Influence of Tobacco Use on Cannabis Use

NCT ID: NCT03766971

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cannabis Use Tobacco Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Research staff will be blind to the age of tobacco onset condition.

Study Groups

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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.

Group Type EXPERIMENTAL

7 days of Tobacco Cessation

Intervention Type BEHAVIORAL

Participants will be randomly assigned to 7 days of tobacco cessation.

21 days of Tobacco Cessation

Intervention Type BEHAVIORAL

Participants will be randomly assigned to 21 days of tobacco cessation.

Cannabis

Intervention Type DRUG

Participants will receive cannabis.

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.

Group Type EXPERIMENTAL

7 days of Tobacco Cessation

Intervention Type BEHAVIORAL

Participants will be randomly assigned to 7 days of tobacco cessation.

21 days of Tobacco Cessation

Intervention Type BEHAVIORAL

Participants will be randomly assigned to 21 days of tobacco cessation.

Cannabis

Intervention Type DRUG

Participants will receive cannabis.

Interventions

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7 days of Tobacco Cessation

Participants will be randomly assigned to 7 days of tobacco cessation.

Intervention Type BEHAVIORAL

21 days of Tobacco Cessation

Participants will be randomly assigned to 21 days of tobacco cessation.

Intervention Type BEHAVIORAL

Cannabis

Participants will receive cannabis.

Intervention Type DRUG

Other Intervention Names

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Early onset Late onset

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Margaret Haney

Professor of Psychiatry, Columbia University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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7707

Identifier Type: -

Identifier Source: org_study_id

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