Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prize Reinforcement for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Ledgerwood, Wayne State University
ClinicalTrials.gov Identifier:
NCT00865254
First received: March 17, 2009
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Nicotine Dependence
Behavioral: Standard Treatment
Behavioral: Traditional Contingency Management
Behavioral: Early Enhanced Contingency Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prize Reinforcement for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Expired Carbon Monoxide [ Time Frame: Baseline and treatment phases, 2-mont and 6-month follow up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported smoking. [ Time Frame: Baseline, throughout treatment, 2-month and 6-month follow up. ] [ Designated as safety issue: No ]
  • Cotinine levels. [ Time Frame: Baseline, throughout treatment, 2-month and 6-month follow up. ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: August 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Traditional Contingency Management
Standard treatment plus prize based contingency management.
Behavioral: 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 (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.
Experimental: Early Enhanced Contingency Management
Prize based contingency management with enhanced magnitude early in treatment and reduced magnitude later in treatment.
Behavioral: Early Enhanced 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.
Active Comparator: Standard Treatment
Counseling and monitoring of smoking cessation.
Behavioral: Standard Treatment
Brief counseling for smoking cessation followed by continued brief supportive sessions and frequent monitoring of smoking cessation efforts.

Detailed Description:

Contingency management (CM) treatments are efficacious in reducing substance use. A relatively new approach, called prize-based CM, which uses prizes to reinforce substance abstinence, is effective in decreasing certain types of substance use, but its efficacy has not been evaluated in the treatment of cigarette smoking. One purpose of the current study is to assess the efficacy of a prize reinforcement intervention for reducing cigarette smoking. A second purpose is to test the differential efficacy of two schedules of reinforcement, using cigarette smoking as an exemplar. We will randomly assign 110 patients to one of three conditions: 1) Standard treatment; 2) Traditional prize reinforcement; or 3) Early-treatment enhanced prize reinforcement. Patients in each condition will receive counseling for their smoking based on current standard of care guidelines. All patients will participate in a one-week baseline period, followed by a four-week intervention. Throughout both phases, each patient will meet with a research assistant twice daily to provide carbon monoxide (CO) samples. Patients in the prize reinforcement conditions will earn the chance to win prizes when they provide negative CO samples (i.e., < 6ppm). They will also earn bonus draws if they provide negative cotinine samples (i.e., <100ng/ml) after weekends. Patients in the Traditional CM condition will have at least a 50% chance of winning a prize for each negative sample with escalating chances for successive negative samples. Patients in the Enhanced condition will have the opportunity to earn the same overall number of draws and magnitude of reinforcement, but the schedule of reinforcement will differ. For the first week of the CM phase, these patients will have a 100% chance of winning prizes, but in the latter 3 weeks, overall probability of reinforcement will be decreased to 34%. Patients will also undergo 2- and 6-month follow-up assessments. Primary outcome measures will be longest duration of continuous abstinence and mean number of days of abstinence. We predict that the prize reinforcement will reduce cigarette smoking to a greater extent than standard treatment. We also predict that the Enhanced CM condition will lead to greater reductions in cigarette smoking relative to the Traditional CM condition, and that these changes may result in longer sustained abstinence from smoking throughout the study period.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Have current severe, uncontrolled psychiatric disorders (i.e., acute suicidality or psychosis);
  2. Have current substance dependence, other than nicotine or caffeine dependence;
  3. Are in recovery for pathological gambling; or
  4. Are already participating in other behavioral or medication smoking cessation programs.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865254

Locations
United States, Michigan
Wayne State University, Jefferson Avenue Research Clinic
Detroit, Michigan, United States, 48207
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: David M Ledgerwood, Ph.D. Wayne State University
  More Information

No publications provided

Responsible Party: David Ledgerwood, Assistant Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT00865254     History of Changes
Other Study ID Numbers: RDA021839A, R21DA021839, 1R21DA021839-01
Study First Received: March 17, 2009
Last Updated: June 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Wayne State University:
Nicotine Dependence
Smoking
Smoking Cessation
Contingency Management

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 27, 2014