Influence of Tobacco Use on Cannabis Use

Phase 2

Suspended

• Conditions: Tobacco Use; Cannabis Use
• Interventions: Behavioral: 7 days of Tobacco Cessation; Behavioral: 21 days of Tobacco Cessation; Drug: Cannabis

• Registration Number: NCT03766971
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Study Start: 2020-02-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2025-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late-onset Cigarette Smokers	7 days of Tobacco Cessation	Participants who began smoking cigarettes later in life (\>16 years old) will be randomized to 7 or 21 days of tobacco cessation.
Early-onset Cigarette Smokers	7 days of Tobacco Cessation	Participants who began smoking cigarettes earlier in life (\<16 years old) will be randomized to 7 or 21 days of tobacco cessation.
Early-onset Cigarette Smokers	21 days of Tobacco Cessation	Participants who began smoking cigarettes earlier in life (\<16 years old) will be randomized to 7 or 21 days of tobacco cessation.
Late-onset Cigarette Smokers	Cannabis	Participants who began smoking cigarettes later in life (\>16 years old) will be randomized to 7 or 21 days of tobacco cessation.
Late-onset Cigarette Smokers	21 days of Tobacco Cessation	Participants who began smoking cigarettes later in life (\>16 years old) will be randomized to 7 or 21 days of tobacco cessation.
Early-onset Cigarette Smokers	Cannabis	Participants who began smoking cigarettes earlier in life (\<16 years old) will be randomized to 7 or 21 days of tobacco cessation.

Primary Outcome Measures

Name	Time	Method
Cannabis self-administration	During 9-day inpatient phase	Number of cannabis cigarettes participant chooses to smoke.

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States