The Effects of Dronabinol in Opioid-Related Outcomes
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.
Description
This is a double-blind, randomized, placebo-controlled cross-over human laboratory study. Participants will be asked to come to the testing site for a total of four times: one initial screening session (\~ 3 hours) and three test days (\~ 6 hours each) where study medication will be administered, separated by at least 72 hours to limit carryover effects for dronabinol administration. Twenty male and female participants with OUD on MAT will be asked to arrive at approximately the same time each morning, coordinating with attendance at their opioid maintenance clinic. Subjects will be asked to r…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Prior exposure to THC or cannabis at least once in the last 10 years; 1-10 times in the last 20 years; or more than 20 times in their lifetime. * Males and females, Veterans and non-Veterans, aged between 18 and 70. * Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment. * 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.…
Interventions
- DrugDronabinol
Dronabinol 2.5 mg
- DrugDronabinol
Dronabinol 5 mg
- DrugPlacebo
Placebo
Location
- VA Connecticut Healthcare SystemWest Haven, Connecticut