Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana
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Purpose
The purpose of this study is to determine if the subjective effects of marijuana will be decreased by low-doses (< 25 mg) of naltrexone and increased by high-doses (> 50 mg) of naltrexone.
| Condition | Intervention | Phase |
|---|---|---|
|
Marijuana Smoking |
Drug: Naltrexone Drug: 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2006 |
Laboratory animal studies demonstrate that endogenous cannabinoids and opioids are closely inter-related. We have completed a series of studies in marijuana smokers showing that a clinically-utilized dose of naltrexone (50 mg) enhanced the reinforcing and subjective effects of orally-administered tetrahydrocannabinol (THC), while a low naltrexone dose (12 mg) blunted the effects of THC. A better understanding of the effects of a range of naltrexone doses in combination with smoked marijuana has important implications for the following reasons: (1) Alcohol- and opioid-dependent patients receive high doses of naltrexone (50-150 mg), which may increase the abuse liability of marijuana, (2) Low-dose naltrexone blunts THC's intoxicating effects, suggesting potential utility as a treatment medication for marijuana dependence. This study will determine if naltrexone (0, 12, 25, 50, 100 mg) administration 45 min prior to marijuana administration (0, 3.9% THC) alters marijuana's subjective, cognitive or physiological effects. Marijuana smokers will spend approximately 5h/day for a total of 10 days in the outpatient laboratory. Participants will visit the outpatient laboratory 2-3 times per week, with a minimum 48-hr interval between sessions to allow for naltrexone clearance. These data will provide important information regarding the clinical use of naltrexone.
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
- 21-45 years of age
- 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, examination, laboratory hepatitis, clinically significant laboratory abnormalities, tests, 12-lead ECG, Mantoux test LFTs > 3x upper limit of normal)
- History of heart disease
- Request for drug treatment
- Current parole or probation
- Pregnancy or current lactation
- Recent history of significant violent behavior
- Previous adverse reaction to naltrexone
- Major current Axis I psychopathology Psychiatric interview (e.g., major depressive disorder, bipolar disorder, suicide risk, schizophrenia)
- Current use of any prescription or over-the-counter medication
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00403117 History of Changes |
| Other Study ID Numbers: | 5360 |
| Study First Received: | November 21, 2006 |
| Last Updated: | August 26, 2008 |
| 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 19, 2013