Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

H. Lee Moffitt Cancer Center and Research Institute244 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

244

Conditions

Nicotine Dependence

Interventions

TobaccoBEHAVIORAL

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.

Alcoholic BeverageOTHER

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.

PlaceboOTHER

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: approximately 5 weeks per participant

Secondary Outcomes

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).

Time frame: approximately 5 weeks per participant.

Data from ClinicalTrials.gov

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