Cannabidiol in the Treatment of Opioid Use Disorder
- Conditions
- Opioid Use Disorder
- Interventions
- Registration Number
- NCT06206291
- Lead Sponsor
- Yasmin Hurd
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 141
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methadone Placebo Placebo Matching placebo.in first dosing period and CBD 400mg in second dosing period Buprenorphine Placebo Placebo Matching placebo.in first dosing period and CBD 400mg in second dosing period Buprenorphine CBD Cannabidiol (CBD) 200mg CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. Methadone CBD Cannabidiol (CBD) 400mg CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. Methadone CBD Cannabidiol (CBD) 200mg CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. Methadone Placebo Cannabidiol (CBD) 400mg Matching placebo.in first dosing period and CBD 400mg in second dosing period Buprenorphine CBD Cannabidiol (CBD) 400mg CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. Buprenorphine Placebo Cannabidiol (CBD) 400mg Matching placebo.in first dosing period and CBD 400mg in second dosing period
- Primary Outcome Measures
Name Time Method Proportion of participants with positive urine toxicology 4-weeks Proportion of participants with positive urine toxicology for illicit opioid use at 4 weeks.
Change in Visual Analog Scale for Craving (VASC) 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.
Change in Visual Analog Scale Anxiety (VASA) 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.
Systematic Assessment for Treatment Emergent Events (SAFTEE) weekly for 8 weeks 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 Outcome Measures
Name Time Method Change in Heroin Craving Questionnaire Short Form (HCQ-SF-14) 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.
Change in Generalized Anxiety Disorder Scale (GAD-7) 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.
Duration of participant first illicit opioid abstinence any time during study, 8 weeks Change in Patient Health Questionnaire (PHQ-9) 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.
Change in Visual Analog Scale for craving (VASC) 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.
Change in Visual Analog Scale Anxiety (VASA) 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.
Change in proportion of participants with positive urine toxicology 4 weeks and 8 weeks Proportion of participants with positive urine toxicology for illicit opioid use at 8 weeks as compared to 4 weeks.
Change in Substance use other than opioids in blood 4-weeks and 8 weeks Substance use other than opioids measured in blood.
Change in Oxygen level baseline and 8-weeks Oxygen level will be measured by pulse oximetry when vitals are collected for each participant throughout the study.
Change in The Digit Span Test subtest of the Wechsler Adult Intelligence Scale 4th edition 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.
Change in Change in dosage of opioid agonist treatment baseline and 8 weeks Positive and Negative Affect Schedule (PANAS-SF) 4-weeks and 8-weeks 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.
Change in Heart rate baseline and 8-weeks Heart rate (beats/min) will be monitored throughout the time course of the study and changes from baseline will be studied.
Change in Blood pressure baseline and 8-weeks Blood pressure (in mmHg) will be monitored throughout the time course of the study and changes from baseline will be studied. Both diastolic and systolic pressures will be assessed.
Change in Body Temperature baseline and 8-weeks Body temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes from baseline will be studied.
Change in Cue-induced salivary cortisol levels 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 changes from 4-weeks.
Sleep duration up to 8-weeks Average sleep duration measured across 8 weeks.
Change in Substance use other than opioids in urine 4-weeks and 8 weeks Substance use other than opioids measured in urine.
Change in Insomnia Severity Index (ISI) 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.
Change in The Symptom Check List 90 (SCL-90) 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.
Change in Concentration of methadone or buprenorphine metabolites in urine 4-weeks and 8-weeks Concentration of methadone or buprenorphine metabolites measured in urine.
Change in Concentration of methadone or buprenorphine metabolites in blood 4-weeks and 8-weeks Concentration of methadone or buprenorphine metabolites measured in blood.
Number of participants remaining in treatment up to 8 weeks Retention in treatment
Number of positive urine toxicology 4 weeks The number of positive urine toxicology to measure adherence
Number of positive blood toxicology 4 weeks The number of positive blood toxicology to measure adherence
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States