Study 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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 3 Secondary · Reporting Duration: up to 6 hours
up to 3 weeks
Pain and threshold measured by the Cold Pressor Test (CPT).
up to 6 hours
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).
Pain sensitivity, measured by the Cold Pressor Test (CPT).
Pain sensitivity, measured by the Short form of the McGill Pain Questionnaire (SF-MPQ).
Trial Safety
Safety Progress
Trial Design
5 Treatment Groups
Dronabinol 20mg
1 of 5
Dronabinol 10mg
1 of 5
Dronabinol 5mg
1 of 5
Dronabinol 2.5mg
1 of 5
Placebo
1 of 5
Active Control
Non-Treatment Group
36 Total Participants · 5 Treatment Groups
Primary Treatment: Dronabinol 20mg · Has Placebo Group · Phase < 1
Dronabinol 20mg
Drug
ActiveComparator Group · 1 Intervention: Dronabinol · Intervention Types: DrugDronabinol 10mg
Drug
ActiveComparator Group · 1 Intervention: Dronabinol · Intervention Types: DrugDronabinol 5mg
Drug
ActiveComparator Group · 1 Intervention: Dronabinol · Intervention Types: DrugDronabinol 2.5mg
Drug
ActiveComparator Group · 1 Intervention: Dronabinol · Intervention Types: DrugPlaceboPlaceboComparator Group · 2 Interventions: Placebo, Placebos · Intervention Types: Drug, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 hours
Who is running the clinical trial?
US Department of Veterans AffairsFED
853 Previous Clinical Trials
470,255 Total Patients Enrolled
13 Trials studying Pain
2,931 Patients Enrolled for Pain
Yale UniversityLead Sponsor
1,680 Previous Clinical Trials
21,088,223 Total Patients Enrolled
14 Trials studying Pain
3,330 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
46 Total Patients Enrolled
Eligibility Criteria
Age 18 - 70 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have not used any substance or drugs other than alcohol or tobacco within the last 12 months.
You have been exposed to cannabis within the last 12 months.
You have a minimum age of 18 years and are male or female, veteran or non-veteran.
You are currently enrolled in methadone or buprenorphine maintenance treatment.
You are not currently suffering from any contraindicated medical condition.
You are not pregnant or breast-feeding
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Conditions
Cancer Related
Treatments