Recruiting
Early Phase 1

Dronabinol

Sponsor:

Yale University

Code:

NCT04025359

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Dronabinol

Dronabinol

Placebo

Study Details

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

Study ID

NCT04025359

Start date

May 31, 2019

Status verified date

Jul, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Dronabinol 2.5mg

Dronabinol 2.5mg

active comparator: Dronabinol 5mg

Dronabinol 5mg

placebo comparator: Placebo

Placebo

Interventions

Dronabinol

Dronabinol 2.5 mg

Dronabinol

Dronabinol 5 mg

Placebo

Placebo

Primary outcome measure

  • Pain sensitivity, measured by the Cold Pressor Test (CPT). [ Time Frame: up to 6 hours ]
  • Pain sensitivity, measured by the Short form of the McGill Pain Questionnaire (SF-MPQ). [ Time Frame: up to 6 hours ]

Central Contacts and Locations

Central contacts

Joao P. De Aquino, M.D.

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

Julia Meyerovich

203-932-5711

Locations

VA Connecticut Healthcare System

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

Julia Meyerovich

203-932-5711julia.meyerovich@yale.edu

Principal Investigator:

Joao P. De Aquino, M.D.

More Information

Sponsor

Yale University

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-16.