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

Completed · Phase 1 · Has a placebo group

Conditions studied: Opiate Addiction

In brief

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.

Key facts

Study ID

NCT01311778

Run by

Hurd,Yasmin, Ph.D.

People needed

18

Starts

2010-02-01

Expected to finish

2011-10-01

Last updated by the study team

2013-03-22

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• being aged between 21 and 65 years old.
• having exposure at least once to an opioid (i.e. codeine, morphine, Fentanyl) in the past

You may not qualify if…

• 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

Where it is running

• Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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