Clinical trial NCT04982952: Contingency Management for Smoking Cessation
Official title: Randomized Trial of a Contingency Management Smoking Cessation Intervention for Homeless Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Smoking, Tobacco
Smoking Reduction
Keywords: Contingency Management
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
First posted: 2021-07-29
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization into one of 2 groups will be stratified by recruiter and a binary nicotine dependency code
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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:

1. Measuring biochemically-verified point prevalence abstinence at 6 months follow-up.
2. Measuring participant adherence to the protocol.
3. Gathering information on the number of visits attended.
4. Assessing the retention protocol.

Secondary Objectives

Assess feasibility and acceptability of a CM intervention through:

1. Biochemically-verified 7-day point months follow-up at 3 months.
2. Prolonged abstinence at 3 months and 6 months follow-up.
3. Point-prevalent abstinence at 12 months

Eligibility criteria: Inclusion Criteria:

1. Are 18 years or older
2. Engaged in care at the Tom Waddell Urban Health Center (TWUHC)
3. Meet criteria for homelessness as defined by the Homeless Emergency Assistance and Rapid Transition to Housing Act
4. 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))
5. Have an intention to quit smoking within the next six months
6. Are attending on-site smoking cessation counseling provided by the behavioral counselors
7. Are English proficient
8. 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)

Primary outcomes:
measure: Proportion of participants who achieve point prevalence abstinence
timeFrame: 6 months
measure: Median number of carbon monoxide (CO) negative samples
timeFrame: 6 months
measure: Median total number of counseling sessions attended
timeFrame: 6 months
measure: Proportion of the sample retained as a result of retention procedures over time
timeFrame: Up to 12 months
Secondary outcomes:
measure: Proportion of participants who achieve point prevalence abstinence
timeFrame: 3 months
measure: Proportion of participants who achieve point prevalence abstinence
timeFrame: 12 months
measure: Proportion of participants who achieve prolonged abstinence over time
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: The Richard H. Fine's People's Clinic
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Maya Vijayaraghavan, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: