Cannabidiol in Opioid Use Disorder and Chronic Pain
- Conditions
- Chronic PainOpioid Use Disorder
- Interventions
- Drug: 400mg CannabidiolDrug: 800mg CannabidiolDrug: 1200mg CannabidiolDrug: Saline
- Registration Number
- NCT04587791
- Lead Sponsor
- Yale University
- Brief Summary
This is a double-blind, randomized, placebo-controlled cross-over human laboratory study with a duration of approximately 4 weeks, during which participants will come to the testing site for a total of five times: one initial screening session, and four experimental sessions where study medication, Cannabidiol (CBD) will be administered, separated by at least 72 hours to limit carryover effects.
- Detailed Description
Thirty-six male and female (ages 18-70) participants with comorbid opioid use disorder (OUD) and non-cancer chronic pain for at least 6 months, currently receiving methadone (n= 22) or buprenorphine (n= 12), will be enrolled. Prior to their daily methadone or buprenorphine dose and thus at trough plasma levels of opioid, participants will receive oral CBD (400 mg, 800 mg, 1200 mg) or placebo. Subsequently, all participants will undergo laboratory testing of opioid-related outcomes.
Pain sensitivity will be measures including the well-validated, Quantitative Sensory Testing (QST), the Pain Catastrophizing Scale (PCS), and a pain Visual Analog Scale (VAS). Attentional bias and cue-induced opioid craving will be measured using a visual probe task and the Heroin Craving Scale (HCQ-14). Abuse potential will be measured using the Drug Effects Questionnaire (DEQ). Negative affect will be measured using the Positive and Negative Affect Schedule (PANAS). Cognitive performance will be measured by a comprehensive cognitive battery that includes the Continuous Performance Test (CPT) and the Hopkins Verbal Learning Test (HVLT). Safety will be thoroughly measured with the Systematic Assessment for Treatment Emergent Events (SAFTEE) for adverse effects.
The order of study medication administration will be counterbalanced order to minimize carryover effects. On the initial screening day and at the end of medication treatment, blood will be drawn to determine serum drug levels. Participants will be thoroughly evaluated by a physician prior to discharge on each experimental session. One week after the last study medication dose, participants will be conducted by phone for a follow-up session.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
- Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
- Having chronic pain, uniformly operationalized as grade II (high-intensity) non-cancer musculoskeletal pain for ≥ 6 months 49
- Capable of providing informed consent in English.
- Compliant in opioid maintenance treatment and on a stable dose for two weeks or longer.
- Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months.
- No current medical problems deemed contraindicated for participation by principal investigator.
- For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods.
- Other current major psychiatric disorders deemed clinically unstable by the principal investigator, such as severe depression and/or active suicidal ideation.
- Having experienced major psychosocial stressors recently (≤ 6 weeks before enrollment), at the discretion of the principal investigator.
- Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment).
- A study physician will determine if participants receiving products containing THC or CBD products may participate in the study.
- Current use benzodiazepines or platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor).
- Current weight of less of 60 kg.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CBD 400mg 400mg Cannabidiol CBD 400 mg CBD 800mg 800mg Cannabidiol CBD 800mg CBD 1200mg 1200mg Cannabidiol CBD 1200mg Saline Saline saline
- Primary Outcome Measures
Name Time Method Primary Outcome Variable #1: Safety and tolerability of CBD Baseline and up to 6 hours To monitor adverse events from the study medications, the Systematic Assessment for Treatment Emergent Events (SAFTEE) will be administered before and after each experimental session. This is a symptom checklist that has been used successfully in our previous studies to assess possible side effects of study medications. It includes information regarding severity of any presenting side effects, as well as the course of action taken by study staff in response.
Primary Outcome Variable #2: Pain Sensitivity Baseline and up to 6 hours We will measure pain sensitivity using a comprehensive QST battery at baseline and approximately hourly for 6 hours.
Primary Outcome Variable #3: Abuse potential of CBD (DEQ) Baseline and up to 6 hours The abuse potential of CBD will be assessed using the Drug Effects Questionnaire (DEQ) administered at baseline and every 30 minutes. The primary DEQ outcome is the Stimulatory Effects subscale, obtained by averaging participants responses to the items: "Feel High"; "Feel Stimulated"; and "Feel the Drug Strength".
Primary Outcome Variable #4A: Cognitive/psychomotor effects (CPT) +210 minutes post dose The cognitive/psychomotor effects of CBD will be assessed using the Continuous Performance Test (CPT). For the CPT, the primary outcome will be the throughput score, which indexes attention/working memory accuracy (i.e. percent of correct responses) and speed (i.e. reaction time).
Primary Outcome Variable #4B: Cognitive/psychomotor effects (HVLT) +210 minutes post dose The cognitive/psychomotor effects of CBD will be assessed using the Hopkins Verbal Learning Test (HVLT). The primary outcome for the HVLT will be immediate and delayed recall, which index verbal memory.
- Secondary Outcome Measures
Name Time Method Secondary Outcome Variable #1: Opioid Craving Baseline and +150 minutes post dose We will measure opioid craving using the short form Heroin Craving Questionnaire (HCQ-14) given to participants before and after a watching a visual probe task used to induce craving.
Trial Locations
- Locations (1)
Department of Veterans Affairs Hospital
🇺🇸West Haven, Connecticut, United States