Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper

NCT ID: NCT00374127

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2008-08-31

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.

Conditions

Marijuana Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

marijuana blunt

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

Group Type: EXPERIMENTAL

Marijuana blunt

Intervention Type: DRUG

Blunts were fabricated by cutting the bottom third off a Dutch Master® cigar, removing all of the cigar tobacco, and replacing it with all of the marijuana contained in a NIDA marijuana cigarette (ca. 800 mg).

marijuana cigarette

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

Group Type: EXPERIMENTAL

marijuana cigarette

Intervention Type: DRUG

Marijuana cigarettes were provided by the National Institute on Drug Abuse.

Interventions

Marijuana blunt

Blunts were fabricated by cutting the bottom third off a Dutch Master® cigar, removing all of the cigar tobacco, and replacing it with all of the marijuana contained in a NIDA marijuana cigarette (ca. 800 mg).

Intervention Type: DRUG

marijuana cigarette

Marijuana cigarettes were provided by the National Institute on Drug Abuse.

Intervention Type: DRUG

Other Intervention Names

Blunt; Joint

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Haney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

4683

Identifier Type: -

Identifier Source: org_study_id