Nicotine DependenceNCT00865254
Prize Reinforcement for Smoking Cessation
A study testing Standard Treatment, Traditional Contingency Management and Early Enhanced Contingency Management in people with Nicotine Dependence, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Standard Treatment, Traditional Contingency Management and Early Enhanced Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University, Jefferson Avenue Research Clinic
Detroit, Michigan, 48207
About this study
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.
Read the 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.
- Conditions
- Nicotine Dependence
- Being tested
- Standard Treatment, Traditional Contingency Management, Early Enhanced Contingency Management
- Keywords
- Nicotine Dependence, Smoking, Smoking Cessation, Contingency Management
- Medical subject headings
- Tobacco Use Disorder, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TreatmentBehavioural
Brief counseling for smoking cessation followed by continued brief supportive sessions and frequent monitoring of smoking cessation efforts.
Traditional Contingency ManagementBehavioural
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.
Early Enhanced Contingency ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Contingency Management | Experimental | Standard treatment plus prize based contingency management. Receives: 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. Receives: Behavioral: Early Enhanced Contingency Management |
| Standard Treatment | Active comparator | Counseling and monitoring of smoking cessation. Receives: Behavioral: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expired Carbon Monoxide
Measured: Baseline and treatment phases, 2-mont and 6-month follow up.
Secondary outcomes (2)
Self-reported smoking.
Measured: Baseline, throughout treatment, 2-month and 6-month follow up.
Cotinine levels.
Measured: Baseline, throughout treatment, 2-month and 6-month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startAug 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, David Ledgerwood, Wayne State University
- Investigators
- David M Ledgerwood, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865254
- Sponsor's protocol ID
- RDA021839A
- Other IDs
- R21DA021839, 1R21DA021839-01
- Status last verified
- Jun 2013
- First submitted
- 17 Mar 2009
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27547173
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prize Reinforcement for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00865254
- Acronym / sponsor ID
- RDA021839A
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine Dependence, Smoking, Smoking Cessation, Contingency Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional Contingency Management | Experimental | Behavioral: Traditional Contingency ManagementStandard treatment plus prize based contingency management. |
| Early Enhanced Contingency Management | Experimental | Behavioral: Early Enhanced Contingency ManagementPrize based contingency management with enhanced magnitude early in treatment and reduced magnitude later in treatment. |
| Standard Treatment | Active comparator | Behavioral: Standard TreatmentCounseling and monitoring of smoking cessation. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard TreatmentBrief counseling for smoking cessation followed by continued brief supportive sessions and frequent monitoring of smoking cessation efforts. | Behavioural | Standard Treatment |
| Traditional Contingency ManagementPrize 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. | Behavioural | Traditional Contingency Management |
| Early Enhanced Contingency ManagementPrize 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. | Behavioural | Early Enhanced Contingency Management |
Primary outcome
Expired Carbon Monoxide
Time frame: Baseline and treatment phases, 2-mont and 6-month follow up.
2 secondary outcomes
Self-reported smoking.
Time frame: Baseline, throughout treatment, 2-month and 6-month follow up.
Cotinine levels.
Time frame: Baseline, throughout treatment, 2-month and 6-month follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
- Derived from this study: PubMed 27547173Reid 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Ledgerwood, Ph.D. principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Treatment, Traditional Contingency Management and Early Enhanced Contingency Management in people with Nicotine Dependence, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expired Carbon Monoxide (time frame: Baseline and treatment phases, 2-mont and 6-month follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00865254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2013.