Effects of Dronabinol in Opioid Maintained Patients

NCT04025359 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 2000027065
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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

Pain

Outcome Measures

Primary Outcomes (2)

• Pain sensitivity, measured by the Cold Pressor Test (CPT).

  Pain threshold and pain tolerance, in seconds.

  up to 6 hours

• Pain sensitivity, measured by the Short form of the McGill Pain Questionnaire (SF-MPQ).

  Subjective pain measured by the SF-MPQ. The SF-MPQ values range from 0 to 45, with higher values indicating greater pain sensitivity.

  up to 6 hours

Secondary Outcomes (4)

• Abuse potential, measured by the Drug Effects Questionnaire (DEQ).

  up to 6 hours

• Cognitive Performance, measured by the Continuous Performance Test (CPT)

  up to 6 hours

• Cognitive Performance, measured by the Hopkins Verbal Learning Test (HVLT).

  up to 6 hours

• Opioid craving measured by the Subjective Opiate Withdrawal Scale (SOWS)

  Baseline (30 minutes before the administration of dronabinol), and every 30 minutes after the administration of dronabinol (up to +210 minutes)

Study Arms (3)

Dronabinol 2.5mg

ACTIVE COMPARATOR

Dronabinol 2.5mg

Drug: Dronabinol

Dronabinol 5mg

ACTIVE COMPARATOR

Dronabinol 5mg

Drug: Dronabinol

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Dronabinol DRUG

Dronabinol 2.5 mg

Also known as: Marinol

Dronabinol 2.5mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Connecticut Healthcare System: collaborator
• Yale University: lead

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Joao De Aquino, M.D.

  VA Healthcare System West Haven CT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joao P. De Aquino, M.D.

CONTACT

203-932-5711; joao.deaquino@va.gov

Julia Meyerovich

CONTACT

203-932-5711

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study medication will be prepared by research pharmacy using over-encapsulation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 session (\~ 3 hours) and three test days (\~ 6 hours each) where study medication will be administered, separated by at least 72 hours to limit carryover effects for dronabinol administration.

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 18, 2019
• Study Start: May 31, 2019
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)