Contingency Management for Smoking Cessation

NCT04982952 | Completed

• 2 other identifiers: 21632NCI-2021-08359
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking Cessation; Smoking, Tobacco; Smoking Reduction

Keywords

Contingency Management

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Proportion of participants who achieve point prevalence abstinence

  3 months

• Proportion of participants who achieve point prevalence abstinence

  12 months

• Proportion of participants who achieve prolonged abstinence over time

  Up to 6 months

Study Arms (2)

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.

Behavioral: Contingency Management - Increasing

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.

Behavioral: Fixed payments

Interventions

Contingency Management - Increasing BEHAVIORAL

Increasing incentive payment for abstinent participant

Contingency Management (CM)

Fixed payments BEHAVIORAL

Fixed payments for attending study visits

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Are unable to take nicotine replacement therapy (e.g., pregnancy or myocardial infarction (MI) within the past 2 weeks)

Sponsors & Collaborators

• University of California, San Francisco: lead
• Tobacco Related Disease Research Program: collaborator

Study Sites (2)

The Richard H. Fine's People's Clinic

San Francisco, California, 94110, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 36525405 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Tobacco Smoking; Smoking Reduction

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Tobacco Use

Study Officials

• Maya Vijayaraghavan, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization into one of 2 groups will be stratified by recruiter and a binary nicotine dependency code

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: July 29, 2021
• Study Start: November 9, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)