Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Subjective Marijuana Effects
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind, placebo-controlled
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current marijuana use
- •Able to perform study procedures
- •Women practicing an effective form of birth control
排除标准
- •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
研究组 & 干预措施
Placebo naltrexone + Inactive marijuana
Placebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
干预措施: Inactive Marijuana (0% THC) (Drug)
Placebo naltrexone + Inactive marijuana
Placebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
干预措施: Placebo naltrexone (Drug)
Placebo naltrexone + Active marijuana (5.5% THC)
Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
干预措施: Active Marijuana (5.5% THC) (Drug)
Placebo naltrexone + Active marijuana (5.5% THC)
Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
干预措施: Placebo naltrexone (Drug)
Placebo naltrexone + Active marijuana (6.2% THC)
Placebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
干预措施: Active Marijuana (6.2% THC) (Drug)
Placebo naltrexone + Active marijuana (6.2% THC)
Placebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
干预措施: Placebo naltrexone (Drug)
Naltrexone + Active marijuana (5.5% THC)
Naltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
干预措施: Active Marijuana (5.5% THC) (Drug)
Naltrexone + Active marijuana (5.5% THC)
Naltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
干预措施: Naltrexone (Drug)
Naltrexone + Active marijuana (6.2% THC)
Naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
干预措施: Active Marijuana (6.2% THC) (Drug)
Naltrexone + Active marijuana (6.2% THC)
Naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
干预措施: Naltrexone (Drug)
Naltrexone + Inactive marijuana
Naltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
干预措施: Inactive Marijuana (0% THC) (Drug)
Naltrexone + Inactive marijuana
Naltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
干预措施: Naltrexone (Drug)
结局指标
主要结局
Subjective Marijuana Effects
时间窗: 180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks.
Subjective ratings of marijuana's quality and effect ('Strength', 'Good Effect', 'High', 'Stimulation') and craving ('Want Marijuana') as a function of active puffs and naltrexone, using a visual analogue scale with a series of 100 mm long lines labeled 'not at all' at one end (0 mm) and 'extremely' at the other end (100 mm). Participants were instructed to indicate how they felt at that particular moment. Higher ratings indicate more agreement with the statement.
次要结局
未报告次要终点
研究者
Margaret Haney
Clinical Psychaitrist
New York State Psychiatric Institute