CompletedPhase 2

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

United States45 participantsStarted 2015-09

Plain-language 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.

Who can participate

Age range21 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)

Timeframe: VASC: test day I, II and IV - at arrival, baseline for cue 1 and 2, post-cue 1 and 2, before discharge (approximately 2.5 hours from session start on average); test day III: at arrival and discharge (approx. 2.5 hours from session start on average)

Changes in Out-of-Clinic Craving (From Pre-dose to Approximately 4-6 Hours Post-dose; and From Test Day 1 to Test Day 4 or 1 Week) - Via the Heroin Craving Questionnaire (HCQ)

Timeframe: HCQ: once in clinic pre-dose at each test day, and once at home after each test day.

Trial details

NCT IDNCT02539823

SponsorHurd,Yasmin, Ph.D.

Sponsor typeINDIV

Study typeINTERVENTIONAL

Primary completion2017-05-24

Results submitted2020-08-04

View on ClinicalTrials.gov More Opiate Addiction trials