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Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00816231
Enrollment
244
Registered
2009-01-01
Start date
2006-05-08
Completion date
2019-06-20
Last updated
2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence

Keywords

Prevention Intervention, Alcohol, Tobacco, Nicotine, Craving, Cue Reactivity, Cross Cue Reactions

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.

Interventions

BEHAVIORALTobacco

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.

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.

OTHERPlacebo

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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Psychophysiological Reactivity Assessmentapproximately 5 weeks per participantTo 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

MeasureTime frameDescription
Alcohol Self-administration Assessmentapproximately 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026