NCT00865254

Brief Summary

Nicotine dependence is prevalent in society, cigarette smoking is associated with several known health risks, and most dependent individuals find it very difficult to stop smoking cigarettes. The present study will test the efficacy of a behavioral smoking cessation treatment, prize-based contingency management, that has not undergone rigorous study with respect to smoking, it but has demonstrated efficacy in reducing use of other substances (e.g. cocaine). If efficacious, prize-based contingency management would add to our repertoire of efficacious smoking cessation treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

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

Study Start

First participant enrolled

August 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

June 28, 2013

Status Verified

June 1, 2013

Enrollment Period

3.9 years

First QC Date

March 17, 2009

Last Update Submit

June 27, 2013

Conditions

Keywords

Nicotine DependenceSmokingSmoking CessationContingency Management

Outcome Measures

Primary Outcomes (1)

  • Expired Carbon Monoxide

    Baseline and treatment phases, 2-mont and 6-month follow up.

Secondary Outcomes (2)

  • Self-reported smoking.

    Baseline, throughout treatment, 2-month and 6-month follow up.

  • Cotinine levels.

    Baseline, throughout treatment, 2-month and 6-month follow up.

Study Arms (3)

Traditional Contingency Management

EXPERIMENTAL

Standard treatment plus prize based contingency management.

Behavioral: Traditional Contingency Management

Early Enhanced Contingency Management

EXPERIMENTAL

Prize based contingency management with enhanced magnitude early in treatment and reduced magnitude later in treatment.

Behavioral: Early Enhanced Contingency Management

Standard Treatment

ACTIVE COMPARATOR

Counseling and monitoring of smoking cessation.

Behavioral: Standard Treatment

Interventions

Brief counseling for smoking cessation followed by continued brief supportive sessions and frequent monitoring of smoking cessation efforts.

Standard Treatment

Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking. Prize draws result in incentives on an intermittent schedule (50% of draws are prizes). Participants are also provided with brief counseling for smoking cessation followed by continued brief supportive sessions and frequent monitoring of smoking cessation efforts.

Traditional Contingency Management

Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking. Prize draws result in incentives on an intermittent schedule (100% of draws are prizes in week 1; 33% are prizes in weeks 2-4). Participants are also provided with brief counseling for smoking cessation followed by continued brief supportive sessions and frequent monitoring of smoking cessation efforts.

Early Enhanced Contingency Management

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A current Fagerstrom scale score of 6 or greater;
  • Age 13 years old or older (Under age 18, parental consent is required);
  • Able to read and understand English.

You may not qualify if:

  • Have current severe, uncontrolled psychiatric disorders (i.e., acute suicidality or psychosis);
  • Have current substance dependence, other than nicotine or caffeine dependence;
  • Are in recovery for pathological gambling; or
  • Are already participating in other behavioral or medication smoking cessation programs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University, Jefferson Avenue Research Clinic

Detroit, Michigan, 48207, United States

Location

Related Publications (1)

  • Reid HH, Ledgerwood DM. Depressive symptoms affect changes in nicotine withdrawal and smoking urges throughout smoking cessation treatment: Preliminary results. Addict Res Theory. 2016;24(1):48-53. doi: 10.3109/16066359.2015.1060967. Epub 2015 Jun 26.

MeSH Terms

Conditions

Tobacco Use DisorderSmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorHealth Behavior

Study Officials

  • David M Ledgerwood, Ph.D.

    Wayne State University

    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
Assistant Professor

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 19, 2009

Study Start

August 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

June 28, 2013

Record last verified: 2013-06

Locations