A Study of a Behavioral Intervention for Both Cigarette Smoking and Binge Drinking in Young Adults

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 10-000432
    NCT ID: NCT01184261
    Sponsor Protocol Number: 10-000432

About this study

 Nicotine patches and behavioral therapy may help reduce cigarette smoking and binge drinking in young adults.This randomized clinical trial studies nicotine patches with or without behavioral therapy in reducing cigarette smoking and binge drinking in young adults.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

This study has been completed

Inclusion Criteria     

  • Age 18–30 years
  • Smoked an average of greater than or equal to 1 or more cigarettes per day during the past 6 months
  • Binge drank on an average of  > 1 occasions per month during the past 3 months
    • Binge drinking is defined as consumption of > 5 standardized alcoholic drinks in a row for males or > 4  drinks in a row for females
  • Able to participate fully in all aspects of the intervention and keep all scheduled appointments
  • Willing to participate in 6 months of follow-up
  • Willing to stop smoking and use nicotine patch therapy
  • Willing to refrain from participating in additional smoking interventions for the duration of the study
  • Provide written informed consent.

Exclusion Criteria:      

  • Current (past 90 days) alcohol dependence as assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders, Alcohol Dependence Module
  • Current (past 12 months) non-nicotine or alcohol drug dependence as assessed by a Drug Abuse Screening Test-20 score of > 6
  • Current elevation of depressive symptoms (past 2 weeks) that would be indicative of clinical depression as assessed by a Beck Depression Inventory-II score of > 20
  • Current use (past 30 days) of nicotine containing medication or frequent use (> 10 occasions per month) of tobacco products other than cigarettes
  • Current use (past 30 days) of any other smoking cessation treatment involving behavioral or pharmacological interventions
  • Any medical condition that would preclude use of the nicotine patch including
    • current unstable angina
    • recent history (past 30 days) of myocardial infarction or stroke
    • history of severe skin allergies
    • evidence of severe chronic dermatosis
  • Currently pregnant or breast feeding, or likely to become pregnant during the nicotine patch phase
  • A member of the household has participated in the trial

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Steven Ames, Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20315195

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