Actively Recruiting
Effects of Dronabinol in Opioid Maintained Patients
Led by Yale University · Updated on 2026-03-16
36
Participants Needed
1
Research Sites
378 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
V
VA Connecticut Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Dronabinol in Opioid Maintained Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 opioid use disorder 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 opioid use disorder or tobacco use disorder within the last 12 months.
- No current medical problems deemed contraindicated for participation by principal investigator.
- For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods.
You will not qualify if you...
- Currently meeting DSM-5 criteria for cannabis use disorder.
- History of primary psychotic disorders or other current major psychiatric disorders deemed clinically unstable by the principal investigator.
- Serious medical or neurological illness or treatment for a medical disorder that could interfere with study participation as determined by principal investigator.
- Inability to complete neuropsychological tests.
- Use of psychoactive drugs affecting pain threshold or tolerance unless doses are stable and allow study participation.
- Liver function tests (ALT or AST) greater than 3 times normal.
- Contraindications for exposure to cold temperatures, such as Raynaud's phenomenon and hypertension.
- Allergy or serious adverse reaction to cannabis, dronabinol, or other cannabinoids.
AI-Screening
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Trial Site Locations
Total: 1 location
1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Actively Recruiting
Research Team
J
Joao P. De Aquino, M.D.
CONTACT
J
Julia Meyerovich
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
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