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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-08359 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Tobacco Related Disease Research Program | OTHER |
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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.
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:
Secondary Objectives
Assess feasibility and acceptability of a CM intervention through:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contingency Management (CM) | Experimental | 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. |
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| Control Group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contingency Management - Increasing | Behavioral | Increasing incentive payment for abstinent participant |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. Are unable to take nicotine replacement therapy (e.g., pregnancy or myocardial infarction (MI) within the past 2 weeks)
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| Name | Affiliation | Role |
|---|---|---|
| Maya Vijayaraghavan, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Richard H. Fine's People's Clinic | San Francisco | California | 94110 | United States | ||
| University of California, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36525405 | Derived | Molina MF, Hall SM, Stitzer M, Kushel M, Chakravarty D, Vijayaraghavan M. Contingency management to promote smoking cessation in people experiencing homelessness: Leveraging the electronic health record in a pilot, pragmatic randomized controlled trial. PLoS One. 2022 Dec 16;17(12):e0278870. doi: 10.1371/journal.pone.0278870. eCollection 2022. |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000073869 | Tobacco Smoking |
| D000074264 | Smoking Reduction |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
| D064424 | Tobacco Use |
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Randomization into one of 2 groups will be stratified by recruiter and a binary nicotine dependency code
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| Fixed payments | Behavioral | Fixed payments for attending study visits |
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| 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 |
| San Francisco |
| California |
| 94143 |
| United States |