A Phase 2 interventional study of Placebo and Cannabidiol (CBD) 200mg in Opioid Use Disorder, sponsored by Yasmin Hurd. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Yasmin Hurd · Phase 2, Interventional, and Treatment
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.
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 76 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Yasmin Hurd is the lead sponsor of 3 studies on the registry; none are open to participants now.
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An individual who meets all of the following criteria will be eligible for study participation:
Current opioid agonist maintenance treatment in an opioid treatment program with methadone or buprenorphine for at least 14 days prior to study participation. With the following more specific criteria for each of these two medications:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation:
Have a medical condition that would make study participation unsafe, which would make treatment compliance difficult, or would prevent adherence to study procedure. This includes, but is not limited to the following criteria:
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Drug: Cannabidiol (CBD) 200mg · Drug: Cannabidiol (CBD) 400mg
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Drug: Placebo · Drug: Cannabidiol (CBD) 400mg
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Drug: Cannabidiol (CBD) 200mg · Drug: Cannabidiol (CBD) 400mg
Matching placebo.in first dosing period and CBD 400mg in second dosing period
Drug: Placebo · Drug: Cannabidiol (CBD) 400mg
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.
Change in Visual Analog Scale for Craving (VASC)
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
Change in Visual Analog Scale Anxiety (VASA)
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: Baseline and 4-weeks
Percentage of Participants With Positive Urine Toxicology
Percentage of participants with positive urine toxicology for illicit opioid use at 4 weeks.
Time frame: 4-weeks
Systematic Assessment for Treatment Emergent Events (SAFTEE)
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.
Time frame: weekly for 8 weeks (Baseline, Week 1, 2, 3, 4, 5, 6, 7, and 8)
Change in Visual Analog Scale for Craving (VASC)
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
Change in Visual Analog Scale Anxiety (VASA)
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
Change in Percentage of Participants With Positive Urine Toxicology
Proportion of percentage with positive urine toxicology for illicit opioid use at 8 weeks as compared to 4 weeks.
Time frame: 4 weeks and 8 weeks
Change in Heroin Craving Questionnaire Short Form (HCQ-SF-14)
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
Change in Generalized Anxiety Disorder Scale (GAD-7)
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: Baseline and 4-weeks, 4-weeks and 8-weeks
Duration of Participant First Illicit Opioid Abstinence
Time frame: any time during study, 8 weeks
Change in Patient Health Questionnaire (PHQ-9)
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 and 4-weeks, 4-weeks and 8-weeks
Positive and Negative Affect Schedule (PANAS-SF)
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, 4-weeks and 8-weeks, post-cue collected within 10 minutes of pre-cue
Change in Heart Rate
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
Change in Blood Pressure
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
Change in Body Temperature
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
Change in Oxygen Level
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 8-weeks
Change in Cue-induced Salivary Cortisol Levels
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: Baseline and 4-weeks, 4-weeks and 8-weeks
Sleep Duration in Minutes Per Night
Average sleep duration measured across 8 weeks.
Time frame: up to 8-weeks
Change in Insomnia Severity Index (ISI)
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
Change in The Digit Span Test Subtest of the Wechsler Adult Intelligence Scale 4th Edition
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
Change in The Symptom Check List 90 (SCL-90)
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 8-weeks
Change in Percentage of Participants With THC Positive in Urine.
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 of THC Positive in Blood.
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
Change in Concentration of Methadone Metabolites in Blood
Concentration of methadone metabolites measured in blood.
Time frame: baseline and 4-weeks, 4-weeks and 8-weeks
Change in Concentration of Buprenorphine Metabolites in Blood
Concentration of buprenorphine metabolites measured in blood.
Time frame: baseline and 4-weeks, 4-weeks and 8 weeks
Number of Participants Remaining in Treatment
Retention in treatment as measured by number of participants remaining in treatment.
Time frame: up to 8 weeks
Change Methadone Dosage of Opioid Agonist Treatment
Change in the methadone dosage at Week 8 as compared to baseline.
Time frame: baseline and 8 weeks
Number of CBD-COOH Positive Blood Toxicology
The number of CBD-COOH positive blood toxicology to measure adherence
Time frame: 4 weeks
| 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 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 3 | 2 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 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 | 29 | 26 | 8 | 5 |
| Completed | 28 | 26 | 7 | 5 |
| Not completed | 1 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 |
| Withdrew: Pregnancy | 0 | 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 |
| Withdrew: Withdrawal by subject | 1 | 0 | 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 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.
| score on a scale | Methadone CBD 200mg, Then CBD 400mg | Methadone Placebo, Then CBD 400mg | Buprenorphine CBD 200mg, Then CBD 400mg | Buprenorphine Placebo, Then CBD 400mg |
|---|---|---|---|---|
| Change in VASC in response to neutral cue | 0.54 ± 1.8 | 0.31 ± 1.6 | 0.25 ± 0.5 | -0.20 ± 0.8 |
| Change in VASC in response to drug cue | 0.07 ± 2.2 | 0.04 ± 1.1 | 0.13 ± 1.0 | -1.20 ± 3.3 |
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.
| score on a scale | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Change in VASA in response to neutral cue | 0.82 ± 1.9 | 0.00 ± 1.3 | 1.25 ± 1.7 | 0.60 ± 1.8 |
| Change in VASA in response to drug cue | -0.48 ± 2.8 | 0.25 ± 1.4 | 1.00 ± 1.7 | 0.80 ± 5.2 |
Percentage of participants with positive urine toxicology for illicit opioid use at 4 weeks.
| Percentage of participants | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Percentage of Participants With Positive Urine Toxicology | 75.90 | 80.80 | 12.5 | 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.
| score on a scale | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Baseline | 0.03 ± 0.2 | 0.03 ± 0.2 | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Week 1 | 0.16 ± 0.5 | 0.39 ± 0.8 | 0.25 ± 0.5 | 0.50 ± 0.8 |
| Week 2 | 0.07 ± 0.4 | 0.11 ± 0.3 | 0.13 ± 0.4 | 0.20 ± 0.4 |
| Week 3 | 0.00 ± 0.00 | 0.08 ± 0.3 | 0.00 ± 0.0 | 0.00 ± 0.0 |
| Week 4 | 0.03 ± 0.2 | 0.04 ± 0.2 | 0.00 ± 0.0 | 0.00 ± 0.0 |
| Week 5 | 0.31 ± 0.6 | 0.46 ± 0.9 | 0.13 ± 0.4 | 0.00 ± 0.0 |
| Week 6 | 0.14 ± 0.4 | 0.15 ± 0.5 | 0.38 ± 0.5 | 0.00 ± 0.0 |
| Week 7 | 0.00 ± 0.0 | 0.04 ± 0.2 | 0.13 ± 0.5 | 0.20 ± 0.4 |
| Week 8 | 0.11 ± 0.4 | 0.19 ± 0.5 | 0.13 ± 0.4 | 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.
| score on a scale | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Change in VASC in response to neutral cue | 0.37 ± 1.3 | -0.08 ± 0.8 | 0.00 ± 0.0 | 0.40 ± 0.5 |
| Change in VASC in response to drug cue | -0.59 ± 2.1 | -0.21 ± 0.9 | -0.40 ± 0.9 | -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.
| score on a scale | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Change in VASA in response to neutral cue | 0.22 ± 1.8 | 0.04 ± 1.5 | -1.00 ± 2.2 | 1.60 ± 2.7 |
| Change in VASA in response to drug cue | -0.48 ± 2.8 | 0.25 ± 1.4 | 1.00 ± 1.7 | 0.80 ± 5.2 |
Proportion of percentage with positive urine toxicology for illicit opioid use at 8 weeks as compared to 4 weeks.
| Percentage of participants | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Change in Percentage of Participants With Positive Urine Toxicology | -4.5 | -3.9 | 25 | -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.
| score on a scale | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| between baseline and week 4 | -0.24 ± 1.1 | -0.26 ± 0.8 | -0.48 ± 0.7 | -0.60 ± 0.3 |
| between week 4 and week 8 | -0.11 ± 0.8 | -0.20 ± 0.7 | -0.11 ± 0.5 | 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.
| score on a scale | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| between baseline and wee 4 | 0.00 ± 4.5 | -1.42 ± 2.8 | -3.38 ± 4.7 | -2.40 ± 2.3 |
| between week 4 and week 8 | -1.41 ± 3.5 | -0.32 ± 2.8 | -0.33 ± 2.6 | 2.80 ± 3.7 |
| weeks | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Duration of Participant First Illicit Opioid Abstinence | 6.48 ± 2.5 | 6.26 ± 2.5 | 8.00 ± NA | 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.
| score on a scale | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| between baseline and week 4 | -1.21 ± 4.9 | -1.42 ± 4.5 | -3.13 ± 4.1 | -2.40 ± 3.0 |
| between week 4 and week 8 | -2.52 ± 5.5 | -0.72 ± 3.6 | -0.50 ± 1.5 | 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.
| score on a scale | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| baseline positive pre cue first session | 29.90 ± 8.6 | 28.77 ± 8.8 | 33.38 ± 10.5 | 25.17 ± 11.8 |
| baseline positive post cue first session | 29.44 ± 9.6 | 28.03 ± 8.8 | 32.13 ± 8.7 | 23.00 ± 13.5 |
| Baseline positive pre cue second session | 28.31 ± 9.3 | 28.90 ± 9.7 | 30.50 ± 9.5 | 21.00 ± 13.1 |
| Baseline positive post cue second session | 28.56 ± 10.1 | 27.20 ± 9.8 | 31.13 ± 12.6 | 22.33 ± 15.0 |
| Week 4 positive pre cue first session | 29.52 ± 7.7 | 31.31 ± 9.2 | 32.13 ± 14.1 | 26.60 ± 14.7 |
| Week 4 positive post cue first session | 28.34 ± 7.9 | 29.77 ± 9.9 | 32.50 ± 14.0 | 23.00 ± 14.7 |
| Week 4 positive pre cue second session | 28.07 ± 7.9 | 30.00 ± 9.3 | 31.50 ± 13.9 | 22.40 ± 15.9 |
| Week 4 positive post cue second session | 28.10 ± 9.5 | 29.65 ± 9.7 | 30.88 ± 14.5 | 22.00 ± 16.3 |
| Week 8 positive pre cue first session | 29.00 ± 9.1 | 28.46 ± 11.2 | 38.60 ± 7.4 | 23.80 ± 13.3 |
| Week 8 positive post cue first session | 28.22 ± 9.3 | 25.79 ± 12.3 | 31.00 ± 6.9 | 24.20 ± 13.7 |
| Week 8 positive pre cue second session | 28.67 ± 10.3 | 27.17 ± 12.3 | 34.60 ± 7.5 | 22.60 ± 15.1 |
| Week 8 positive post cue second session | 27.04 ± 10.5 | 28.21 ± 12.4 | 34.20 ± 7.4 | 22.20 ± 14.7 |
| Baseline negative pre cue first session | 14.48 ± 4.6 | 13.53 ± 4.8 | 14.88 ± 4.6 | 10.67 ± 0.8 |
| Baseline negative post cue first session | 14.25 ± 5.1 | 13.07 ± 3.8 | 13.63 ± 2.4 | 13.17 ± 6.8 |
| Baseline negative pre cue second session | 13.06 ± 3.8 | 12.23 ± 3.7 | 11.38 ± 1.3 | 10.67 ± 0.8 |
| Baseline negative post cue second session | 14.66 ± 4.3 | 12.13 ± 3.1 | 11.38 ± 1.9 | 11.67 ± 2.4 |
| Week 4 negative pre cue first session | 13.21 ± 4.8 | 13.38 ± 6.2 | 15.50 ± 9.4 | 11.20 ± 2.2 |
| Week 4 negative post cue first session | 13.66 ± 5.2 | 13.12 ± 5.7 | 14.13 ± 7.8 | 11.40 ± 1.9 |
| Week 4 negative pre cue second session | 12.21 ± 3.8 | 12.31 ± 5.5 | 13.25 ± 6.5 | 10.60 ± 0.9 |
| Week 4 negative post cue second session | 13.48 ± 5.1 | 13.12 ± 5.9 | 13.38 ± 7.3 | 12.20 ± 2.9 |
| Week 8 negative pre cue first session | 12.37 ± 3.2 | 13.46 ± 6.8 | 10.60 ± 0.9 | 13.60 ± 5.0 |
| Week 8 negative post cue first session | 14.14 ± 5.6 | 13.58 ± 8.0 | 11.00 ± 1.7 | 14.20 ± 6.3 |
| Week 8 negative pre cue second session | 12.07 ± 3.2 | 13.83 ± 8.6 | 10.20 ± 0.4 | 13.40 ± 7.1 |
| Week 8 negative post cue second session | 12.78 ± 4.4 | 13.25 ± 8.2 | 10.40 ± 0.9 | 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.
| beats per min | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Change in Heart Rate | -0.70 ± 11.8 | 0.52 ± 9.7 | -4.67 ± 11.5 | -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.
| mmHg | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| systolic | -5.33 ± 19.5 | 1.40 ± 14.8 | -8.83 ± 13.5 | -1.20 ± 12.2 |
| diastolic | 0.81 ± 14.1 | 0.28 ± 14.4 | -2.00 ± 14.1 | 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.
| degrees in Fahrenheit | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Change in Body Temperature | -0.44 ± 2.1 | -0.01 ± 1.0 | 0.52 ± 1.1 | 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
| percentage of SP02 | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Change in Oxygen Level | -1.37 ± 3.5 | -0.24 ± 3.5 | 0.00 ± 1.8 | 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.
Results for this outcome have not been posted.
Average sleep duration measured across 8 weeks.
| minutes per night | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Sleep Duration in Minutes Per Night | 359.87 ± 108.19 | 378.23 ± 57.47 | 412.7 ± 55.44 | 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.
| score on a scale | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Change in Insomnia Severity Index (ISI) | -2.96 ± 5.7 | -3.28 ± 4.2 | -5.33 ± 9.6 | -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.
| score on a scale | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Change in The Digit Span Test Subtest of the Wechsler Adult Intelligence Scale 4th Edition | 0.09 ± 2.3 | 0.29 ± 2.0 | 1.00 ± 2.0 | -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.
| score on a scale | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Change in The Symptom Check List 90 (SCL-90) | -10.11 ± 33.7 | -17.08 ± 36.1 | -51.33 ± 65.3 | -8.60 ± 37.3 |
Change in percentage of participants with THC positive in Urine - Substance use other than opioids measured in urine.
| Percentage of participants | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| baseline and week 4 | 52 | 0 | 50 | -27 |
| week 4 and week 8 | -7 | 38 | 0 | 60 |
Change in plasma level THC Positive in - Substance use other than opioids measured in blood.
| ng/ml | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| between baseline and week 4 | 1.82 ± 10.6 | 8.34 ± 37.6 | 0.13 ± 1.2 | 6.30 ± 17.9 |
| between week 4 and week 8 | 6.61 ± 34.3 | -7.07 ± 39.6 | 0.00 ± 0.0 | 2.08 ± 3.0 |
Concentration of methadone metabolites measured in blood.
| ng/ml | Methadone CBD | Methadone Placebo |
|---|---|---|
| between baseline and week 4 | -59.50 ± 251.0 | 59.36 ± 300.8 |
| between week 4 and week 8 | -18.41 ± 322.6 | -155.14 ± 313.2 |
Concentration of buprenorphine metabolites measured in blood.
| ng/ml | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|
| between baseline and week 4 | 0.20 ± 2.2 | 1.45 ± 2.8 |
| between week 4 and week 8 | -0.97 ± 1.5 | -0.79 ± 3.8 |
Retention in treatment as measured by number of participants remaining in treatment.
| Participants | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Number of Participants Remaining in Treatment | 28 | 26 | 8 | 5 |
Change in the methadone dosage at Week 8 as compared to baseline.
| mg | Methadone CBD | Methadone Placebo |
|---|---|---|
| Change Methadone Dosage of Opioid Agonist Treatment | 3.37 ± 8.5 | 2.40 ± 9.3 |
The number of CBD-COOH positive blood toxicology to measure adherence
| Participants | Methadone CBD | Methadone Placebo | Buprenorphine CBD | Buprenorphine Placebo |
|---|---|---|---|---|
| Number of CBD-COOH Positive Blood Toxicology | 25 | 0 | 6 | 1 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Methadone CBD 200mg | 0/32 (0%) | 0/32 (0%) | 12/32 (37.5%) |
| Methadone Placebo | 0/30 (0%) | 0/30 (0%) | 21/30 (70%) |
| Methadone CBD 400mg | 0/55 (0%) | 0/55 (0%) | 38/55 (69.1%) |
| Buprenorphine CBD 200mg | 0/8 (0%) | 0/8 (0%) | 5/8 (62.5%) |
| Buprenorphine Placebo | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Buprenorphine CBD 400mg | 0/13 (0%) | 0/13 (0%) | 6/13 (46.2%) |
| Event | Methadone CBD 200mg | Methadone Placebo | Methadone CBD 400mg | Buprenorphine CBD 200mg | Buprenorphine Placebo | Buprenorphine CBD 400mg |
|---|---|---|---|---|---|---|
| Abdominal PainGastrointestinal disorders | 2/32 | 3/30 | 12/55 | 1/8 | 2/6 | 1/13 |
| FatigueGeneral disorders | 4/32 | 2/30 | 6/55 | 2/8 | 1/6 | 4/13 |
| DiarrheaGastrointestinal disorders | 3/32 | 5/30 | 6/55 | 1/8 | 0/6 | 1/13 |
| NauseaGastrointestinal disorders | 0/32 | 3/30 | 0/55 | 0/8 | 1/6 | 0/13 |
| HeadacheNervous system disorders | 0/32 | 1/30 | 2/55 | 1/8 | 0/6 | 0/13 |
| NightmaresNervous system disorders | 0/32 | 3/30 | 2/55 | 0/8 | 0/6 | 0/13 |
| Dry MouthGastrointestinal disorders | 0/32 | 2/30 | 1/55 | 0/8 | 0/6 | 0/13 |
| FlatulenceGastrointestinal disorders | 0/32 | 0/30 | 3/55 | 0/8 | 0/6 | 0/13 |
| VomitingGastrointestinal disorders | 0/32 | 1/30 | 1/55 | 0/8 | 0/6 | 0/13 |
| Dry EyesEye disorders | 0/32 | 1/30 | 0/55 | 0/8 | 0/6 | 0/13 |
| Age, Continuous(years) | Methadone CBD 200mg, Then CBD 400mg | Methadone Placebo, Then CBD 400mg | Buprenorphine CBD 200mg, Then CBD 400mg | Buprenorphine Placebo, Then CBD 400mg | Total |
|---|---|---|---|---|---|
| Mean | 44.5 ± 10.6 | 46.63 ± 12.7 | 47.85 ± 12.3 | 45.01 ± 8.1 | 45.74 ± 11.3 |
| Sex: Female, Male(Participants) | Methadone CBD 200mg, Then CBD 400mg | Methadone Placebo, Then CBD 400mg | Buprenorphine CBD 200mg, Then CBD 400mg | Buprenorphine Placebo, Then CBD 400mg | Total |
|---|---|---|---|---|---|
| Female | 5 | 4 | 3 | 1 | 13 |
| Male | 27 | 26 | 5 | 5 | 63 |
| Ethnicity (NIH/OMB)(Participants) | Methadone CBD 200mg, Then CBD 400mg | Methadone Placebo, Then CBD 400mg | Buprenorphine CBD 200mg, Then CBD 400mg | Buprenorphine Placebo, Then CBD 400mg | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 12 | 13 | 1 | 2 | 28 |
| Not Hispanic or Latino | 20 | 17 | 7 | 4 | 48 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Methadone CBD 200mg, Then CBD 400mg | Methadone Placebo, Then CBD 400mg | Buprenorphine CBD 200mg, Then CBD 400mg | Buprenorphine Placebo, Then CBD 400mg | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 2 | 1 | 0 | 5 |
| Asian | 0 | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 8 | 11 | 3 | 2 | 24 |
| White | 12 | 10 | 2 | 1 | 25 |
| More than one race | 10 | 7 | 1 | 3 | 21 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
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Plan to share: No — It is not yet known if there will be a plan to make IPD available, if the plan changes, the research team will share the plan details.
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Yasmin Hurd