Clinical trial NCT00374127: Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper
Official title: Comparison Between Marijuana Smoked in Cigarette Paper (Joints) Versus Cigar Paper (Blunts)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Marijuana Dependence
Keywords: Marijuana
Comparison between joints and blunts
Pharmacokinetic effects
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-09-08
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Plasma THC
timeFrame: 180 minutes
Secondary outcomes:
measure: Subjective Effects on MRF
timeFrame: 180 minutes
measure: Subjective Effects on VAS
timeFrame: 180 minutes
measure: Carbon Monoxide
timeFrame: 180 minutes
measure: Heart Rate
timeFrame: 180 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Margaret Haney, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: