Laboratory Smoking of Marijuana "Blunts"

September 30, 2019 updated by: Battelle Memorial Institute
This is a double-blind within-subjects clinical laboratory study comparing the product appeal and abuse liability-related subjective effects of different flavored cigar wrappers for marijuana blunts.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

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
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Battelle Memorial 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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Currently living in Baltimore City or Baltimore County, MD;
  • Able to read, understand, and sign informed consent;
  • 18-55 years old;
  • Currently smokes marijuana blunts;
  • Designation of Medically Healthy for Research by the Study Physician; and
  • Willing to abstain from illicit drug use other than marijuana for the duration of the study.

Exclusion Criteria:

  • BAC > 0.020% as measured by alcohol breathalyzer;
  • Meets DSM-5 criteria for severe current or lifetime Cannabis Use Disorder;
  • Meets DSM-5 criteria for any current Axis I disorder, other than current mild or moderate Cannabis Use Disorder;
  • Self-reported current desire to stop marijuana use;
  • Self-reported current asthma, chronic obstructive pulmonary disease, hypertension, cardiovascular disease or any other medical illness that precludes participation;
  • Has difficulties with blood draws or poor venous access;
  • History of blood donation in the past 30 days or receiving blood products within the past 2 months prior to any experimental visit;
  • Among females, current pregnancy or lactation or attempting to get pregnant, or at risk of becoming pregnant;
  • Acute illness which will require participant to be rescheduled

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flavor 1
Grape flavored tobacco cigar wrapper
Drug: Marijuana
Marijuana smoked via blunts with different cigar wrappers
Experimental: Flavor 2
Chocolate flavored tobacco cigar wrapper
Drug: Marijuana
Marijuana smoked via blunts with different cigar wrappers
Experimental: Flavor 3
Tobacco flavored tobacco cigar wrapper
Drug: Marijuana
Marijuana smoked via blunts with different cigar wrappers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Puff topography
Time Frame: During marijuana blunt smoking
Total inhalation volume
During marijuana blunt smoking

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carbon monoxide
Time Frame: Immediately after marijuana blunt smoking
Exhaled breath carbon monoxide (ppm)
Immediately after marijuana blunt smoking
Subjective drug effects
Time Frame: Immediately after marijuana blunt smoking
Ratings of "good" and "high"
Immediately after marijuana blunt smoking
Measures of demand
Time Frame: Immediately after marijuana blunt smoking
Number of units an individual would purchase at varying price points
Immediately after marijuana blunt smoking

Collaborators and Investigators

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

Sponsor

Battelle Memorial Institute

Investigators

  • Principal Investigator: Wallace B Pickworth, PhD, Battelle Memorial Institute

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 (Actual)

April 10, 2019

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

May 23, 2018

First Submitted That Met QC Criteria

June 4, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

October 2, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMI-104112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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