NCT01184261

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

2.5 years

First QC Date

August 17, 2010

Last Update Submit

March 24, 2014

Conditions

for Cigarette Smoking and Binge Drinking Cessation

Outcome Measures

Primary Outcomes (1)

  • Biochemically-confirmed 7-day point prevalence tobacco abstinence

    At week 24

Secondary Outcomes (2)

  • Effect of the integrated intervention on binge drinking

    At week 24

  • Possible mediators of the intervention

    At week 24

Study Arms (2)

Arm I

EXPERIMENTAL

Patients attend behavioral sessions for smoking and binge drinking cessation over 30 minutes once weekly in weeks 1-6.

Behavioral: behavioral intervention

Arm II

EXPERIMENTAL

Patients attend behavioral sessions for smoking cessation over 30 minutes once weekly in weeks 1-6.

Behavioral: behavioral intervention

Interventions

behavioral interventionBEHAVIORAL

8 session behavioral intervention.

Also known as: Behavior or Life Style Modifications, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment
Arm IArm II

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, United States

Location

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Steven Ames

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 18, 2010

Study Start

August 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

US(1)