NCT01056588

Brief Summary

The primary objective of this research is to evaluate the effectiveness of this type of smoking cessation program by comparing a treatment group with a control group. A secondary objective of this research is to explore relations between impulsive behavior and smoking-cessation success among treatment-seeking teens participating in a quit-smoking program. Hypothesis 1. A greater proportion of the participants in the treatment condition will be verified as abstinent from smoking during the course of treatment than participants of the control condition. Hypothesis 2. It is hypothesized that teens who do not successfully stop smoking (or who drop out of the treatment program) will be more impulsive (from measures taken just prior to treatment) than those who do successfully stop or significantly reduce rate of smoking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

4.9 years

First QC Date

January 25, 2010

Last Update Submit

July 18, 2019

Conditions

Keywords

adolescent smokingContingency managementQuit smoking

Outcome Measures

Primary Outcomes (1)

  • The primary outcome for this research will be smoking treatment outcomes (reductions or abstinence) compared across the treatment- and control-condition arms.

    approximately 9.5 months

Secondary Outcomes (1)

  • The secondary outcome for this research will involve the use of pre-treatment assessments of impulsive behavior as predictors of treatment response at the end of the treatment for both conditions and also during followup.

    approximately 9.5 months

Study Arms (2)

Control Condition

PLACEBO COMPARATOR

In this condition, participants will receive reinforcement for timely breath samples with no contingency for a specific breath CO level.

Behavioral: Control condition

CO-Contingent

ACTIVE COMPARATOR

In this condition, participants will receive reinforcements contingent on submitting breath samples at CO levels indicating reductions or abstinence from smoking.

Behavioral: CO-Contingent

Interventions

CO-ContingentBEHAVIORAL

In this 42 day condition, participants will receive monetary reinforcements contingent on submitting breath samples at CO levels indicating reductions or abstinence from smoking (4ppm).

CO-Contingent

In this condition, participants will receive monetary reinforcement for timely breath samples with no contingency for a specific breath CO level

Control Condition

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages of 13-19
  • Have a breath CO level of at least 10ppm
  • Smoke at least 2 cigarettes per day
  • Live in Columbus, OH area

You may not qualify if:

  • Adolescents must be English-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Study Officials

  • Brady Reynolds, PhD

    Nationwide Children's Hopsital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 26, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 22, 2019

Record last verified: 2019-07

Locations