NCT04025359 Effects of Dronabinol in Opioid Maintained Patients
| NCT ID | NCT04025359 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Yale University |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2019-05-31 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2019-05-31 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Joao De Aquino, M.D.
PRINCIPAL INVESTIGATOR
VA Healthcare System West Haven CT
Frequently Asked Questions
Who can join the NCT04025359 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04025359 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04025359 currently recruiting?
Yes, NCT04025359 is actively recruiting participants. Contact the research team at joao.deaquino@va.gov for enrollment information.
Where is the NCT04025359 trial being conducted?
This trial is being conducted at West Haven, United States.
Who is sponsoring the NCT04025359 clinical trial?
NCT04025359 is sponsored by Yale University. The principal investigator is Joao De Aquino, M.D. at VA Healthcare System West Haven CT. The trial plans to enroll 36 participants.