Phase 2
N=42
Acute and Short-term Effects of CBD on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans
Opiate Addiction
Bottom Line
View on ClinicalTrials.gov: NCT02539823 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: 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) — 1.40; 1.64; 2.31; 1.33 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CBD 400 mg (Drug); CBD 800 mg (Drug); Control (placebo) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Hurd,Yasmin, Ph.D.
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
1.40; 1.64; 2.31; 1.33; 1.07; 1.46 | — |
| PRIMARY 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) |
60.13; 59.33; 59.75; 53.20; 50.00; 53.42 | — |
| SECONDARY Vital Signs |
76.75; 76.30; 78.00; 76.25; 75.80; 77.57 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT02539823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.