Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 31, 2026

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

Conditions
Opioid Use Disorder
Interventions
DRUG

Dronabinol Capsules

Dronabinol is a synthetic form of THC. Dronabinol is eliminated in a biphasic manner, with an initial half-life of 25-36 hours.

DRUG

Epidiolex 100 mg/mL Oral Solution

Epidiolex is an oral solution (100 mg/mL) which rapidly appears in plasma, reaches peak plasma concentration in 3-4 hours and has a half-life of 18-32 hours.

OTHER

Placebo Dronabinol

Placebo capsules

OTHER

Placebo Epidiolex

Placebo oral solution

Trial Locations (1)

10467

Montefiore Health System (Montefiore) Buprenorphine Treatment Network, The Bronx

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Montefiore Medical Center

OTHER