Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

NCT00816231 — Not applicable, Completed, 244 participants, H. Lee Moffitt Cancer Center and Research Institute

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RegistryNCT00816231
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, prevention
Enrollment244 (Actual)
SponsorH. Lee Moffitt Cancer Center and Research Institute (Other); collaborators: National Institutes of Health (NIH)
ConditionsNicotine Dependence
InterventionsTobacco, Alcoholic Beverage, Placebo (Behavioral, other)
Datesstart 2006-05-08, primary completion 2014-03-01, completion 2019-06-20, first posted 2009-01-01, last updated 2019-09-06
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Nicotine Dependence All trials of Tobacco All trials of Alcoholic Beverage

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Alcohol and Nicotine GroupExperimentalBehavioral: Tobacco; Other: Alcoholic BeverageAlcohol and Nicotine Drug/Cue Interactions
Alcohol Only GroupActive comparatorOther: Alcoholic Beverage; Other: PlaceboAlcohol Only Drug/Cue Interactions
Nicotine Only GroupActive comparatorBehavioral: Tobacco; Other: PlaceboNicotine Only Drug/Cue Interactions
Placebo and Placebo GroupPlacebo comparatorOther: PlaceboPlacebo Only Drug/Cue Interactions
  • Tobacco (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 (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 (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.

+Outcome measures

Primary outcomes

  • Psychophysiological Reactivity Assessment [approximately 5 weeks per participant]: 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 outcomes

  • Alcohol Self-administration Assessment [approximately 5 weeks per participant.]: 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).

+Eligibility

Sex: All, ages: 21 Years to 55 Years, accepts 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.

+Locations (1)

FacilityCityCountryStatus
H. Lee Moffitt Cancer Center & Research InstituteTampa, FloridaUnited States

+Investigators

  • David Drobes, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute