Influence of Tobacco Use on Cannabis Use

August 13, 2025 updated by: Margaret Haney, New York State Psychiatric Institute
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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

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
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric 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 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannabis self-administration
Time Frame: During 9-day inpatient phase
Number of cannabis cigarettes participant chooses to smoke.
During 9-day inpatient phase

Collaborators and Investigators

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

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

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)

February 1, 2020

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7707 (Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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