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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014