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Influence of Tobacco Use on Cannabis Use

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ClinicalTrials.gov Identifier: NCT03766971
Recruitment Status : Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Margaret Haney, New York State Psychiatric Institute

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
Cannabis Use Tobacco Use Behavioral: 7 days of Tobacco Cessation Behavioral: 21 days of Tobacco Cessation Drug: Cannabis Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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).
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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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 Name: Early onset

Behavioral: 21 days of Tobacco Cessation
Participants will be randomly assigned to 21 days of tobacco cessation.
Other Name: 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 Name: Early onset

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

Drug: Cannabis
Participants will receive cannabis.




Primary Outcome Measures :
  1. Cannabis self-administration [ Time Frame: During 9-day inpatient phase ]
    Number of cannabis cigarettes participant chooses to smoke.



Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766971


Contacts
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Contact: Meg Haney, PhD 6467746129 meg.haney@nyspi.columbia.edu

Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)

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Responsible Party: Margaret Haney, Professor of Psychiatry, Columbia University, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03766971     History of Changes
Other Study ID Numbers: 7707
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders