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OpenTrials
Suspended

NCT Number: NCT03766971

Influence of Tobacco Use on Cannabis Use

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.

Why the study stopped: In response to quality assurance and compliance concerns, OHRP issued an FWA restriction on NYSPI research that included a pause of human research as of June 23, 2023.
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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York State Psychiatric Institute

New York, 10032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

7 days of Tobacco Cessation

Behavioral

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

Other names: Early onset

21 days of Tobacco Cessation

Behavioral

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

Other names: Late onset

Cannabis

Drug

Participants will receive cannabis.

Primary outcomes

  1. Cannabis self-administration

    Time frame: During 9-day inpatient phase

    Number of cannabis cigarettes participant chooses to smoke.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Dec 6, 2018
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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