Acute and Short-term Effects of CBD on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans

• Status: Completed
• Trial end date: 2017-05-24
• 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hurd,Yasmin, Ph.D.
• Collaborator: GW Research Ltd
• Treatments: Heroin

Criteria

Inclusion Criteria:

• Must be between 21 and 65 years old

• Must have an opiate dependence that meets criteria set in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Structured Clinical Interview for DSM (SCID-V) over the last three months

• No opioid use in the past 7 days (will be verified via urine drug screen and opiate metabolite test)

Exclusion Criteria:

• Using any psychoactive drug (other than nicotine) any time up to test session 3

• Having a diagnosis of drug dependence (except for heroin or nicotine) in the past 3 months, based on the SCID-V interview criteria

• Being maintained on methadone or buprenorphine, or taking opioid antagonists such as naltrexone

• Having a positive a drug screen

• Showing signs of acute heroin withdrawal symptoms

• Having medical conditions, including Axis I psychiatric conditions under DSM-V (examined using the Mini International Neuropsychiatric Interview [MINI])

• Having a a history of cardiac disease, arrhythmias, head trauma, and seizures

• Having a history of hypersensitivity to cannabinoids

• 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

• Participating in a another pharmacotherapeutic trial in the past 3 months

• Being pregnant of breastfeeding

• Not using or irregularly using appropriate methods of contraception such as hormonal contraceptives (e.g., Depo-Provera, Nuva-Ring), an intrauterine device (IUD), or double barrier method (combination of any two barrier methods used simultaneously, e.g., condoms, spermicide, diaphragms)