This trial is active, not recruiting.

Condition nicotine dependence
Treatment tobacco research and intervention program
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator National Institutes of Health (NIH)
Start date May 2006
End date March 2014
Trial size 244 participants
Trial identifier NCT00816231, MCC-14671


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose prevention
tobacco research and intervention program TRIP
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.

Primary Outcomes

Psychophysiological Reactivity Assessment
time frame: approximately 5 weeks per participant

Secondary Outcomes

Alcohol Self-administration Assessment
time frame: approximately 5 weeks per participant.

Eligibility Criteria

Male or female participants from 21 years up to 55 years old.

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.

Additional Information

Official title Drug /Cue Interactions In Alcohol-Tobacco Comorbidity
Principal investigator David Drobes, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.