 8 | 0.13 | 1.0 |
| Buprenorphine Placebo, Then CBD 400mg | 5 | -1.20 | 3.3 |
Eligibility
primary outcomes
Time frame: Baseline and 4 weeks
Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale ranges from 0-10, with higher scores indicating extreme cravings.
Time frame: Baseline and 4-weeks
Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale from 0-10, with higher score indicating extreme anxiety.
Time frame: 4-weeks
Percentage of participants with positive urine toxicology for illicit opioid use at 4 weeks.
Time frame: weekly for 8 weeks (Baseline, Week 1, 2, 3, 4, 5, 6, 7, and 8)
Systematic Assessment for Treatment Emergent Events (SAFTEE) is used to measure safety and tolerability. SAFTEE is a side effect self-report assessment scale that consists of 56 potential side effects. Participants rate how bothersome each side effect is on a scale of "none" (0), "mild" (1), "moderate" (2), "severe" (3). Total score ranges 0 - 168, higher scores indicate a higher level of side effect burden.
secondary outcomes
Time frame: 4-weeks and 8-weeks
Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving at 8 weeks as compared to 4 weeks (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving). Higher score indicates more extreme craving.
Time frame: 4-weeks and 8-weeks
Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety at 8 weeks as compared to 4 weeks (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Scale: 0 (not at all anxious) - 10 (extremely anxious). Higher score indicates more extreme anxiety.
Time frame: 4 weeks and 8 weeks
Proportion of percentage with positive urine toxicology for illicit opioid use at 8 weeks as compared to 4 weeks.
Time frame: baseline and 4-weeks, 4-weeks and 8-weeks
Heroin Craving Questionnaire Short Form (HCQ-SF-14): A 15 minute, 14 item self-administered to measure general heroin craving. Each item is rated on a 7-point Likert scale (1= strongly disagree, 7= strongly agree). Full scale ranges from 14-98, with higher scores indicating more severe heroin craving.
Time frame: Baseline and 4-weeks, 4-weeks and 8-weeks
The General Anxiety Disorder 7-item questionnaire (GAD-7) assesses seven problem items potentially experienced over the past two weeks from "0" (not at all) to "3" (nearly every day). Individuals rank their levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more anxiety symptoms.
Time frame: any time during study, 8 weeks
Publications
No exact PMID-linked public article is currently readable locally.
Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale from 0-10, with higher score indicating extreme anxiety.
Population: Results provide for participants who responded to the respective cues at both timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 29 | 0.82 | 1.9 |
| Methadone Placebo | 26 | 0.00 | 1.3 |
| Buprenorphine CBD | 8 | 1.25 | 1.7 |
| Buprenorphine Placebo | 5 | 0.60 | 1.8 |
| Methadone CBD | 29 | -0.48 | 2.8 |
| Methadone Placebo | 26 | 0.25 | 1.4 |
| Buprenorphine CBD | 8 | 1.00 | 1.7 |
| Buprenorphine Placebo | 5 | 0.80 | 5.2 |
Percentage of participants with positive urine toxicology for illicit opioid use at 4 weeks.
Population: Results provide for participants who provided urine sample at 4 weeks.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 29 | 75.90 | - |
| Methadone Placebo | 26 | 80.80 | - |
| Buprenorphine CBD | 8 | 12.5 | - |
| Buprenorphine Placebo | 5 | 20.00 | - |
Systematic Assessment for Treatment Emergent Events (SAFTEE) is used to measure safety and tolerability. SAFTEE is a side effect self-report assessment scale that consists of 56 potential side effects. Participants rate how bothersome each side effect is on a scale of "none" (0), "mild" (1), "moderate" (2), "severe" (3). Total score ranges 0 - 168, higher scores indicate a higher level of side effect burden.
Population: Result provided for participants who completed the assessment for the respective week.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 32 | 0.03 | 0.2 |
| Methadone Placebo | 30 | 0.03 | 0.2 |
| Buprenorphine CBD | 8 | 0.00 | 0.00 |
| Buprenorphine Placebo | 6 | 0.00 | 0.00 |
| Methadone CBD | 32 | 0.16 | 0.5 |
| Methadone Placebo | 30 | 0.39 | 0.8 |
| Buprenorphine CBD | 8 | 0.25 | 0.5 |
| Buprenorphine Placebo | 6 | 0.50 | 0.8 |
| Methadone CBD | 32 | 0.07 | 0.4 |
| Methadone Placebo | 30 | 0.11 | 0.3 |
| Buprenorphine CBD | 8 | 0.13 | 0.4 |
| Buprenorphine Placebo | 6 | 0.20 | 0.4 |
| Methadone CBD | 32 | 0.00 | 0.00 |
| Methadone Placebo | 30 | 0.08 | 0.3 |
| Buprenorphine CBD | 8 | 0.00 | 0.0 |
| Buprenorphine Placebo | 6 | 0.00 | 0.0 |
| Methadone CBD | 32 | 0.03 | 0.2 |
| Methadone Placebo | 30 | 0.04 | 0.2 |
| Buprenorphine CBD | 8 | 0.00 | 0.0 |
| Buprenorphine Placebo | 6 | 0.00 | 0.0 |
| Methadone CBD | 32 | 0.31 | 0.6 |
| Methadone Placebo | 30 | 0.46 | 0.9 |
| Buprenorphine CBD | 8 | 0.13 | 0.4 |
| Buprenorphine Placebo | 6 | 0.00 | 0.0 |
| Methadone CBD | 32 | 0.14 | 0.4 |
| Methadone Placebo | 30 | 0.15 | 0.5 |
| Buprenorphine CBD | 8 | 0.38 | 0.5 |
| Buprenorphine Placebo | 6 | 0.00 | 0.0 |
| Methadone CBD | 32 | 0.00 | 0.0 |
| Methadone Placebo | 30 | 0.04 | 0.2 |
| Buprenorphine CBD | 8 | 0.13 | 0.5 |
| Buprenorphine Placebo | 6 | 0.20 | 0.4 |
| Methadone CBD | 32 | 0.11 | 0.4 |
| Methadone Placebo | 30 | 0.19 | 0.5 |
| Buprenorphine CBD | 8 | 0.13 | 0.4 |
| Buprenorphine Placebo | 6 | 0.00 | 0.0 |
Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving at 8 weeks as compared to 4 weeks (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving). Higher score indicates more extreme craving.
Population: Results provide for participants with data for both timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 27 | 0.37 | 1.3 |
| Methadone Placebo | 24 | -0.08 | 0.8 |
| Buprenorphine CBD | 5 | 0.00 | 0.0 |
| Buprenorphine Placebo | 5 | 0.40 | 0.5 |
| Methadone CBD | 27 | -0.59 | 2.1 |
| Methadone Placebo | 24 | -0.21 | 0.9 |
| Buprenorphine CBD | 5 | -0.40 | 0.9 |
| Buprenorphine Placebo | 5 | -0.20 | 0.4 |
Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety at 8 weeks as compared to 4 weeks (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Scale: 0 (not at all anxious) - 10 (extremely anxious). Higher score indicates more extreme anxiety.
Population: Results provide for participants with data for both timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 27 | 0.22 | 1.8 |
| Methadone Placebo | 24 | 0.04 | 1.5 |
| Buprenorphine CBD | 5 | -1.00 | 2.2 |
| Buprenorphine Placebo | 5 | 1.60 | 2.7 |
| Methadone CBD | 27 | -0.48 | 2.8 |
| Methadone Placebo | 24 | 0.25 | 1.4 |
| Buprenorphine CBD | 5 | 1.00 | 1.7 |
| Buprenorphine Placebo | 5 | 0.80 | 5.2 |
Proportion of percentage with positive urine toxicology for illicit opioid use at 8 weeks as compared to 4 weeks.
Population: Results provide for participants with data for both timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 28 | -4.5 | - |
| Methadone Placebo | 26 | -3.9 | - |
| Buprenorphine CBD | 8 | 25 | - |
| Buprenorphine Placebo | 5 | -20 | - |
Heroin Craving Questionnaire Short Form (HCQ-SF-14): A 15 minute, 14 item self-administered to measure general heroin craving. Each item is rated on a 7-point Likert scale (1= strongly disagree, 7= strongly agree). Full scale ranges from 14-98, with higher scores indicating more severe heroin craving.
Population: Results provide for participants with data for specified timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 27 | -0.24 | 1.1 |
| Methadone Placebo | 25 | -0.26 | 0.8 |
| Buprenorphine CBD | 7 | -0.48 | 0.7 |
| Buprenorphine Placebo | 5 | -0.60 | 0.3 |
| Methadone CBD | 27 | -0.11 | 0.8 |
| Methadone Placebo | 25 | -0.20 | 0.7 |
| Buprenorphine CBD | 7 | -0.11 | 0.5 |
| Buprenorphine Placebo | 5 | 0.04 | 1.0 |
The General Anxiety Disorder 7-item questionnaire (GAD-7) assesses seven problem items potentially experienced over the past two weeks from "0" (not at all) to "3" (nearly every day). Individuals rank their levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more anxiety symptoms.
Population: Results provide for participants with data for specified timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 29 | 0.00 | 4.5 |
| Methadone Placebo | 26 | -1.42 | 2.8 |
| Buprenorphine CBD | 8 | -3.38 | 4.7 |
| Buprenorphine Placebo | 5 | -2.40 | 2.3 |
| Methadone CBD | 29 | -1.41 | 3.5 |
| Methadone Placebo | 26 | -0.32 | 2.8 |
| Buprenorphine CBD | 8 | -0.33 | 2.6 |
| Buprenorphine Placebo | 5 | 2.80 | 3.7 |
Population: Results only include participants who started with positive urine toxicology for illicit opioids at baseline.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 23 | 6.48 | 2.5 |
| Methadone Placebo | 19 | 6.26 | 2.5 |
| Buprenorphine CBD | 1 | 8.00 | NA |
| Buprenorphine Placebo | 2 | 1.00 | 0.0 |
The Questionnaire Type 9 for Depression (PHQ-9) measures depression severity with the nine DSM-IV criteria scored as "0" (not at all) to "3" (nearly every day). Full scale ranges from 0-27, with higher score indicating more severe symptoms.
Population: Results provide for participants with data for specified timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 29 | -1.21 | 4.9 |
| Methadone Placebo | 26 | -1.42 | 4.5 |
| Buprenorphine CBD | 8 | -3.13 | 4.1 |
| Buprenorphine Placebo | 5 | -2.40 | 3.0 |
| Methadone CBD | 29 | -2.52 | 5.5 |
| Methadone Placebo | 26 | -0.72 | 3.6 |
| Buprenorphine CBD | 8 | -0.50 | 1.5 |
| Buprenorphine Placebo | 5 | 1.80 | 4.1 |
A 20 item self-administered questionnaire evaluating current positive and negative affect. Each item is rated on a 5-point scale (0= Very slightly or not at all, 5= Extremely). Scores range from 10 - 50 for both sets of items. For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect.
Population: Results provide for participants with data for specified timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 32 | 29.90 | 8.6 |
| Methadone Placebo | 30 | 28.77 | 8.8 |
| Buprenorphine CBD | 8 | 33.38 | 10.5 |
| Buprenorphine Placebo | 6 | 25.17 | 11.8 |
| Methadone CBD | 32 | 29.44 | 9.6 |
| Methadone Placebo | 30 | 28.03 | 8.8 |
| Buprenorphine CBD | 8 | 32.13 | 8.7 |
| Buprenorphine Placebo | 6 | 23.00 | 13.5 |
| Methadone CBD | 32 | 28.31 | 9.3 |
| Methadone Placebo | 30 | 28.90 | 9.7 |
| Buprenorphine CBD | 8 | 30.50 | 9.5 |
| Buprenorphine Placebo | 6 | 21.00 | 13.1 |
| Methadone CBD | 32 | 28.56 | 10.1 |
| Methadone Placebo | 30 | 27.20 | 9.8 |
| Buprenorphine CBD | 8 | 31.13 | 12.6 |
| Buprenorphine Placebo | 6 | 22.33 | 15.0 |
| Methadone CBD | 32 | 29.52 | 7.7 |
| Methadone Placebo | 30 | 31.31 | 9.2 |
| Buprenorphine CBD | 8 | 32.13 | 14.1 |
| Buprenorphine Placebo | 6 | 26.60 | 14.7 |
| Methadone CBD | 32 | 28.34 | 7.9 |
| Methadone Placebo | 30 | 29.77 | 9.9 |
| Buprenorphine CBD | 8 | 32.50 | 14.0 |
| Buprenorphine Placebo | 6 | 23.00 | 14.7 |
| Methadone CBD | 32 | 28.07 | 7.9 |
| Methadone Placebo | 30 | 30.00 | 9.3 |
| Buprenorphine CBD | 8 | 31.50 | 13.9 |
| Buprenorphine Placebo | 6 | 22.40 | 15.9 |
| Methadone CBD | 32 | 28.10 | 9.5 |
| Methadone Placebo | 30 | 29.65 | 9.7 |
| Buprenorphine CBD | 8 | 30.88 | 14.5 |
| Buprenorphine Placebo | 6 | 22.00 | 16.3 |
| Methadone CBD | 32 | 29.00 | 9.1 |
| Methadone Placebo | 30 | 28.46 | 11.2 |
| Buprenorphine CBD | 8 | 38.60 | 7.4 |
| Buprenorphine Placebo | 6 | 23.80 | 13.3 |
| Methadone CBD | 32 | 28.22 | 9.3 |
| Methadone Placebo | 30 | 25.79 | 12.3 |
| Buprenorphine CBD | 8 | 31.00 | 6.9 |
| Buprenorphine Placebo | 6 | 24.20 | 13.7 |
| Methadone CBD | 32 | 28.67 | 10.3 |
| Methadone Placebo | 30 | 27.17 | 12.3 |
| Buprenorphine CBD | 8 | 34.60 | 7.5 |
| Buprenorphine Placebo | 6 | 22.60 | 15.1 |
| Methadone CBD | 32 | 27.04 | 10.5 |
| Methadone Placebo | 30 | 28.21 | 12.4 |
| Buprenorphine CBD | 8 | 34.20 | 7.4 |
| Buprenorphine Placebo | 6 | 22.20 | 14.7 |
| Methadone CBD | 32 | 14.48 | 4.6 |
| Methadone Placebo | 30 | 13.53 | 4.8 |
| Buprenorphine CBD | 8 | 14.88 | 4.6 |
| Buprenorphine Placebo | 6 | 10.67 | 0.8 |
| Methadone CBD | 32 | 14.25 | 5.1 |
| Methadone Placebo | 30 | 13.07 | 3.8 |
| Buprenorphine CBD | 8 | 13.63 | 2.4 |
| Buprenorphine Placebo | 6 | 13.17 | 6.8 |
| Methadone CBD | 32 | 13.06 | 3.8 |
| Methadone Placebo | 30 | 12.23 | 3.7 |
| Buprenorphine CBD | 8 | 11.38 | 1.3 |
| Buprenorphine Placebo | 6 | 10.67 | 0.8 |
| Methadone CBD | 32 | 14.66 | 4.3 |
| Methadone Placebo | 30 | 12.13 | 3.1 |
| Buprenorphine CBD | 8 | 11.38 | 1.9 |
| Buprenorphine Placebo | 6 | 11.67 | 2.4 |
| Methadone CBD | 32 | 13.21 | 4.8 |
| Methadone Placebo | 30 | 13.38 | 6.2 |
| Buprenorphine CBD | 8 | 15.50 | 9.4 |
| Buprenorphine Placebo | 6 | 11.20 | 2.2 |
| Methadone CBD | 32 | 13.66 | 5.2 |
| Methadone Placebo | 30 | 13.12 | 5.7 |
| Buprenorphine CBD | 8 | 14.13 | 7.8 |
| Buprenorphine Placebo | 6 | 11.40 | 1.9 |
| Methadone CBD | 32 | 12.21 | 3.8 |
| Methadone Placebo | 30 | 12.31 | 5.5 |
| Buprenorphine CBD | 8 | 13.25 | 6.5 |
| Buprenorphine Placebo | 6 | 10.60 | 0.9 |
| Methadone CBD | 32 | 13.48 | 5.1 |
| Methadone Placebo | 30 | 13.12 | 5.9 |
| Buprenorphine CBD | 8 | 13.38 | 7.3 |
| Buprenorphine Placebo | 6 | 12.20 | 2.9 |
| Methadone CBD | 32 | 12.37 | 3.2 |
| Methadone Placebo | 30 | 13.46 | 6.8 |
| Buprenorphine CBD | 8 | 10.60 | 0.9 |
| Buprenorphine Placebo | 6 | 13.60 | 5.0 |
| Methadone CBD | 32 | 14.14 | 5.6 |
| Methadone Placebo | 30 | 13.58 | 8.0 |
| Buprenorphine CBD | 8 | 11.00 | 1.7 |
| Buprenorphine Placebo | 6 | 14.20 | 6.3 |
| Methadone CBD | 32 | 12.07 | 3.2 |
| Methadone Placebo | 30 | 13.83 | 8.6 |
| Buprenorphine CBD | 8 | 10.20 | 0.4 |
| Buprenorphine Placebo | 6 | 13.40 | 7.1 |
| Methadone CBD | 32 | 12.78 | 4.4 |
| Methadone Placebo | 30 | 13.25 | 8.2 |
| Buprenorphine CBD | 8 | 10.40 | 0.9 |
| Buprenorphine Placebo | 6 | 13.20 | 6.6 |
Heart rate (beats/min) will be monitored throughout the time course of the study and change at Week 8 from baseline will be studied.
Population: Results provide for participants with data for both timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 27 | -0.70 | 11.8 |
| Methadone Placebo | 25 | 0.52 | 9.7 |
| Buprenorphine CBD | 6 | -4.67 | 11.5 |
| Buprenorphine Placebo | 5 | -6.20 | 10.8 |
Blood pressure (in mmHg) will be monitored throughout the time course of the study and changes at week 8 as compared from baseline will be studied. Both diastolic and systolic pressures will be assessed.
Population: Results provide for participants with data for both timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 27 | -5.33 | 19.5 |
| Methadone Placebo | 25 | 1.40 | 14.8 |
| Buprenorphine CBD | 6 | -8.83 | 13.5 |
| Buprenorphine Placebo | 5 | -1.20 | 12.2 |
| Methadone CBD | 27 | 0.81 | 14.1 |
| Methadone Placebo | 25 | 0.28 | 14.4 |
| Buprenorphine CBD | 6 | -2.00 | 14.1 |
| Buprenorphine Placebo | 5 | 0.60 | 16.6 |
Body temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes at week 8 from baseline will be studied.
Population: Results provide for participants with both for specified timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 27 | -0.44 | 2.1 |
| Methadone Placebo | 25 | -0.01 | 1.0 |
| Buprenorphine CBD | 6 | 0.52 | 1.1 |
| Buprenorphine Placebo | 5 | 0.14 | 0.8 |
Oxygen level will be measured by pulse oximetry when vitals are collected. Change in oxygen level at week 8 as compared to baseline
Population: Results provide for participants with data for both timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 27 | -1.37 | 3.5 |
| Methadone Placebo | 25 | -0.24 | 3.5 |
| Buprenorphine CBD | 6 | 0.00 | 1.8 |
| Buprenorphine Placebo | 5 | 0.40 | 1.9 |
Study participant will chew on a cotton swab providing a saliva sample from which free cortisol levels will be measured as an indicator of stress response in association with video cues. Thus, the stress of craving will be monitored and measured to observe any neutral cue induced changes from between baseline and 4 weeks, and between 4 weeks and 8 weeks.
Average sleep duration measured across 8 weeks.
Population: Results provide for participants who provided data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 15 | 359.87 | 108.19 |
| Methadone Placebo | 9 | 378.23 | 57.47 |
| Buprenorphine CBD | 4 | 412.7 | 55.44 |
| Buprenorphine Placebo | 2 | 397.76 | 205.26 |
A 5-10 minute, 7 question self-administered screening tool for insomnia. Each item rates the nature and symptoms of potential sleep problems using a 5-point Likert-type scale. Minimum score of 0 and maximum score of 28, with the highest score indicating prevalence and severity of insomnia.
Population: Results provide for participants with data for both timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 26 | -2.96 | 5.7 |
| Methadone Placebo | 25 | -3.28 | 4.2 |
| Buprenorphine CBD | 6 | -5.33 | 9.6 |
| Buprenorphine Placebo | 3 | -4.33 | 5.1 |
A 10-15 minute 30-item assessment that includes Digit Span Forward (DSF) and Digit Span Backward (DSB). DSF measures short-term memory, not working memory. DSB measures auditory working memory. Full scale from a minimum score of 0 and maximum score of 30, with the highest score indicating the total number of points achieved for correct responses.
Population: Results provide for participants with data for both timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 23 | 0.09 | 2.3 |
| Methadone Placebo | 24 | 0.29 | 2.0 |
| Buprenorphine CBD | 5 | 1.00 | 2.0 |
| Buprenorphine Placebo | 5 | -0.40 | 3.6 |
The Symptom Check List 90 (SCL-90): A 12-15 minute, 90 item self-administered psychometric instrument yielding nine scores of primary symptom dimensions (5-point rating scale; 1= Not at all, 5= Extremely), along with three scores based on global distress measures. Full scale ranges from a minimum score of 90 and maximum score of 450, with higher scores indicating more severe psychological distress.
Population: Results provide for participants with data for both timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 27 | -10.11 | 33.7 |
| Methadone Placebo | 25 | -17.08 | 36.1 |
| Buprenorphine CBD | 6 | -51.33 | 65.3 |
| Buprenorphine Placebo | 5 | -8.60 | 37.3 |
Change in percentage of participants with THC positive in Urine - Substance use other than opioids measured in urine.
Population: Results provide for participants with data for specified timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 29 | 52 | - |
| Methadone Placebo | 26 | 0 | - |
| Buprenorphine CBD | 8 | 50 | - |
| Buprenorphine Placebo | 5 | -27 | - |
| Methadone CBD | 29 | -7 | - |
| Methadone Placebo | 26 | 38 | - |
| Buprenorphine CBD | 8 | 0 | - |
| Buprenorphine Placebo | 5 | 60 | - |
Change in plasma level THC Positive in - Substance use other than opioids measured in blood.
Population: Results provide for participants with data for specified timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 26 | 1.82 | 10.6 |
| Methadone Placebo | 21 | 8.34 | 37.6 |
| Buprenorphine CBD | 6 | 0.13 | 1.2 |
| Buprenorphine Placebo | 5 | 6.30 | 17.9 |
| Methadone CBD | 26 | 6.61 | 34.3 |
| Methadone Placebo | 21 | -7.07 | 39.6 |
| Buprenorphine CBD | 6 | 0.00 | 0.0 |
| Buprenorphine Placebo | 5 | 2.08 | 3.0 |
Concentration of methadone metabolites measured in blood.
Population: Results provide for participants with data for specified timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 26 | -59.50 | 251.0 |
| Methadone Placebo | 21 | 59.36 | 300.8 |
| Methadone CBD | 26 | -18.41 | 322.6 |
| Methadone Placebo | 21 | -155.14 | 313.2 |
Concentration of buprenorphine metabolites measured in blood.
Population: Results provide for participants with data for specified timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Buprenorphine CBD | 6 | 0.20 | 2.2 |
| Buprenorphine Placebo | 5 | 1.45 | 2.8 |
| Buprenorphine CBD | 6 | -0.97 | 1.5 |
| Buprenorphine Placebo | 5 | -0.79 | 3.8 |
Retention in treatment as measured by number of participants remaining in treatment.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 32 | 28 | - |
| Methadone Placebo | 30 | 26 | - |
| Buprenorphine CBD | 8 | 8 | - |
| Buprenorphine Placebo | 6 | 5 | - |
Change in the methadone dosage at Week 8 as compared to baseline.
Population: Results provide for participants with data for both timepoints.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 27 | 3.37 | 8.5 |
| Methadone Placebo | 25 | 2.40 | 9.3 |
The number of CBD-COOH positive blood toxicology to measure adherence
Population: Data for participants who provided blood specimen
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Methadone CBD | 26 | 25 | - |
| Methadone Placebo | 22 | 0 | - |
| Buprenorphine CBD | 6 | 6 | - |
| Buprenorphine Placebo | 5 | 1 | - |
| Milestone | Methadone CBD 200mg, Then CBD 400mg | Methadone Placebo, Then CBD 400mg | Buprenorphine CBD 200mg, Then CBD 400mg | Buprenorphine Placebo, Then CBD 400mg |
|---|---|---|---|---|
| STARTED | 32 | 30 | 8 | 6 |
| COMPLETED | 29 | 26 | 8 | 5 |
| NOT COMPLETED | 3 | 4 | 0 | 1 |
| Milestone | Methadone CBD 200mg, Then CBD 400mg | Methadone Placebo, Then CBD 400mg | Buprenorphine CBD 200mg, Then CBD 400mg | Buprenorphine Placebo, Then CBD 400mg |
|---|---|---|---|---|
| STARTED | 29 | 26 | 8 | 5 |
| COMPLETED | 28 | 26 | 7 | 5 |
| NOT COMPLETED | 1 | 0 | 1 | 0 |
| Milestone | Methadone CBD 200mg, Then CBD 400mg | Methadone Placebo, Then CBD 400mg | Buprenorphine CBD 200mg, Then CBD 400mg | Buprenorphine Placebo, Then CBD 400mg |
|---|---|---|---|---|
| STARTED | 28 | 26 | 7 | 5 |
| COMPLETED | 27 | 26 | 7 | 5 |
| NOT COMPLETED | 1 | 0 | 0 | 0 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Methadone CBD 200mg: 2 / 32 · Methadone Placebo: 3 / 30 · Methadone CBD 400mg: 12 / 55 · Buprenorphine CBD 200mg: 1 / 8 · Buprenorphine Placebo: 2 / 6 · Buprenorphine CBD 400mg: 1 / 13 |
| Diarrhea | Gastrointestinal disorders | Methadone CBD 200mg: 3 / 32 · Methadone Placebo: 5 / 30 · Methadone CBD 400mg: 6 / 55 · Buprenorphine CBD 200mg: 1 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 1 / 13 |
| Fatigue | General disorders | Methadone CBD 200mg: 4 / 32 · Methadone Placebo: 2 / 30 · Methadone CBD 400mg: 6 / 55 · Buprenorphine CBD 200mg: 2 / 8 · Buprenorphine Placebo: 1 / 6 · Buprenorphine CBD 400mg: 4 / 13 |
| Headache | Nervous system disorders | Methadone CBD 200mg: 0 / 32 · Methadone Placebo: 1 / 30 · Methadone CBD 400mg: 2 / 55 · Buprenorphine CBD 200mg: 1 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
| Increased appetite | Gastrointestinal disorders | Methadone CBD 200mg: 0 / 32 · Methadone Placebo: 0 / 30 · Methadone CBD 400mg: 1 / 55 · Buprenorphine CBD 200mg: 0 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
| Insomnia | Nervous system disorders | Methadone CBD 200mg: 0 / 32 · Methadone Placebo: 0 / 30 · Methadone CBD 400mg: 1 / 55 · Buprenorphine CBD 200mg: 0 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
| Nausea | Gastrointestinal disorders | Methadone CBD 200mg: 0 / 32 · Methadone Placebo: 3 / 30 · Methadone CBD 400mg: 0 / 55 · Buprenorphine CBD 200mg: 0 / 8 · Buprenorphine Placebo: 1 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
| Rash | Skin and subcutaneous tissue disorders | Methadone CBD 200mg: 0 / 32 · Methadone Placebo: 0 / 30 · Methadone CBD 400mg: 1 / 55 · Buprenorphine CBD 200mg: 0 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
| Vomiting | Gastrointestinal disorders | Methadone CBD 200mg: 0 / 32 · Methadone Placebo: 1 / 30 · Methadone CBD 400mg: 1 / 55 · Buprenorphine CBD 200mg: 0 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
| Abdominal Discomfort | Gastrointestinal disorders | Methadone CBD 200mg: 1 / 32 · Methadone Placebo: 0 / 30 · Methadone CBD 400mg: 0 / 55 · Buprenorphine CBD 200mg: 0 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
| Constipation | Gastrointestinal disorders | Methadone CBD 200mg: 1 / 32 · Methadone Placebo: 0 / 30 · Methadone CBD 400mg: 1 / 55 · Buprenorphine CBD 200mg: 0 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
| Dry Eyes | Eye disorders | Methadone CBD 200mg: 0 / 32 · Methadone Placebo: 1 / 30 · Methadone CBD 400mg: 0 / 55 · Buprenorphine CBD 200mg: 0 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
| Dry Mouth | Gastrointestinal disorders | Methadone CBD 200mg: 0 / 32 · Methadone Placebo: 2 / 30 · Methadone CBD 400mg: 1 / 55 · Buprenorphine CBD 200mg: 0 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
| Fever | General disorders | Methadone CBD 200mg: 0 / 32 · Methadone Placebo: 0 / 30 · Methadone CBD 400mg: 1 / 55 · Buprenorphine CBD 200mg: 0 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
| Flatulence | Gastrointestinal disorders | Methadone CBD 200mg: 0 / 32 · Methadone Placebo: 0 / 30 · Methadone CBD 400mg: 3 / 55 · Buprenorphine CBD 200mg: 0 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
| Nightmares | Nervous system disorders | Methadone CBD 200mg: 0 / 32 · Methadone Placebo: 3 / 30 · Methadone CBD 400mg: 2 / 55 · Buprenorphine CBD 200mg: 0 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
| Loose Stool | Gastrointestinal disorders | Methadone CBD 200mg: 1 / 32 · Methadone Placebo: 0 / 30 · Methadone CBD 400mg: 0 / 55 · Buprenorphine CBD 200mg: 0 / 8 · Buprenorphine Placebo: 0 / 6 · Buprenorphine CBD 400mg: 0 / 13 |
Time frame: baseline and 4-weeks, 4-weeks and 8-weeks
The Questionnaire Type 9 for Depression (PHQ-9) measures depression severity with the nine DSM-IV criteria scored as "0" (not at all) to "3" (nearly every day). Full scale ranges from 0-27, with higher score indicating more severe symptoms.
Time frame: baseline, 4-weeks and 8-weeks, post-cue collected within 10 minutes of pre-cue
A 20 item self-administered questionnaire evaluating current positive and negative affect. Each item is rated on a 5-point scale (0= Very slightly or not at all, 5= Extremely). Scores range from 10 - 50 for both sets of items. For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect.
Time frame: baseline and 8-weeks
Heart rate (beats/min) will be monitored throughout the time course of the study and change at Week 8 from baseline will be studied.
Time frame: baseline and 8-weeks
Blood pressure (in mmHg) will be monitored throughout the time course of the study and changes at week 8 as compared from baseline will be studied. Both diastolic and systolic pressures will be assessed.
Time frame: baseline and 8-weeks
Body temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes at week 8 from baseline will be studied.
Time frame: baseline and 8-weeks
Oxygen level will be measured by pulse oximetry when vitals are collected. Change in oxygen level at week 8 as compared to baseline
Time frame: Baseline and 4-weeks, 4-weeks and 8-weeks
Study participant will chew on a cotton swab providing a saliva sample from which free cortisol levels will be measured as an indicator of stress response in association with video cues. Thus, the stress of craving will be monitored and measured to observe any neutral cue induced changes from between baseline and 4 weeks, and between 4 weeks and 8 weeks.
Time frame: up to 8-weeks
Average sleep duration measured across 8 weeks.
Time frame: baseline and 8-weeks
A 5-10 minute, 7 question self-administered screening tool for insomnia. Each item rates the nature and symptoms of potential sleep problems using a 5-point Likert-type scale. Minimum score of 0 and maximum score of 28, with the highest score indicating prevalence and severity of insomnia.
Time frame: baseline and 8-weeks
A 10-15 minute 30-item assessment that includes Digit Span Forward (DSF) and Digit Span Backward (DSB). DSF measures short-term memory, not working memory. DSB measures auditory working memory. Full scale from a minimum score of 0 and maximum score of 30, with the highest score indicating the total number of points achieved for correct responses.
Time frame: baseline and 8-weeks
The Symptom Check List 90 (SCL-90): A 12-15 minute, 90 item self-administered psychometric instrument yielding nine scores of primary symptom dimensions (5-point rating scale; 1= Not at all, 5= Extremely), along with three scores based on global distress measures. Full scale ranges from a minimum score of 90 and maximum score of 450, with higher scores indicating more severe psychological distress.
Time frame: baseline and 4-weeks, 4-weeks and 8 weeks
Change in percentage of participants with THC positive in Urine - Substance use other than opioids measured in urine.
Time frame: baseline and 4-weeks, 4-weeks and 8 weeks
Change in plasma level THC Positive in - Substance use other than opioids measured in blood.
Time frame: baseline and 4-weeks, 4-weeks and 8-weeks
Concentration of methadone metabolites measured in blood.
Time frame: baseline and 4-weeks, 4-weeks and 8 weeks
Concentration of buprenorphine metabolites measured in blood.
Time frame: up to 8 weeks
Retention in treatment as measured by number of participants remaining in treatment.
Time frame: baseline and 8 weeks
Change in the methadone dosage at Week 8 as compared to baseline.
Time frame: 4 weeks
The number of CBD-COOH positive blood toxicology to measure adherence