- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03766971
Influence of Tobacco Use on Cannabis Use
August 30, 2026 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
-
-
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.
|
Participants will be randomly assigned to 7 days of tobacco cessation.
Other Names:
Participants will be randomly assigned to 21 days of tobacco cessation.
Other Names:
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.
|
Participants will be randomly assigned to 7 days of tobacco cessation.
Other Names:
Participants will be randomly assigned to 21 days of tobacco cessation.
Other Names:
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.
Collaborators
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, 2027
Study Completion (Estimated)
November 30, 2028
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)
September 1, 2026
Last Update Submitted That Met QC Criteria
August 30, 2026
Last Verified
August 1, 2026
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.