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Dronabinol for Pain Management in Opioid Users (THC Trial)

Phase < 1
Recruiting
Led By Mehmet Sofuoglu, M.D., Ph.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment
Capable of providing informed consent in English
Must not have
Contraindications for exposure to cold temperatures, such as Raynaud's phenomenon and hypertension
Inability to complete neuropsychological tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 hours

Summary

This trial will test the effects of dronabinol, a medication derived from marijuana, on people with opioid addiction who are receiving methadone or buprenorphine. The study will measure pain sensitivity, attentional bias, negative affect, and cognitive performance.

Who is the study for?
This trial is for men and women aged 18-70 with opioid use disorder (OUD) who are on stable methadone or buprenorphine treatment. Participants must not be pregnant, should use birth control, have recent cannabis exposure without a cannabis use disorder, and no major medical issues or other substance use disorders.
What is being tested?
The study tests the effects of Dronabinol versus placebo in patients maintained on opioids. It involves taking the study medication before their regular dose of methadone or buprenorphine and then undergoing pain sensitivity tests, attentional bias tasks, mood assessments, cognitive performance evaluations, and blood tests to measure cytokines.
What are the potential side effects?
Dronabinol may cause side effects such as changes in mood or perception since it's related to substances found in cannabis. Other possible side effects include dizziness, stomach discomforts like nausea or vomiting, weakness or lack of energy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently receiving methadone or buprenorphine for opioid use disorder.
Select...
I can understand and sign the consent form in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have conditions like Raynaud's or high blood pressure that worsen with cold.
Select...
I cannot complete brain function tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain sensitivity, measured by the Cold Pressor Test (CPT).
Pain sensitivity, measured by the Short form of the McGill Pain Questionnaire (SF-MPQ).
Secondary study objectives
Abuse potential, measured by the Drug Effects Questionnaire (DEQ).
Cognitive Performance, measured by the Continuous Performance Test (CPT)
Cognitive Performance, measured by the Hopkins Verbal Learning Test (HVLT).

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Dronabinol 5mgActive Control1 Intervention
Dronabinol 5mg
Group II: Dronabinol 2.5mgActive Control1 Intervention
Dronabinol 2.5mg
Group III: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

US Department of Veterans AffairsFED
875 Previous Clinical Trials
498,385 Total Patients Enrolled
13 Trials studying Pain
2,931 Patients Enrolled for Pain
Yale UniversityLead Sponsor
1,929 Previous Clinical Trials
3,032,860 Total Patients Enrolled
16 Trials studying Pain
5,114 Patients Enrolled for Pain
Mehmet Sofuoglu, M.D., Ph.D.Principal InvestigatorVA healthcare System West Haven CT
12 Previous Clinical Trials
444 Total Patients Enrolled
2 Trials studying Pain
54 Patients Enrolled for Pain
Joao De Aquino, M.D.Principal InvestigatorVA healthcare System West Haven CT
2 Previous Clinical Trials
47 Total Patients Enrolled

Media Library

Dronabinol 5mg Clinical Trial Eligibility Overview. Trial Name: NCT04025359 — Phase < 1
Pain Research Study Groups: Dronabinol 5mg, Dronabinol 2.5mg, Placebo
Pain Clinical Trial 2023: Dronabinol 5mg Highlights & Side Effects. Trial Name: NCT04025359 — Phase < 1
Dronabinol 5mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT04025359 — Phase < 1
~1 spots leftby Feb 2025
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