NCT00218452

Brief Summary

The purpose of this study is develop and test the success of a new smoking cessation intervention that includes a component to eliminate binge drinking.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Sep 2005

Typical duration for early_phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

2.2 years

First QC Date

September 16, 2005

Last Update Submit

April 6, 2015

Conditions

AdherenceTobacco Use CessationAlcohol & Drug UseNicotine Transdermal System

Keywords

Tobacco use cessation

Outcome Measures

Primary Outcomes (1)

  • Treatment attendance

    quantified as the percentage of sessions attended, will be summarized separately for each treatment group and compared between groups using the rank sum test. One summary will be performed for the percentage of sessions attended face-to-face and a second summary will be performed for the percentage of sessions attended either face-to-face or via telephone.

    week 12 and week 24

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL
Behavioral: Lifestyle counseling

Interventions

Lifestyle counselingBEHAVIORAL

assigned to a 6-week individual behavioral treatment involving: 1) a novel brief office intervention for cigarette smoking that includes a treatment component intended to eliminate binge drinking

Lifestyle counseling

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (1) Aged 18-25 years. (2) Enrolled as a student at a two or four year technical or non-technical college or university. (3) Smoked \> 10 or more cigarettes per day during the past 6 months. (4) Binge drank on \> 2 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. (5) Able to participate fully in all aspects of the intervention and keep all scheduled appointments. (6) Willing to participate in 6 months of follow-up. (7) Willing to stop smoking and use nicotine patch therapy. (8) Willing to refrain from participating in additional smoking interventions for the duration of the study. (9) Provide written informed consent. (10) General good health as determined by screening physician or registered nurse.

You may not qualify if:

  • (1) Current (past 90 days) alcohol dependence as assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders, Alcohol Dependence Module. (2) Current (past 12 months) non-nicotine or alcohol drug dependence as assessed by a Drug Abuse Screening Test-20 score of \> 6. (3) 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. (4) Current use (past 30 days) of nicotine containing medication or tobacco products other than cigarettes. (5) Current use (past 30 days) of any other smoking cessation treatment involving behavioral or pharmacological interventions. (6) 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, or evidence of severe chronic dermatosis.
  • (7) Currently pregnant or breast feeding, or likely to become pregnant during the nicotine patch phase.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of North Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Tobacco Use CessationSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Steven C Ames, Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2007

Study Completion

April 1, 2008

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(3)