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Influence of Tobacco Use on Cannabis Use

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03766971
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
160
Enrollment
1
Location
2
Arms
58
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cannabis smokers who also smoke tobacco cigarettes have markedly higher rates of cannabis relapse relative to those who do not use tobacco. There is a clear need to develop and evaluate interventions for dual tobacco and cannabis users. The investigators of this study have previously shown that the co-use of tobacco cigarettes contributes to the maintenance of daily cannabis use, and that age of cigarette onset is a critical predictor of treatment outcome. Short-term tobacco cessation may suffice in altering cannabis relapse rates in later-onset cigarette smokers, while a longer period of tobacco cessation may be needed for earlier-onset smokers. In the current study, a human laboratory model will be utilized to determine whether cannabis relapse varies as a function of tobacco cessation duration and age of tobacco use onset.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: 7 days of Tobacco Cessation
  • Behavioral: 21 days of Tobacco Cessation
  • Drug: Cannabis
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The effects of 7- and 21-days of tobacco cessation on cannabis relapse in daily cigarette-smoking, cannabis smokers will be compared, with half the participants in each group initiating tobacco cigarette smoking early (<16 years) and the other half later (>=16 years).The effects of 7- and 21-days of tobacco cessation on cannabis relapse in daily cigarette-smoking, cannabis smokers will be compared, with half the participants in each group initiating tobacco cigarette smoking early (<16 years) and the other half later (>=16 years).
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Research staff will be blind to the age of tobacco onset condition.
Primary Purpose:
Other
Official Title:
Influence of Tobacco Use on Cannabis Use
Actual Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Nov 30, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Early-onset Cigarette Smokers

Participants who began smoking cigarettes earlier in life (<16 years old) will be randomized to 7 or 21 days of tobacco cessation.

Behavioral: 7 days of Tobacco Cessation
Participants will be randomly assigned to 7 days of tobacco cessation.
Other Names:
  • Early onset

    • Behavioral: 21 days of Tobacco Cessation
    Participants will be randomly assigned to 21 days of tobacco cessation.
    Other Names:
  • Late onset

    • Drug: Cannabis
    Participants will receive cannabis.
    Experimental: Late-onset Cigarette Smokers

    Participants who began smoking cigarettes later in life (>16 years old) will be randomized to 7 or 21 days of tobacco cessation.

    Behavioral: 7 days of Tobacco Cessation
    Participants will be randomly assigned to 7 days of tobacco cessation.
    Other Names:
  • Early onset

    • Behavioral: 21 days of Tobacco Cessation
    Participants will be randomly assigned to 21 days of tobacco cessation.
    Other Names:
  • Late onset

    • Drug: Cannabis
    Participants will receive cannabis.

    Outcome Measures

    Primary Outcome Measures

    1. Cannabis self-administration [During 9-day inpatient phase]

      Number of cannabis cigarettes participant chooses to smoke.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Males and non-pregnant females aged 18-60 years old

    • Use cannabis

    • Smoke tobacco cigarettes

    • Medically and psychologically healthy

    Exclusion Criteria:

    • Regular drug use other than cannabis

    • Current pregnancy/lactation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York State Psychiatric Institute New York New York United States 10032

    Sponsors and Collaborators

    • New York State Psychiatric Institute
    • National Institute on Drug Abuse (NIDA)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Margaret Haney, Professor of Psychiatry, Columbia University, New York State Psychiatric Institute
    ClinicalTrials.gov Identifier:
    NCT03766971
    Other Study ID Numbers:
    • 7707
    First Posted:
    Dec 6, 2018
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Marijuana Abuse

    Study Results

    No Results Posted as of Mar 31, 2022