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
• Status: Suspended
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana Abuse
• Tobacco Use

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