Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

NCT00816231 | Completed

• 1 other identifier: MCC-14671
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nicotine Dependence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Alcohol Self-administration Assessment

  approximately 5 weeks per participant.

Study Arms (4)

Alcohol and Nicotine Group

EXPERIMENTAL

Alcohol and Nicotine Drug/Cue Interactions

Behavioral: Tobacco; Other: Alcoholic Beverage

Alcohol Only Group

ACTIVE COMPARATOR

Alcohol Only Drug/Cue Interactions

Other: Alcoholic Beverage; Other: Placebo

Nicotine Only Group

ACTIVE COMPARATOR

Nicotine Only Drug/Cue Interactions

Behavioral: Tobacco; Other: Placebo

Placebo and Placebo Group

PLACEBO COMPARATOR

Placebo Only Drug/Cue Interactions

Other: Placebo

Interventions

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.

Alcohol and Nicotine Group; Nicotine Only Group

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.

Alcohol Only Group; Alcohol and Nicotine Group

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.

Alcohol Only Group; Nicotine Only Group; Placebo and Placebo Group

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• English speaking persons who exhibit a range of alcohol consumption and smoking patterns.
• Signed written consent form.

You may not qualify if:

• Females who are pregnant, nursing, or not using effective methods of birth control will be excluded from participating.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Products; Alcoholic Beverages

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David Drobes, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2008
• First Posted: January 1, 2009
• Study Start: May 8, 2006
• Primary Completion: March 1, 2014
• Study Completion: June 20, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

US (1)