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MJCIG: A Laboratory Model of Increasing Delta-9-tetrahydrocannabinol (THC) Potency on Cigarette Smoking

Sponsor
Battelle Memorial Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02961309
Collaborator
(none)
9
Enrollment
1
Location
2
Arms
16.8
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the proposed research is to investigate how smoking increasing potency of THC (i.e., the psychoactive ingredient in marijuana) changes tobacco cigarette smoking behavior, urges, subjective effects, and abuse liability. This study will be a within-subjects, placebo-controlled study in our clinical laboratory of the effect of active vs. placebo marijuana on cigarette puff topography, exhaled carbon monoxide, urge, subjective effects, and abuse liability among 7 adults who smoke both marijuana and tobacco cigarettes.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The study requires a total of three visits to Battelle's laboratory: one screening visit and two experimental visits. The screening visit will determine eligibility into the study. If eligible, participants will smoke a tobacco cigarette through the Clinical Research Support System (CReSS) puff topography device. Enrolled participants will attend two separate 5-hour experimental visits. Participants will be randomly assigned the order of THC potency (active or placebo), with the assignment blocked by sex. When participants arrive at the laboratory for each visit, they will provide biologic samples to verify compliance with pre-study instructions and then will be taken to a specially ventilated smoking chamber. They will be connected to a continuously-monitoring heart rate and blood pressure machine so that their vital signs can be observed throughout the smoking session. A research assistant will give a marijuana cigarette to the participant. A research assistant will light the cigarette and then exit the room. Participants will follow tape-recorded instructions for smoking the marijuana cigarette through the CReSS device. Upon completion of smoking the marijuana cigarette, participants will complete the Tobacco Craving Questionnaire via paper and pencil and will then be allowed to smoke one of his own tobacco cigarettes through the CReSS puff topography device. Participants will be allowed to smoke as many tobacco cigarettes as they would like for the next 3 hours. Participants will then be given lunch and sent home via taxicab. All participants will receive both potencies (i.e., active and placebo) of marijuana. The active potency of marijuana will be 5.6% THC.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
A Laboratory Model of Increasing THC Potency on Cigarette Smoking
Actual Study Start Date :
May 7, 2018
Actual Primary Completion Date :
Apr 24, 2019
Actual Study Completion Date :
Sep 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active THC

5.6% THC via smoked marijuana cigarette

Drug: THC
1 High-Potency THC (Dosage = 10mg) cigarette (oral smoking) on one day and 1 Placebo on the other day.
Other Names:
  • marijuana

    		•
    Experimental: Placebo

    Placebo THC via smoked cigarette

    Drug: THC
    1 High-Potency THC (Dosage = 10mg) cigarette (oral smoking) on one day and 1 Placebo on the other day.
    Other Names:
  • marijuana

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Puff topography of tobacco cigarette smoked [30 minutes post-marijuana smoking]

      Mean total puff volume

    Secondary Outcome Measures

    1. Boost in exhaled breath carbon monoxide after smoking tobacco cigarette [30 minutes post-marijuana smoking]

      Pre- to post-tobacco cigarette smoking difference in exhaled breath carbon monoxide

    2. Self-reported urge to smoke tobacco cigarette [30 minutes post marijuana smoking]

      Pre- to post-tobacco cigarette smoking difference in scores on the Questionnaire of Smoking Urge

    3. Self-reported subjective effects related to tobacco cigarette smoking [30 minutes post marijuana smoking]

      Pre- to post-tobacco cigarette smoking difference in the Nicotine-Drug Effects Questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Current US resident;

    2. Age ≥ 18 years;

    3. Self-reported smoking of marijuana no more than three days per week within the past year;

    4. Self-report past-month smoking of marijuana;

    5. Self-report daily smoking of at least five cigarettes per day within the past year;

    6. Cotinine ≥ 100 ng/mL at the in-person screening visit; and

    7. Able to read, understand, and sign informed consent.

    Exclusion Criteria:

    1. Meets Diagnostic and Statistical Manual-5 (DSM-5) criteria for current (i.e., past year) or past (i.e., lifetime) cannabis use disorder;

    2. Meets DSM-5 criteria for any current Axis I disorder, other than tobacco use disorder;

    3. Self-reported current desire to stop marijuana or tobacco use, defined as 7 or greater on an 11-rung (scaled of 1-10) Contemplation Ladder for each;

    4. Self-reported asthma or chronic obstructive pulmonary disease; and

    5. Among females, current pregnancy or lactation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Battelle Memorial Institute Baltimore Maryland United States 21209

    Sponsors and Collaborators

    • Battelle Memorial Institute

    Investigators

    • Principal Investigator: Wallace Pickworth, PhD, Battelle

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Battelle Memorial Institute
    ClinicalTrials.gov Identifier:
    NCT02961309
    Other Study ID Numbers:
    • BMI-73659
    First Posted:
    Nov 10, 2016
    Last Update Posted:
    Oct 2, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Battelle Memorial Institute
    THC
    marijuana
    tobacco cigarette
    smoking

    Study Results

    No Results Posted as of Oct 2, 2019