Study to Test the Safety and Efficacy of Cannabidiol as a Treatment Intervention for Opioid Relapse

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Despite the current available therapies for opioid-dependent patients, most patients relapse. This research project focuses on the development of a novel compound, cannabidiol, to modulate opioid craving in humans based on animal models showing its selective effectiveness to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse would be of tremendous medical and public health value.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hurd,Yasmin, Ph.D.
• Treatments: Cannabidiol; Fentanyl

Criteria

Inclusion Criteria:

• being aged between 21 and 65 years old.

• having exposure at least once to an opioid (i.e. codeine, morphine, Fentanyl) in the past

Exclusion Criteria:

• using any psychoactive drug or medication at any time during the study, or 24 hours before the test session

• having a past or current diagnosis of drug abuse or dependence (except for nicotine), based on the SCID-IV interview (Structured Clinical Interview for DSM-IV)

• being maintained on methadone or buprenorphine, or taking opioid antagonist such as naltrexone

• having taken any opioid in the last 14 days

• having medical conditions, including Axis I psychiatric conditions under DSM-IV (examined with the MINI International Neuropsychiatric Interview-MINI), history of cardiac disease, arrhythmias, head trauma, and seizures

• having a history of hypersensitivity to any opioid or cannabinoid

• being pregnant or breastfeeding

• not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. spermicide, diaphragm)

• arriving to the study site visibly intoxicated as determined by a clinical evaluation for signs and symptoms of intoxication and as verified by a drug screen for cocaine, cannabis, opiates, benzodiazepines, barbiturates, phencyclidine and amphetamines

• being actively treated and currently involved in an addiction treatment program

• being an anesthesiologist or a pharmacist