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RECRUITING
NCT04025359
EARLY_PHASE1

Effects of Dronabinol in Opioid Maintained Patients

Sponsor: Yale University

View on ClinicalTrials.gov

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

DRUG

Dronabinol

Dronabinol 2.5 mg

DRUG

Dronabinol

Dronabinol 5 mg

DRUG

Placebo

Placebo

Locations (1)

VA Connecticut Healthcare System

West Haven, Connecticut, United States