Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
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.
|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|
|Study Start Date:||May 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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.
|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|