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Laboratory Smoking of Marijuana "Blunts"

Primary Purpose

Cannabis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Marijuana
Sponsored by
Battelle Memorial Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cannabis focused on measuring Cannabis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Battelle Memorial Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Flavor 1

Flavor 2

Flavor 3

Arm Description

Grape flavored tobacco cigar wrapper

Chocolate flavored tobacco cigar wrapper

Tobacco flavored tobacco cigar wrapper

Outcomes

Primary Outcome Measures

Puff topography
Total inhalation volume

Secondary Outcome Measures

Carbon monoxide
Exhaled breath carbon monoxide (ppm)
Subjective drug effects
Ratings of "good" and "high"
Measures of demand
Number of units an individual would purchase at varying price points

Full Information

First Posted
May 23, 2018
Last Updated
September 30, 2019
Sponsor
Battelle Memorial Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03546790
Brief Title
Laboratory Smoking of Marijuana "Blunts"
Official Title
Laboratory Smoking of Marijuana "Blunts"
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Battelle Memorial Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis
Keywords
Cannabis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flavor 1
Arm Type
Experimental
Arm Description
Grape flavored tobacco cigar wrapper
Arm Title
Flavor 2
Arm Type
Experimental
Arm Description
Chocolate flavored tobacco cigar wrapper
Arm Title
Flavor 3
Arm Type
Experimental
Arm Description
Tobacco flavored tobacco cigar wrapper
Intervention Type
Drug
Intervention Name(s)
Marijuana
Intervention Description
Marijuana smoked via blunts with different cigar wrappers
Primary Outcome Measure Information:
Title
Puff topography
Description
Total inhalation volume
Time Frame
During marijuana blunt smoking
Secondary Outcome Measure Information:
Title
Carbon monoxide
Description
Exhaled breath carbon monoxide (ppm)
Time Frame
Immediately after marijuana blunt smoking
Title
Subjective drug effects
Description
Ratings of "good" and "high"
Time Frame
Immediately after marijuana blunt smoking
Title
Measures of demand
Description
Number of units an individual would purchase at varying price points
Time Frame
Immediately after marijuana blunt smoking

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wallace B Pickworth, PhD
Organizational Affiliation
Battelle Memorial Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Battelle Memorial Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Laboratory Smoking of Marijuana "Blunts"

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