Cannabidiol in Opioid Use Disorder and Chronic Pain

Chronic Pain Clinical Trial

Official title: Cannabidiol Pharmacotherapy for Co-occurring Opioid Use Disorder and Chronic Pain

Status Recruiting

Clinical Trial Summary

This is a double-blind, randomized, placebo-controlled cross-over human laboratory study with a duration of approximately 3 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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Chronic Pain
• Opioid-Related Disorders

• NCT number: NCT04587791
• Study type: Interventional
• Source: Yale University
• Contact: Joao De Aquino, M.D.
• Phone: 203-5711
• Email: joao.dequino@yale.edu
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 8, 2021
• Completion date: March 30, 2025