Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper

August 3, 2017 updated by: New York State Psychiatric Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: marijuana blunt
marijuana blunt (0%, 1.8%, or 3.6% THC)
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 Names:
  • Blunt
Experimental: marijuana cigarette
marijuana cigarette (0%, 1.8%, or 3.6% THC)
Drug: marijuana cigarette
Marijuana cigarettes were provided by the National Institute on Drug Abuse.
Other Names:
  • Joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma THC
Time Frame: 180 minutes
Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts.
180 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
180 minutes
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
180 minutes
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.
180 minutes
Heart Rate
Time Frame: 180 minutes
Heart rate averaged across all post-smoking time points when marijuana was smoked as joints and blunts.
180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

September 7, 2006

First Submitted That Met QC Criteria

September 7, 2006

First Posted (Estimate)

September 8, 2006

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4683

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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