Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper
Primary Purpose
Marijuana Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Marijuana blunt
marijuana cigarette
Sponsored by
About this trial
This is an interventional basic science trial for Marijuana Dependence focused on measuring Marijuana, Comparison between joints and blunts, Pharmacokinetic effects
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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
marijuana blunt
marijuana cigarette
Arm Description
marijuana blunt (0%, 1.8%, or 3.6% THC)
marijuana cigarette (0%, 1.8%, or 3.6% THC)
Outcomes
Primary Outcome Measures
Plasma THC
Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts.
Secondary Outcome Measures
Subjective Effects on MRF
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
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
Expired carbon monoxide averaged across all post-smoking time points when marijuana was smoked as joints and blunts for all participants.
Heart Rate
Heart rate averaged across all post-smoking time points when marijuana was smoked as joints and blunts.
Full Information
NCT ID
NCT00374127
First Posted
September 7, 2006
Last Updated
August 3, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00374127
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Dependence
Keywords
Marijuana, Comparison between joints and blunts, Pharmacokinetic effects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
marijuana blunt
Arm Type
Experimental
Arm Description
marijuana blunt (0%, 1.8%, or 3.6% THC)
Arm Title
marijuana cigarette
Arm Type
Experimental
Arm Description
marijuana cigarette (0%, 1.8%, or 3.6% THC)
Intervention Type
Drug
Intervention Name(s)
Marijuana blunt
Other Intervention Name(s)
Blunt
Intervention Description
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
Intervention Name(s)
marijuana cigarette
Other Intervention Name(s)
Joint
Intervention Description
Marijuana cigarettes were provided by the National Institute on Drug Abuse.
Primary Outcome Measure Information:
Title
Plasma THC
Description
Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts.
Time Frame
180 minutes
Secondary Outcome Measure Information:
Title
Subjective Effects on MRF
Description
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.
Time Frame
180 minutes
Title
Subjective Effects on VAS
Description
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
Time Frame
180 minutes
Title
Carbon Monoxide
Description
Expired carbon monoxide averaged across all post-smoking time points when marijuana was smoked as joints and blunts for all participants.
Time Frame
180 minutes
Title
Heart Rate
Description
Heart rate averaged across all post-smoking time points when marijuana was smoked as joints and blunts.
Time Frame
180 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Haney, Ph.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
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Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper
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