Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

Not Applicable

Completed

• Conditions: Nicotine Dependence
• Interventions: Behavioral: Tobacco; Other: Alcoholic Beverage; Other: Placebo

• Registration Number: NCT00816231
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-05-08
• Study First Submitted: 2008-12-31
• Study First Submitted QC: 2008-12-31
• Study First Posted: 2009-01-01
• Primary Completion: 2014-03
• Study Completion: 2019-06-20
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alcohol and Nicotine Group	Alcoholic Beverage	Alcohol and Nicotine Drug/Cue Interactions
Nicotine Only Group	Tobacco	Nicotine Only Drug/Cue Interactions
Alcohol Only Group	Placebo	Alcohol Only Drug/Cue Interactions
Alcohol and Nicotine Group	Tobacco	Alcohol and Nicotine Drug/Cue Interactions
Alcohol Only Group	Alcoholic Beverage	Alcohol Only Drug/Cue Interactions
Placebo and Placebo Group	Placebo	Placebo Only Drug/Cue Interactions
Nicotine Only Group	Placebo	Nicotine Only Drug/Cue Interactions

Primary Outcome Measures

Name	Time	Method
Psychophysiological Reactivity Assessment	approximately 5 weeks per participant	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).

Secondary Outcome Measures

Name	Time	Method
Alcohol Self-administration Assessment	approximately 5 weeks per participant.	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).

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States