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Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00374127
First Posted: September 8, 2006
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
September 7, 2006
September 8, 2006
August 3, 2017
September 1, 2017
September 1, 2017
December 2004
August 2008   (Final data collection date for primary outcome measure)
Plasma THC [ Time Frame: 180 minutes ]
Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts.
Not Provided
Complete list of historical versions of study NCT00374127 on ClinicalTrials.gov Archive Site
  • Subjective Effects on MRF [ Time Frame: 180 minutes ]
    Using the Marijuana Rating Form (MRF), subjective effects of "Take Again", "Liking", and "Strong" were assessed. The MRF is a visual analog scale allowing patients to indicate how they feel on a 100-mm line anchored with 'not at all' at the left end and 'extremely' at the right end, when prompted by a statement.
  • Subjective Effects on VAS [ Time Frame: 180 minutes ]
    Subjective VAS ratings of 'Good Drug Effect' and 'High' averaged across all post-smoking time points when marijuana was smoked as joints and blunts analyzed for all participants. Here, participants indicated how they were feeling on a 100-mm line anchored with 'not at all' at the left end and 'extremely' at the right end, when prompted by a statement
  • Carbon Monoxide [ Time Frame: 180 minutes ]
    Expired carbon monoxide averaged across all post-smoking time points when marijuana was smoked as joints and blunts for all participants.
  • Heart Rate [ Time Frame: 180 minutes ]
    Heart rate averaged across all post-smoking time points when marijuana was smoked as joints and blunts.
Not Provided
Not Provided
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Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper
Comparison Between Marijuana Smoked in Cigarette Paper (Joints) Versus Cigar Paper (Blunts)
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Marijuana Dependence
  • Drug: 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).
    Other Name: Blunt
  • Drug: marijuana cigarette
    Marijuana cigarettes were provided by the National Institute on Drug Abuse.
    Other Name: Joint
  • Experimental: marijuana blunt
    marijuana blunt (0%, 1.8%, or 3.6% THC)
    Intervention: Drug: Marijuana blunt
  • Experimental: marijuana cigarette
    marijuana cigarette (0%, 1.8%, or 3.6% THC)
    Intervention: Drug: marijuana cigarette
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00374127
4683
Not Provided
Not Provided
Not Provided
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Margaret Haney, Ph.D. New York State Psychiatric Institute
New York State Psychiatric Institute
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP