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临床试验/NCT00374127
NCT00374127已完成2 期

Comparison Between Marijuana Smoked in Cigarette Paper (Joints) Versus Cigar Paper (Blunts)

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2004年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
35
试验地点
1
主要终点
Plasma THC

研究概览

简要总结

The purpose of this study is to investigate whether or not marijuana blunts will produce comparable plasma THC levels as marijuana joints and if blunts will produce larger cardiovascular and subjective effects.

详细描述

There has been a rapid increase in marijuana use during the 1990s, with the most recent generation often smoking marijuana in the form of 'blunts' as opposed to more traditional routes such as in pipes or in cigarette paper. A blunt is made by removing the tobacco from a cigar and replacing it with marijuana (Golub and Johnson, 1999). The cigar wrapper contains tobacco and nicotine, which may interact with the cardiovascular and subjective effects of the marijuana to produce a different set of effects and risks than cigarette paper. Anecdotally, marijuana smokers report that blunts are more potent than joints, yet there have been no controlled studies addressing whether blunts enhance the subjective-effects and health-related consequences of marijuana use. We are proposing to do a within-subject, placebo-controlled study directly comparing the cardiovascular, subjective and pharmacokinetic effects of marijuana smoked in blunts compared to identical quantities of marijuana smoked in cigarette paper. Research volunteers will be current blunt smokers. Each will participate in six, 4-hour outpatient sessions. After baseline data have been collected (heart rate, blood pressure, mood scales, exhaled carbon monoxide, plasma THC and nicotine levels), participants will take 3 puffs, 5 seconds in duration, from a NIDA marijuana cigarette containing 0.0, 1.8 and 3.6% THC or from a blunt containing an equivalent quantity and strength of marijuana. Participants will be blind to the type of marijuana cigarette smoked. We will measure plasma THC and nicotine, subjective mood ratings, and heart rate and blood pressure repeatedly over the course of 180 minutes following smoking. This study is the first controlled investigation of the consequences of this new method of marijuana smoking; the data obtained may be useful in guiding future development of marijuana pharmacotherapy.

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)

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Current blunt marijuana use (minimum of twice/week) drug screen
  • 21-45 years of age
  • Practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD)

排除标准

  • Current, repeated illicit drug use(excluding marijuana)
  • Heavy cigarette use (> 10 cigarettes/day)
  • Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension)
  • Laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP > 140/90; hematocrit < 34 for women, < 36 for men)
  • Significant adverse reaction to marijuana
  • Current parole or probation
  • Pregnancy or current lactation
  • History of significant violent behavior
  • Major current Axis I psychopathology(e.g., mood disorder with functional impairment or suicide risk, anxiety disorder, schizophrenia)
  • History of heart disease
  • Current use of any over-the-counter or prescription

研究组 & 干预措施

marijuana blunt

Experimental

marijuana blunt (0%, 1.8%, or 3.6% THC)

干预措施: Marijuana blunt (Drug)

marijuana cigarette

Experimental

marijuana cigarette (0%, 1.8%, or 3.6% THC)

干预措施: marijuana cigarette (Drug)

结局指标

主要结局

Plasma THC

时间窗: 180 minutes

Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts.

次要结局

  • Subjective Effects on VAS(180 minutes)
  • Heart Rate(180 minutes)
  • Carbon Monoxide(180 minutes)
  • Subjective Effects on MRF(180 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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