| Registry | NCT00816231 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 244 (Actual) |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute (Other); collaborators: National Institutes of Health (NIH) |
| Conditions | Nicotine Dependence |
| Interventions | Tobacco, Alcoholic Beverage, Placebo (Behavioral, other) |
| Dates | start 2006-05-08, primary completion 2014-03-01, completion 2019-06-20, first posted 2009-01-01, last updated 2019-09-06 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Nicotine Dependence All trials of Tobacco All trials of Alcoholic Beverage
The purpose of this study is to determine how people react to different combinations of alcohol and nicotine.
The present project will improve and expand upon previously published work in several ways. First, Study 1 will assess reactivity to alcohol and smoking cues in the same session. Second, both studies will include within-subjects design factors to manipulate alcohol and nicotine intake, as well as cue types. Third, craving indices will represent three important response domains: subjective, physiological, and behavioral (e.g., Niaura et al., 1991). Fourth, each study will evaluate a range of drinkers and smokers, which will provide maximal information concerning influences on alcohol and smoking cue reactivity across various subject populations. The proposed studies are not only important from a theory development perspective, but they will provide an excellent foundation for future laboratory-based and clinical research.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Alcohol and Nicotine Group | Experimental | Behavioral: Tobacco; Other: Alcoholic Beverage | Alcohol and Nicotine Drug/Cue Interactions |
| Alcohol Only Group | Active comparator | Other: Alcoholic Beverage; Other: Placebo | Alcohol Only Drug/Cue Interactions |
| Nicotine Only Group | Active comparator | Behavioral: Tobacco; Other: Placebo | Nicotine Only Drug/Cue Interactions |
| Placebo and Placebo Group | Placebo comparator | Other: Placebo | Placebo Only Drug/Cue Interactions |
Sex: All, ages: 21 Years to 55 Years, accepts healthy volunteers
Inclusion Criteria: * English speaking persons who exhibit a range of alcohol consumption and smoking patterns. * Signed written consent form. Exclusion Criteria: * Females who are pregnant, nursing, or not using effective methods of birth control will be excluded from participating.
| Facility | City | Country | Status |
|---|---|---|---|
| H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida | United States |