Phase 2
N=23
Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
Marijuana Smoking
Bottom Line
View on ClinicalTrials.gov: NCT00743145 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Subjective Marijuana Effects — 13; 15; 16; 16 units on a scale (0-100mm)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Inactive Marijuana (0% THC) (Drug); Active Marijuana (5.5% THC) (Drug); Active Marijuana (6.2% THC) (Drug); Naltrexone (Drug); Placebo naltrexone (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Marijuana Effects |
13; 15; 16; 16; 20; 16 | — |
Summary
In heavy marijuana smokers, opioid receptor blockade increases the subjective and cardiovascular effects of marijuana. The current study was designed to clarify opioid-cannabinoid interactions by assessing how naltrexone shifts the dose-response function for marijuana-elicited effects in heavy marijuana smokers. For this within-subject, double-blind study, a marijuana smoking procedure was designed to characterize a dose-response relationship for marijuana's subjective and cardiovascular effects under blinded conditions.
Eligibility Criteria
Inclusion Criteria
- Current marijuana use
- Able to perform study procedures
- Women practicing an effective form of birth control
Exclusion Criteria
- Current repeated illicit drug use (other than marijuana)
- Presence of significant medical illness (e.g., diabetes, cardiovascular disease,hypertension, hepatitis, clinically significant laboratory abnormalities, LFTs > 3x upper limit of normal, blood pressure > 140/90
Data sourced from ClinicalTrials.gov (NCT00743145). 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.