Phase 2
N=10
Acute and Short-term Effects of Cannabidiol Admin on Cue-induced Craving in Drug-abstinent Heroin Dependent Humans
Opiate Addiction
Bottom Line
View on ClinicalTrials.gov: NCT01605539 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC) — 2.67; 0.83; -0.33; -0.17 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cannabidiol 400 (Drug); Cannabidiol 800 (Drug); Control (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Hurd,Yasmin, Ph.D.
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC) |
2.67; 0.83; -0.33; -0.17; 0.670; 0.67 | — |
| PRIMARY Changes in Out-of-Clinic Craving (From Pre-Dose to Approximately 6 Hours Post-Dose for Test Visits I and II; and From Pre-Dose Test Visit I to Pre-Cue Test Visit IV) - Via the Heroin Craving Questionnaire (HCQ) |
-3.67; -0.33; -5.33; -6.17; -4.33; -16.33 | — |
| SECONDARY Vital Signs - Blood Pressure |
8.33; 4.5; -0.33; 0.17; -8.67; 8.5 | — |
| SECONDARY Visual Analog Scale for Anxiety (VASA) |
2.00; 0.00; 0.33; -0.33; 1.33; -0.50 | — |
| SECONDARY The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data |
1.33; -0.50; 1.33; -1.83; -4.00; -1.00 | — |
| SECONDARY The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data |
4.00; 0.50; 1.33; -1.50; 4.00; 0.00 | — |
| SECONDARY Vital Signs - Heart Rate |
-2.33; 4.00; -6; 2.5; -8; -6.5 | — |
| SECONDARY Vital Signs - Respiratory Rate |
0; 0; 0; 0; -0.67; 0 | — |
| SECONDARY Vital Signs - Temperature |
0.03; -3.35; 0.43; 0.03; 0.0; 0.05 | — |
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 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)
Data sourced from ClinicalTrials.gov (NCT01605539). 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.