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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA036486-01 | 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 women of reproductive age, a vulnerable population identified by the FDA in need of further research.
Study is designed to address the following questions that have been outlined by the FDA as particular areas of interest:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced Nicotine Content -Non Menthol | Experimental | Switch from own brand of cigarette to SPECTRUM research cigarettes (NRC 200-Reduced Nicotine Content cigarette) which contain 0.07mg nicotine yield without menthol. |
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| Reduced Nicotine Content- Menthol | Experimental | Switch from own brand of cigarette to Reduced Nicotine Research Cigarettes which contain 0.07mg nicotine yield with Menthol |
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| Conventional Nicotine Content- Menthol | Active Comparator | Allow own brand of Conventional Nicotine-Menthol Cigarette. No research cigarettes used. |
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| Conventional Nicotine Content- Non Menthol | Experimental | Switch from own brand of cigarette to SPECTRUM research cigarette (NRC-600 Conventional Nicotine )which contains conventional nicotine yield. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced Nicotine Content- Non Menthol | Other | Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol. |
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| Measure | Description | Time Frame |
|---|---|---|
| The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence. | Alter the nicotine and menthol concentrations of cigarettes administered to subjects as randomized. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicant Exposure | Examine the effects of reduced nicotine and menthol removal on toxicant exposure for the outcomes-- cotinine, exhaled carbon monoxide, and urine carcinogens and other tobacco specific nitrosamines. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarette content manipulations effect on a model mediating usage | Examine cigarette content manipulation (nicotine reduction and menthol removal) as independent variables and the number of cigarettes recorded daily as dependent variable..Measures that will be tested for include subscales of the cigarette evaluations as well as craving, affect and mood, and self-confidence | 12 Weeks |
Inclusion criteria are:
Exclusion criteria are:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl A Oncken, MD MPH | UCONN Health Center | 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 |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Reduced Nicotine Content- Menthol | Other | Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol |
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| Conventional Nicotine Content- Menthol | Other | Allow own brand of Conventional Nicotine-Menthol Cigarette |
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| Conventional Nicotine Content- Non Menthol | Other | Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield. |
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| Effect of taster status | To explore the moderating effects of supertasters with menthol assignments to predict compliance with treatment, cigarette taste and aversion. A logistic model will be used to predict post-treatment abstinence. The interaction between supertaster and menthol will test for the moderating effect. | 12 Weeks |
| Hartford |
| Connecticut |
| 06102 |
| United States |