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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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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7 days of Tobacco Cessation | Behavioral | Participants will be randomly assigned to 7 days of tobacco cessation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cannabis self-administration | Number of cannabis cigarettes participant chooses to smoke. | During 9-day inpatient phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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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).
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Research staff will be blind to the age of tobacco onset condition.
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| 21 days of Tobacco Cessation | Behavioral | Participants will be randomly assigned to 21 days of tobacco cessation. |
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| Cannabis | Drug | Participants will receive cannabis. |
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