Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00816231
First received: December 31, 2008
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Nicotine Dependence
Behavioral: Tobacco Research and Intervention Program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Psychophysiological Reactivity Assessment [ Time Frame: approximately 5 weeks per participant ] [ Designated as safety issue: No ]
    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 [ Time Frame: approximately 5 weeks per participant. ] [ Designated as safety issue: No ]
    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).


Enrollment: 244
Study Start Date: May 2006
Estimated Study Completion Date: December 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug/Cue Interactions Behavioral: Tobacco Research and Intervention Program
Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving tobacco and alcohol with brief summary at the end of the last session.
Other Name: TRIP

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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816231

Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: David Drobes, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00816231     History of Changes
Other Study ID Numbers: MCC-14671
Study First Received: December 31, 2008
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Prevention Intervention
Alcohol
Tobacco
Nicotine
Craving
Cue Reactivity
Cross Cue Reactions

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014