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| Sponsors and Collaborators: |
New York State Psychiatric Institute Research Foundation for Mental Hygiene National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00743145 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Efficacy Study |
| Official Title: | Effects of Low-Dose Naltrexone in Combination With a Range of Smoked Marijuana |
| Estimated Enrollment: | 48 |
| Study Start Date: | May 2008 |
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:
Exclusion Criteria:
Contacts and Locations| Contact: Margaret Haney, Ph.D | 212-543-5175 |
| United States, New York | |
| New York State Psychiatric Institute | Recruiting |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Margaret Haney, Ph.D. | New York State Psychiatric Institute |
More Information
| Study ID Numbers: | 5693 |
| Study First Received: | August 26, 2008 |
| Last Updated: | August 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00743145 |
| Health Authority: | United States: Institutional Review Board |
|
naltrexone smoked marijuana marijuana use |
|
Smoking Mental Disorders Naltrexone Substance-Related Disorders |
Disorders of Environmental Origin Marijuana Smoking Marijuana Abuse |
|
Habits Sensory System Agents Therapeutic Uses Physiological Effects of Drugs |
Narcotic Antagonists Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |
