Overview

This trial is active, not recruiting.

Condition cigarette smoking
Treatments contingency management, standard smoking cessation counseling, transdermal nicotine replacement [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)],, breath sample monitoring
Sponsor University of Connecticut Health Center
Collaborator National Institute on Drug Abuse (NIDA)
Start date October 2012
End date October 2016
Trial size 70 participants
Trial identifier NCT01736982, 12-186-2, R21DA031897

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
transdermal nicotine replacement [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)], breath sample monitoring, standard smoking cessation counseling.
standard smoking cessation counseling
transdermal nicotine replacement [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)],
breath sample monitoring
(Experimental)
Standard smoking cessation intervention plus contingency management
contingency management
Participants earn reinforcement in the form of prizes for breath samples that test negative for cigarette smoking.
standard smoking cessation counseling
transdermal nicotine replacement [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)],
breath sample monitoring

Primary Outcomes

Measure
Longest Duration of Abstinence
time frame: Week 4

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - age ≥ 18 years - homeless - regular smoker Exclusion Criteria: - non-English speaking - contra-indications for transdermal nicotine - in recovery for pathological gambling

Additional Information

Official title Contingency Management for Smoking Cessation in the Homeless
Principal investigator Carla J Rash, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Connecticut Health Center.