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Effects of Dronabinol in Opioid Maintained Patients
Sponsor: Yale University
Summary
Twenty male and female (ages 18-70) participants with OUD 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 dronabinol (2.5 mg, 5mg) or placebo. Subsequently, all participants will undergo laboratory testing of opioid-related outcomes. Pain sensitivity will be measured using a technique called the (QST) quantitative sensory testing, which involves the administering heat or cold stimulation. A Short-Form McGill Pain Questionnaire (SF-MPQ) and a pain Visual Analog Scale (VAS). Attentional bias will be measured using a visual probe task. Negative affect will be measured using the Positive and Negative Affect Schedule (PANAS). Cognitive performance will be measured by a comprehensive cognitive battery. 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 cytokine levels. One week after the last study medication dose, a follow-up session will be conducted during which participants will undergo urine toxicology testing and a safety evaluation before final discharge from the study.
Official title: The Effects of Dronabinol in Opioid-Related Outcomes
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2019-05-31
Completion Date
2026-09-01
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Dronabinol
Dronabinol 2.5 mg
Dronabinol
Dronabinol 5 mg
Placebo
Placebo
Locations (1)
VA Connecticut Healthcare System
West Haven, Connecticut, United States