Influence of Tobacco Use on Cannabis Use
Primary Purpose
Cannabis Use, Tobacco Use
Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
7 days of Tobacco Cessation
21 days of Tobacco Cessation
Cannabis
Sponsored by
About this trial
This is an interventional other trial for Cannabis Use
Eligibility Criteria
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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Early-onset Cigarette Smokers
Late-onset Cigarette Smokers
Arm Description
Participants who began smoking cigarettes earlier in life (<16 years old) will be randomized to 7 or 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.
Outcomes
Primary Outcome Measures
Cannabis self-administration
Number of cannabis cigarettes participant chooses to smoke.
Secondary Outcome Measures
Full Information
NCT ID
NCT03766971
First Posted
December 4, 2018
Last Updated
August 9, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03766971
Brief Title
Influence of Tobacco Use on Cannabis Use
Official Title
Influence of Tobacco Use on Cannabis Use
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why 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.
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use, Tobacco Use
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Research staff will be blind to the age of tobacco onset condition.
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early-onset Cigarette Smokers
Arm Type
Experimental
Arm Description
Participants who began smoking cigarettes earlier in life (<16 years old) will be randomized to 7 or 21 days of tobacco cessation.
Arm Title
Late-onset Cigarette Smokers
Arm Type
Experimental
Arm Description
Participants who began smoking cigarettes later in life (>16 years old) will be randomized to 7 or 21 days of tobacco cessation.
Intervention Type
Behavioral
Intervention Name(s)
7 days of Tobacco Cessation
Other Intervention Name(s)
Early onset
Intervention Description
Participants will be randomly assigned to 7 days of tobacco cessation.
Intervention Type
Behavioral
Intervention Name(s)
21 days of Tobacco Cessation
Other Intervention Name(s)
Late onset
Intervention Description
Participants will be randomly assigned to 21 days of tobacco cessation.
Intervention Type
Drug
Intervention Name(s)
Cannabis
Intervention Description
Participants will receive cannabis.
Primary Outcome Measure Information:
Title
Cannabis self-administration
Description
Number of cannabis cigarettes participant chooses to smoke.
Time Frame
During 9-day inpatient phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Influence of Tobacco Use on Cannabis Use
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