Effects of Dronabinol on Pain in Patients Using Opioids
The Effects of Dronabinol in Opioid-Related Outcomes
EARLY_PHASE1 · Yale University · NCT04025359
This study is testing if dronabinol can help reduce pain for people with opioid use disorder who are taking methadone or buprenorphine.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 1 site (West Haven, Connecticut) |
| Trial ID | NCT04025359 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of dronabinol, a cannabinoid, on pain sensitivity in patients with opioid use disorder (OUD) who are currently receiving methadone or buprenorphine. The study involves a double-blind, randomized, placebo-controlled, cross-over design with 20 participants aged 18-70. Participants will receive either dronabinol or a placebo before their daily opioid dose, and various pain-related outcomes will be measured using quantitative sensory testing and questionnaires. The study aims to assess the impact of dronabinol on pain perception and cognitive performance in this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 diagnosed with opioid use disorder and currently stable on methadone or buprenorphine maintenance treatment.
Not a fit: Patients with current cannabis use disorder or significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to managing pain in patients with opioid use disorder, potentially reducing reliance on opioids.
How similar studies have performed: While there is limited research specifically on dronabinol in this context, studies on cannabinoids for pain management have shown promising results, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
West Haven, Connecticut
- VA Connecticut Healthcare System — West Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Joao De Aquino, M.D. — VA Healthcare System West Haven CT
- Study coordinator: Joao P. De Aquino, M.D.
- Email: joao.deaquino@va.gov
- Phone: 203-932-5711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain