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Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

H. Lee Moffitt Cancer Center and Research Institute logo

H. Lee Moffitt Cancer Center and Research Institute

Status

Completed

Conditions

Nicotine Dependence

Treatments

Behavioral: Tobacco
Other: Alcoholic Beverage
Other: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00816231
MCC-14671

Details and patient eligibility

About

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

Full 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.

Enrollment

244 patients

Sex

All

Ages

21 to 55 years old

Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

244 participants in 4 patient groups, including a placebo group

Alcohol and Nicotine Group
Experimental group
Description:
Alcohol and Nicotine Drug/Cue Interactions
Treatment:
Other: Alcoholic Beverage
Behavioral: Tobacco
Alcohol Only Group
Active Comparator group
Description:
Alcohol Only Drug/Cue Interactions
Treatment:
Other: Placebo
Other: Alcoholic Beverage
Nicotine Only Group
Active Comparator group
Description:
Nicotine Only Drug/Cue Interactions
Treatment:
Other: Placebo
Behavioral: Tobacco
Placebo and Placebo Group
Placebo Comparator group
Description:
Placebo Only Drug/Cue Interactions
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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