CBD in Opioid Use and Chronic Pain
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Pain
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: participants will receive CBD (400 mg, 800 mg, 1200 mg) or placebo.Masking: Double (Participant, Investigator)Masking Description: participants will receive CBD (400 mg, 800 mg, 1200 mg) or placebo.Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
Twenty two 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 or buprenorphine, will be enrolled. Prior to their daily methadone or buprenorphine dose and thus at trough plasma levels of o...
Twenty two 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 or buprenorphine, 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 Cold Pressor Test (CPT), Quantitative Sensory Testing (QST), the Short-Form McGill Pain Questionnaire (SF-MPQ) 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). 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). 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.
Tracking Information
- NCT #
- NCT04587791
- Collaborators
- VA Connecticut Healthcare System
- Investigators
- Principal Investigator: Mehmet Sofuoglu, M.D.,Ph.D. Yale University