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Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tobacco
Alcoholic Beverage
Placebo
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nicotine Dependence focused on measuring Prevention Intervention, Alcohol, Tobacco, Nicotine, Craving, Cue Reactivity, Cross Cue Reactions

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • H. Lee Moffitt Cancer Center & Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Alcohol and Nicotine Group

Alcohol Only Group

Nicotine Only Group

Placebo and Placebo Group

Arm Description

Alcohol and Nicotine Drug/Cue Interactions

Alcohol Only Drug/Cue Interactions

Nicotine Only Drug/Cue Interactions

Placebo Only Drug/Cue Interactions

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
December 31, 2008
Last Updated
September 5, 2019
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00816231
Brief Title
Drug /Cue Interactions In Alcohol-Tobacco Comorbidity
Official Title
Drug /Cue Interactions In Alcohol-Tobacco Comorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 8, 2006 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Prevention Intervention, Alcohol, Tobacco, Nicotine, Craving, Cue Reactivity, Cross Cue Reactions

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcohol and Nicotine Group
Arm Type
Experimental
Arm Description
Alcohol and Nicotine Drug/Cue Interactions
Arm Title
Alcohol Only Group
Arm Type
Active Comparator
Arm Description
Alcohol Only Drug/Cue Interactions
Arm Title
Nicotine Only Group
Arm Type
Active Comparator
Arm Description
Nicotine Only Drug/Cue Interactions
Arm Title
Placebo and Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo Only Drug/Cue Interactions
Intervention Type
Behavioral
Intervention Name(s)
Tobacco
Intervention Description
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
Other
Intervention Name(s)
Alcoholic Beverage
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psychophysiological Reactivity Assessment
Description
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 Outcome Measure Information:
Title
Alcohol Self-administration Assessment
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Drobes, Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

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Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

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