Contingency Management for Smoking Cessation

Study Overview
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Brief Summary
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The prevalence of smoking in the homeless population (70%) is over 4 times that of the general population (15%). Homeless adults have not experienced similar declines in tobacco use as the general population has over the past three decades. Homeless adults are interested in smoking cessation and make quit attempts, but are less successful in quitting smoking than the general population. Trials of group behavioral counseling and pharmacotherapy for smoking cessation have not led to substantial long-term abstinence (i.e., abstinence for 6 months or more), suggesting that these interventions alone are insufficient to improve quit rates among homeless adults. Many homeless adults seek health care in safety net clinics; these clinics could bring cessation interventions to scale. Contingency management is a powerful behavior change intervention that reinforces positive health behaviors through the provision of modest incentives (e.g., cash). In this pilot randomized controlled trial, the investigator will test the feasibility and acceptability of a contingency management intervention that provides incentives for smoking cessation for people experiencing homelessness.

Detailed Description
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In this pilot randomized controlled trial (RCT), the investigator will (1) adapt a known-efficacious extended CM cessation intervention to a novel population and setting, with the ultimate goal of increasing long-term abstinence among homeless adults seeking care in safety net health clinics, (2) develop a corresponding RCT protocol, and (3) conduct a pilot RCT to assess the feasibility and acceptability of the RCT. If the pilot RCT is feasible and acceptable, the investigator will test the adapted intervention in a subsequently-funded, full-scale RCT. Primary Objectives: Assess feasibility and acceptability of a CM intervention through: Measuring biochemically-verified point prevalence abstinence at 6 months follow-up. Measuring participant adherence to the protocol. Gathering information on the number of visits attended. Assessing the retention protocol. Secondary Objectives Assess feasibility and acceptability of a CM intervention through: Biochemically-verified 7-day point months follow-up at 3 months. Prolonged abstinence at 3 months and 6 months follow-up. Point-prevalent abstinence at 12 months

Official Title
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Randomized Trial of a Contingency Management Smoking Cessation Intervention for Homeless Adults

Conditions
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Smoking, Tobacco, Smoking Cessation, Smoking Reduction

Intervention / Treatment
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* Behavioral: Contingency Management - Increasing
* Behavioral: Fixed payments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are 18 years or older Engaged in care at the Tom Waddell Urban Health Center (TWUHC) Meet criteria for homelessness as defined by the Homeless Emergency Assistance and Rapid Transition to Housing Act Are current smokers (smoked at least 100 cigarettes in lifetime, smoked daily in the past 7 days and at least 5 cigarettes per day, verified by expired Carbon Monoxide (CO) >= 8 parts per million (ppm)) Have an intention to quit smoking within the next six months Are attending on-site smoking cessation counseling provided by the behavioral counselors Are English proficient Are able to provide informed consent. Patients who are interested in participating but not enrolled in counseling services will be encouraged to engage in counseling sessions at the time of enrollment. Exclusion Criteria: 1. Are unable to take nicotine replacement therapy (e.g., pregnancy or myocardial infarction (MI) within the past 2 weeks)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization into one of 2 groups will be stratified by recruiter and a binary nicotine dependency code
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contingency Management (CM)<br>In addition to receiving usual cessation care at the Tom Waddell Urban Health Center (TWUHC), CM intervention participants with CO-verified abstinence will obtain a CM incentive payment, via gift cards and/or cash redeemable in national retail chains. | Behavioral: Contingency Management - Increasing<br>* Increasing incentive payment for abstinent participant<br>|
| Other: Control Group<br>Participants who choose to attend smoking cessation in the usual care setting at TWUHC will receive a basic $5 payment for attending each study visit. | Behavioral: Fixed payments<br>* Fixed payments for attending study visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who achieve point prevalence abstinence | The proportion of participants who achieve biochemically-verified 7-day point prevalence abstinence defined as participants (1) reporting not smoking a single cigarette in the past seven days, not even a puff; (2) having carbon monoxide (CO) levels <=5 parts per million (ppm), and (3) urinary anatabine/anabasine assay levels < 2 nanograms per milliliter (ng/ml). | 6 months | 
| Median number of carbon monoxide (CO) negative samples | The total number of negative CO specimen samples collected throughout the first 6 months of the program will be reported with 24 maximum possible number of samples per person. | 6 months | 
| Median total number of counseling sessions attended | The number of counseling sessions attended per person will will recorded with a maximum of 5 sessions total. | 6 months | 
| Proportion of the sample retained as a result of retention procedures over time | The proportion of participants who choose to attend cessation sessions visits at 2 weeks, 1 month, 3 months, 6 months, and 12 months. A participant will be considered lost to follow-up and censored on their last visits if the participants have failed to return for a scheduled visit and the study staff are unable to contact the participant after at least 3 attempts. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who achieve point prevalence abstinence | The proportion of participants who achieve biochemically-verified 7-day point prevalence abstinence defined as participants (1) reporting not smoking a single cigarette in the past seven days, not even a puff; (2) having carbon monoxide (CO) levels <=5 parts per million (ppm) | 3 months | 
| Proportion of participants who achieve point prevalence abstinence | The proportion of participants who achieve biochemically-verified 7-day point prevalence abstinence defined as participants (1) reporting not smoking a single cigarette in the past seven days, not even a puff; (2) having carbon monoxide (CO) levels <=5 parts per million (ppm) | 12 months | 
| Proportion of participants who achieve prolonged abstinence over time | Prolonged abstinence is defined as participants (1) not smoking a single cigarette since the last visit; (2) having CO levels <=5 ppm | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contingency Management