Status:
RECRUITING
Effects of Dronabinol in Opioid Maintained Patients
Lead Sponsor:
Yale University
Collaborating Sponsors:
US Department of Veterans Affairs
Conditions:
Pain
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief 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 plasm...
Detailed 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 sessio...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- Currently meeting DSM-5 criteria for cannabis use disorder (CUD).
- 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.
- A physician will carefully evaluate participants for use of over-the-counter or prescription psychoactive drugs known to affect pain threshold or pain tolerance (including NSAIDS, serotonin-norepinephrine reuptake inhibitors (SNRIs), (e.g. venlafaxine, duloxetine), tricyclic antidepressants (e.g., nortriptyline, amitriptyline), anticonvulsant medications (e.g., topiramate, tegretol), benzodiazepines (e.g., alprazolam, diazepam), and other opioid drugs). Only subjects who are on stable doses of these medications, and whose dosing schedules allow participation in the study visits, will be enrolled. If possible, the morning dose will be administered after the study visit.
- Liver function tests (ALT or AST) greater than 3x 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.
Key Trial Info
Start Date :
May 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04025359
Start Date
May 31 2019
End Date
September 1 2026
Last Update
May 23 2025
Active Locations (1)
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1
VA Healthcare System
West Haven, Connecticut, United States, 06516