Contingency Management for Smoking Cessation in the Homeless

NCT ID: NCT01736982

Last Updated: 2018-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-07-31

Brief Summary

Smoking cessation services are an unmet need among the homeless, who smoke at rates more than 3 times the national estimate; successful interventions in this underserved population have the potential for improving individual and public health. Contingency management (CM) is a behavioral intervention with efficacy in a number of substance use disorder populations, including smokers. However, no known studies have evaluated the effect of CM in homeless smokers. The investigators plan to examine smoking-related outcomes in homeless treatment-seeking smokers (N = 70) randomized to standard care smoking cessation (transdermal nicotine replacement therapy [NRT] + standard counseling + carbon monoxide [CO] monitoring) or standard care plus CM (NRT + standard counseling + CO monitoring + CM) conditions. Standard counseling and CO monitoring will occur for the first 4 weeks, with NRT use continuing through week 8. Participants in both conditions will meet with study staff up to twice daily on weekdays for biochemical verification of smoking status. Participants in the CM condition will have the opportunity to earn prizes for negative breath samples (CO ≤ 4 ppm) up to twice daily on weekdays. CO breath samples will be collected at all visits. The investigators expect that participants randomized to CM will have better outcomes compared to those in standard care.

Conditions

Cigarette Smoking

Study Design

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

Study Groups

Standard of Care

transdermal nicotine replacement \[21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)\], breath sample monitoring, standard smoking cessation counseling

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Standard smoking cessation counseling

Standard of Care

Intervention Type: OTHER

transdermal nicotine replacement \[21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)\]

Standard of Care

Intervention Type: OTHER

Breath sample monitoring

Standard of Care plus Contingency Management

Standard smoking cessation intervention plus contingency management

Group Type: EXPERIMENTAL

Contingency Management

Intervention Type: BEHAVIORAL

Participants earn reinforcement in the form of prizes for breath samples that test negative for cigarette smoking.

Standard of Care

Intervention Type: OTHER

Standard smoking cessation counseling

Standard of Care

Intervention Type: OTHER

transdermal nicotine replacement \[21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)\]

Standard of Care

Intervention Type: OTHER

Breath sample monitoring

Interventions

Contingency Management

Participants earn reinforcement in the form of prizes for breath samples that test negative for cigarette smoking.

Intervention Type: BEHAVIORAL

Standard of Care

Standard smoking cessation counseling

Intervention Type: OTHER

Standard of Care

transdermal nicotine replacement \[21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)\]

Intervention Type: OTHER

Standard of Care

Breath sample monitoring

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age ≥ 18 years
• homeless
• regular smoker

Exclusion Criteria

• non-English speaking
• contra-indications for transdermal nicotine
• in recovery for pathological gambling

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carla J Rash, PhD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

The Friendship Center

New Britain, Connecticut, United States

Countries

United States

Other Identifiers

R21DA031897

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-186-2

Identifier Type: -

Identifier Source: org_study_id