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NCT03766971 Clinical Trial

Influence of Tobacco Use on Cannabis Use

Tobacco Use Clinical Trial

Official title:
Influence of Tobacco Use on Cannabis Use

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT03766971
Other study ID # 7707
Secondary ID
Status Suspended
Phase Phase 2
First received
Last updated
Start date February 1, 2020
Est. completion date November 30, 2025

Study information
Verified date August 2023
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Suspended
Enrollment 160
Est. completion date November 30, 2025
Est. primary completion date November 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• 7 days of Tobacco Cessation
Participants will be randomly assigned to 7 days of tobacco cessation.
• 21 days of Tobacco Cessation
Participants will be randomly assigned to 21 days of tobacco cessation.
Drug:
• Cannabis
Participants will receive cannabis.

Locations
Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (2)
Lead Sponsor Collaborator
New York State Psychiatric Institute National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cannabis self-administration Number of cannabis cigarettes participant chooses to smoke. During 9-day inpatient phase
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