Contingency Management for Smoking Cessation

NCT ID: NCT04982952

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-09
• Study Completion Date: 2024-06-30

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

Conditions

Smoking Cessation; Smoking, Tobacco; Smoking Reduction

Keywords

Contingency Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Contingency Management (CM)

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.

Group Type: EXPERIMENTAL

Contingency Management - Increasing

Intervention Type: BEHAVIORAL

Increasing incentive payment for abstinent participant

Control Group

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.

Group Type: OTHER

Fixed payments

Intervention Type: BEHAVIORAL

Fixed payments for attending study visits

Interventions

Contingency Management - Increasing

Increasing incentive payment for abstinent participant

Intervention Type: BEHAVIORAL

Fixed payments

Fixed payments for attending study visits

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tobacco Related Disease Research Program

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maya Vijayaraghavan, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

The Richard H. Fine's People's Clinic

San Francisco, California, United States

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36525405 (View on PubMed)

Other Identifiers

NCI-2021-08359

Identifier Type: REGISTRY

Identifier Source: secondary_id

21632

Identifier Type: -

Identifier Source: org_study_id