Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

Study Overview
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Brief Summary
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The purpose of this study is to determine how people react to different combinations of alcohol and nicotine.

Detailed Description
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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.

Official Title
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Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Behavioral: Tobacco
* Other: Alcoholic Beverage
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcohol and Nicotine Group<br>Alcohol and Nicotine Drug/Cue Interactions | Behavioral: Tobacco<br>* Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving tobacco with brief summary at the end of the last session.<br>Other: Alcoholic Beverage<br>* Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving and alcohol with brief summary at the end of the last session.<br>|
| Active Comparator: Alcohol Only Group<br>Alcohol Only Drug/Cue Interactions | Other: Alcoholic Beverage<br>* Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving and alcohol with brief summary at the end of the last session.<br>Other: Placebo<br>* Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving placebo with brief summary at the end of the last session.<br>|
| Active Comparator: Nicotine Only Group<br>Nicotine Only Drug/Cue Interactions | Behavioral: Tobacco<br>* Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving tobacco with brief summary at the end of the last session.<br>Other: Placebo<br>* Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving placebo with brief summary at the end of the last session.<br>|
| Placebo Comparator: Placebo and Placebo Group<br>Placebo Only Drug/Cue Interactions | Other: Placebo<br>* Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving placebo with brief summary at the end of the last session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychophysiological Reactivity Assessment | 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). | approximately 5 weeks per participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Self-administration Assessment | 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). | approximately 5 weeks per participant. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention Intervention, Alcohol, Tobacco, Nicotine, Craving, Cue Reactivity, Cross Cue Reactions