Influence of Tobacco Use on Cannabis Use

NCT03766971 | Suspended Phase 2 DMC FDA Drug

• 1 other identifier: 7707
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Cannabis self-administration

  Number of cannabis cigarettes participant chooses to smoke.

  During 9-day inpatient phase

Study Arms (2)

Early-onset Cigarette Smokers

EXPERIMENTAL

Participants who began smoking cigarettes earlier in life (\<16 years old) will be randomized to 7 or 21 days of tobacco cessation.

Behavioral: 7 days of Tobacco Cessation; Behavioral: 21 days of Tobacco Cessation; Drug: Cannabis

Late-onset Cigarette Smokers

EXPERIMENTAL

Participants who began smoking cigarettes later in life (\>16 years old) will be randomized to 7 or 21 days of tobacco cessation.

Behavioral: 7 days of Tobacco Cessation; Behavioral: 21 days of Tobacco Cessation; Drug: Cannabis

Interventions

7 days of Tobacco Cessation BEHAVIORAL

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

Also known as: Early onset

Early-onset Cigarette Smokers; Late-onset Cigarette Smokers

21 days of Tobacco Cessation BEHAVIORAL

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

Also known as: Late onset

Early-onset Cigarette Smokers; Late-onset Cigarette Smokers

Cannabis DRUG

Participants will receive cannabis.

Early-onset Cigarette Smokers; Late-onset Cigarette Smokers

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and non-pregnant females aged 18-60 years old
• Use cannabis
• Smoke tobacco cigarettes
• Medically and psychologically healthy

You may not qualify if:

• Regular drug use other than cannabis
• Current pregnancy/lactation

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Tobacco Use

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research staff will be blind to the age of tobacco onset condition.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry, Columbia University

Model Details: 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).

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 6, 2018
• Study Start: February 1, 2020
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (1)