Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
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Purpose
The purpose of this study is to determine how naltrexone shifts the marijuana-response curve, a single, low-dose of naltrexone (12 mg/70 kg) or placebo will be administered 45 minutes before smoking marijuana (0,2,4,6,puffs of 6.2% THC). Naltrexone (12 mg/70 kg) or placebo will be administered 45 minutes before smoking to assess how opioid receptor blockade affects marijuana's subjective and physiologic effects. It is predicted that increasing the number of puffs of active marijuana will increase positive subjective ratings of marijuana and naltrexone and further increase these ratings.
| Condition | Intervention | Phase |
|---|---|---|
|
Marijuana Smoking |
Drug: Naltrexone Drug: Smoked marijuana |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana |
| Estimated Enrollment: | 48 |
| Study Start Date: | May 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
-
Drug: Naltrexone
Laboratory animal studies have convincingly demonstrated that opioid antagonists decrease the behavioral effects of cannabinoids. By contrast, in humans, the opioid antagonist naltrexone (12, 25, 50 and 100 mg) increases the subjective effects of a single strength of smoked marijuana (3.27% THC). A logical follow up to this finding is to determine how naltrexone shifts the marijuana-response curve. In the present study a single low dose of naltrexone (12 mg/70 kg, po) will be administered prior to a range of puffs of a marijuana cigarette (0, 2, 4, 6, puffs of 6.2% THC.) Non-treatment-seeking marijuana smokers will be recruited for an eight-session study during which the subjective, cognitive, and physiologic effects of smoked marijuana will be evaluated. Naltrexone (12 mg/70 kg, po) or placebo will be administered 45 minutes before smoking to assess how opioid receptor blockade effects marijuana's subjective and physiologic effects.
Eligibility| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, New York | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Margaret Haney, Ph.D. | New York State Psychiatric Institute |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00743145 History of Changes |
| Other Study ID Numbers: | 5693 |
| Study First Received: | August 26, 2008 |
| Last Updated: | September 22, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York State Psychiatric Institute:
|
naltrexone smoked marijuana marijuana use |
Additional relevant MeSH terms:
|
Marijuana Abuse Marijuana Smoking Smoking Substance-Related Disorders Mental Disorders Habits Naltrexone |
Narcotic Antagonists Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013