Prize Reinforcement for Smoking Cessation
Primary Purpose
Nicotine Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Treatment
Traditional Contingency Management
Early Enhanced Contingency Management
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence focused on measuring Nicotine Dependence, Smoking, Smoking Cessation, Contingency Management
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Wayne State University, Jefferson Avenue Research Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Traditional Contingency Management
Early Enhanced Contingency Management
Standard Treatment
Arm Description
Standard treatment plus prize based contingency management.
Prize based contingency management with enhanced magnitude early in treatment and reduced magnitude later in treatment.
Counseling and monitoring of smoking cessation.
Outcomes
Primary Outcome Measures
Expired Carbon Monoxide
Secondary Outcome Measures
Self-reported smoking.
Cotinine levels.
Full Information
NCT ID
NCT00865254
First Posted
March 17, 2009
Last Updated
June 27, 2013
Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00865254
Brief Title
Prize Reinforcement for Smoking Cessation
Official Title
Prize Reinforcement for Smoking Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Nicotine Dependence, Smoking, Smoking Cessation, Contingency Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional Contingency Management
Arm Type
Experimental
Arm Description
Standard treatment plus prize based contingency management.
Arm Title
Early Enhanced Contingency Management
Arm Type
Experimental
Arm Description
Prize based contingency management with enhanced magnitude early in treatment and reduced magnitude later in treatment.
Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
Counseling and monitoring of smoking cessation.
Intervention Type
Behavioral
Intervention Name(s)
Standard Treatment
Intervention Description
Brief counseling for smoking cessation followed by continued brief supportive sessions and frequent monitoring of smoking cessation efforts.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Contingency Management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Early Enhanced Contingency Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Expired Carbon Monoxide
Time Frame
Baseline and treatment phases, 2-mont and 6-month follow up.
Secondary Outcome Measure Information:
Title
Self-reported smoking.
Time Frame
Baseline, throughout treatment, 2-month and 6-month follow up.
Title
Cotinine levels.
Time Frame
Baseline, throughout treatment, 2-month and 6-month follow up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Ledgerwood, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University, Jefferson Avenue Research Clinic
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48207
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27547173
Citation
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.
Results Reference
derived
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Prize Reinforcement for Smoking Cessation
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