Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Marijuana Dependence |
Drug: Marijuana |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Prevention |
| Official Title: | Comparison Between Marijuana Smoked in Cigarette Paper (Joints) Versus Cigar Paper (Blunts) |
| Estimated Enrollment: | 36 |
| Study Start Date: | December 2004 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Margaret Haney, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00374127 History of Changes |
| Other Study ID Numbers: | 4683 |
| Study First Received: | September 7, 2006 |
| Last Updated: | July 26, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York State Psychiatric Institute:
|
Marijuana Comparison between joints and blunts Pharmacokinetic effects |
Additional relevant MeSH terms:
|
Marijuana Abuse Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013