Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

NCT ID: NCT00816231

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-08

Study Completion Date

2019-06-20

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.

Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Alcohol and Nicotine Group

Alcohol and Nicotine Drug/Cue Interactions

Group Type EXPERIMENTAL

Tobacco

Intervention Type BEHAVIORAL

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 Beverage

Intervention Type OTHER

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.

Alcohol Only Group

Alcohol Only Drug/Cue Interactions

Group Type ACTIVE_COMPARATOR

Alcoholic Beverage

Intervention Type OTHER

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.

Placebo

Intervention Type OTHER

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.

Nicotine Only Group

Nicotine Only Drug/Cue Interactions

Group Type ACTIVE_COMPARATOR

Tobacco

Intervention Type BEHAVIORAL

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.

Placebo

Intervention Type OTHER

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.

Placebo and Placebo Group

Placebo Only Drug/Cue Interactions

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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Tobacco

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.

Intervention Type BEHAVIORAL

Alcoholic Beverage

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.

Intervention Type OTHER

Placebo

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.

Intervention Type OTHER

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Drobes, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

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H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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MCC-14671

Identifier Type: -

Identifier Source: org_study_id

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