Drug /Cue Interactions In Alcohol-Tobacco Comorbidity
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Purpose
The purpose of this study is to determine how people react to different combinations of alcohol and nicotine.
| Condition | Intervention |
|---|---|
|
Nicotine Dependence |
Behavioral: Tobacco Research and Intervention Program |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Drug /Cue Interactions In Alcohol-Tobacco Comorbidity |
- Psychophysiological Reactivity Assessment [ Time Frame: approximately 5 weeks per participant ] [ Designated as safety issue: No ]To assess cravings and psychophysiological reactivity elicited by alcohol, smoking, and neutral cues following acute intake of alcohol and nicotine among individuals across a broad range of alcohol and cigarette use patterns (Study 1).
- Alcohol Self-administration Assessment [ Time Frame: approximately 5 weeks per participant. ] [ Designated as safety issue: No ]To assess alcohol self-administration upon exposure to alcohol or smoking-related cues following acute intake of alcohol, nicotine, or both drugs among individuals across a broad range of alcohol and cigarette use patterns (Study 2).
| Enrollment: | 243 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Drug/Cue Interactions |
Behavioral: Tobacco Research and Intervention Program
Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving tobacco and alcohol with brief summary at the end of the last session.
Other Name: TRIP
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| Principal Investigator: | David Drobes, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00816231 History of Changes |
| Other Study ID Numbers: | MCC-14671 |
| Study First Received: | December 31, 2008 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
|
Prevention Intervention Alcohol Tobacco Nicotine |
Craving Cue Reactivity Cross Cue Reactions |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Ethanol Anti-Infective Agents, Local Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013