Effects of Dronabinol in Opioid Maintained Patients

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04025359
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dronabinol — DRUG
    Dronabinol 2.5 mg
  • Dronabinol — DRUG
    Dronabinol 5 mg
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
May 31, 2019
Status verified
Mar 2026
Primary completion
May 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Dronabinol 2.5mg
    Dronabinol 2.5mg
  • Active Comparator: Dronabinol 5mg
    Dronabinol 5mg
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

Pain sensitivity, measured by the Cold Pressor Test (CPT). [ Time Frame: up to 6 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare SystemWest HavenConnecticut06516
Julia Meyerovich
[email protected]
203-932-5711
Joao P. De Aquino, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in West Haven, CT

By research site
VA Connecticut Healthcare System· West Haven, CT

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