Overview

Acute and Short-term Effects of Cannabidiol Admin on Cue-induced Craving in Drug-abstinent Heroin Dependent Humans

Status:
Completed
Trial end date:
2013-10-01
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hurd,Yasmin, Ph.D.
Treatments:
Cannabidiol
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 DSM-IV(SCID-IV) 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-IV 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-IV
(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)