Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

Nicotine Dependence Clinical Trial

Official title:

Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816231
• Other study ID #: MCC-14671
• Status: Completed
• Phase: N/A
• Start date: May 8, 2006
• Est. completion date: June 20, 2019

Study information

• Verified date: September 2019
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: June 20, 2019
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Tobacco
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.

Other:
• Alcoholic Beverage
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
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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychophysiological Reactivity Assessment	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).	approximately 5 weeks per participant
Secondary	Alcohol Self-administration Assessment	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).	approximately 5 weeks per participant.

External Links

•   Moffitt Cancer Center Clinical Trials website