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Study identifier: NCT04025359 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Effects of Dronabinol in Opioid Maintained Patients

Condition: Pain  ·  Sponsor: Yale University

PhaseEARLY_Phase 1
Planned participants36
Who can joinAll sexes, 18 Years to 70 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Joao P. De Aquino, M.D.  ·  203-932-5711  ·  joao.deaquino@va.gov

Julia Meyerovich  ·  203-932-5711

Always discuss trial participation with your own doctor first.

Locations (1)

VA Connecticut Healthcare SystemWest Haven, Connecticut, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04025359