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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01DA036486-02S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study examines the potential effect of reducing nicotine content or menthol or both in men. It will also examine whether there are gender differences in manipulating tobacco flavors and nicotine concentrations in cigarettes on smoking behavior.
The FDA has the regulatory authority to reduce, but not eliminate, nicotine from cigarettes. The Tobacco Products Scientific Advisory Committee has noted, among other things, that removal of menthol cigarettes from the marketplace would benefit the public health. A parent study (NCT02048852) examines the potential impact of these two regulatory actions alone and in combination in female menthol smokers. This supplemental study will recruit an additional group of male menthol smokers, which will examine whether there are gender differences in manipulating flavors and nicotine concentrations in cigarettes on smoking behavior. The approach to add the opposite sex allows findings of sex/gender to be incorporated in the design and development of new technologies (i.e., modified cigarettes). Emerging research shows that women may be more responsive to the non-nicotine sensory aspects of smoking such as menthol flavor, whereas men may smoke primarily for nicotine intake. Consequently, this study expects to observe gender differences in response to manipulating flavors and nicotine content in cigarettes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced Nicotine Non-Menthol (RNC) | Experimental | Study participants will be randomized from their own brand of menthol cigarettes to the reduced nicotine non menthol cigarettes (RNC: NRC 200; 0.07 mg nicotine yield cigarettes without menthol) during the 6 week experimental phase. |
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| Reduced Nicotine Menthol (RNC-Men) | Experimental | Study participants will be randomized from their own brand of menthol cigarettes to the reduced nicotine menthol cigarettes (RNC-Men: NRC 201; 0.07 mg reduced nicotine content menthol cigarettes) during the 6 week experimental phase. |
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| Conventional Nicotine Non-Menthol (CN) | Experimental | Study participants will be randomized from their own brand of menthol cigarettes to the regular/conventional nicotine non menthol cigarettes (CN: NRC 600; 0.8 mg nicotine content) during the 6 week experimental phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced Nicotine Non-Menthol (RNC) | Other | Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield without menthol. |
| Measure | Description | Time Frame |
|---|---|---|
| Gender differences and change in number of investigational tobacco product(s) smoked per day as assessed by the Timeline Follow-Back (TLFB) | Data analyses will include subjects from this study matched to female subjects from the parent study. | Baseline, 6 weeks, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gender differences and changes in craving as assessed by Minnesota Nicotine Withdrawal Scale (MNWS). | Baseline, 6 weeks, and 12 weeks | |
| Gender differences and changes in nicotine dependence as assessed by the Wisconsin Index of Smoking Dependence Motives (WISDM). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Oncken, MD, MPH | UConn Health | Principal Investigator |
| Ellen Dornelas, PhD | Hartford HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCONN Health Center | Farmington | Connecticut | 06030 | United States | ||
| Hartford Hospital |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Reduced Nicotine Menthol (RNC-Men) | Other | Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield with menthol. |
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| Conventional Nicotine Non-Menthol (CN) | Other | Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield. |
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| Baseline, 6 weeks, and 12 weeks |
| Gender differences and changes in nicotine dependence as assessed by the Fagerstrom Test of Nicotine Dependence (FTND) | Baseline, 6 weeks, and 12 weeks |
| Supertaster status as measured by genotyping for taster-receptor genes associated with taste behaviors. | Baseline |
| Hartford |
| Connecticut |
| 06102 |
| United States |