Effects of Dronabinol in Opioid Maintained Patients

• Status: Recruiting
• Trial end date: 2022-01-30
• Target enrollment: 0
• Participant gender: All

Summary

Twenty male and female (ages 18-60) 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 (10, 20mg) or placebo. Subsequently, all participants will undergo laboratory testing of opioid-related outcomes. Pain sensitivity will be measured using the well-validated Cold Pressor Test (CPT), the 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: US Department of Veterans Affairs
• Treatments: Dronabinol

Criteria

Inclusion Criteria:

• Cannabis use, with recent cannabis exposure confirmed by urine toxicology.

• 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 Criteria:

• 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.