An interventional study of Contingency Management - Increasing and Fixed payments in Smoking Cessation, Smoking, Tobacco and Smoking Reduction, sponsored by University of California, San Francisco. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research
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:
University of California, San Francisco is the lead sponsor of 2,133 studies on the registry; 376 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Increasing incentive payment for abstinent participant
Fixed payments for attending study visits
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 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)
Time frame: 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)
Time frame: 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
Time frame: Up to 6 months
Plan to share: No
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco