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Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00374127
First received: September 7, 2006
Last updated: October 25, 2016
Last verified: October 2016

September 7, 2006
October 25, 2016
December 2004
August 2008   (final data collection date for primary outcome measure)
plasma THC [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00374127 on ClinicalTrials.gov Archive Site
subjective effects [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]
Not Provided
cardiovascular effects and carbon monoxide levels [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]
Not Provided
 
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Marijuana Dependence
  • Drug: Marijuana
  • Drug: Naltrexone
  • Experimental: naltrexone, marijuana
    naltrexone (12, 25, 50, and 100 mg ReVia; Dupont Pharma) marijuana cigarette (0 or 3.27% THC; ca. 800 mg)
    Interventions:
    • Drug: Marijuana
    • Drug: Naltrexone
  • Placebo Comparator: placebo, marijuana
    marijuana cigarette (0 or 3.27% THC; ca. 800 mg)
    Intervention: Drug: Marijuana
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
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
Both
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
October 2016

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