Enhancing Smoking Cessation in the Homeless Population
Status:
Completed
Trial end date:
2018-10-31
Target enrollment:
Participant gender:
Summary
The goal of this research study is to enhance smoking cessation rates for homeless smokers.
The original study design proposed to test the effects of 1) an Intensive Smoking
Intervention, and 2) integrating alcohol abuse treatment with smoking cessation We will
utilize a 3-group randomized design to test study hypotheses. The three study conditions are
1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy
(CBT), CBT-(IS+A); 2) Intensive Smoking Intervention using CBT-(IS); or 3) Usual Care (brief
smoking cessation and brief alcohol counseling both based on the United States Public Health
Service's Guidelines)-(UC). Due to low enrollment because of the addition of an alcohol use
screening criteria, the study was changed to a two arm study and the study time frame
changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol
intervention using cognitive behavioral therapy (CBT), CBT-(IS+A) and 2) Usual Care (brief
smoking cessation and brief alcohol counseling both based on the United States Public Health
Service's Guidelines)-(UC). The study length is reduced to 26 weeks from 52 weeks. All
participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge.
Counseling will follows the protocol used in a recent study of alcohol dependent smokers and
will include weekly individual sessions for 3 months followed by study data collection visits
3 months. Both study conditions will have equal number of study contacts. Study staff will
make retention contacts with participants in the community during weeks that do not have
study visits scheduled. Primary smoking outcome is cotinine-verified 7-day smoking abstinence
at week 26 follow-up while secondary outcome is prolonged smoking abstinence at weeks 12, 16,
and 26. Secondary alcohol outcome will be self-reported continuous alcohol abstinence for 90
days at week 26. Recruitment and retention will be enhanced by use of gift cards, bus passes,
other non-monetary incentives, attractive intervention materials, collaboration with homeless
shelters, and advice from a Community Advisory Board. Participants will be enrolled from
homeless shelters and facilities in the 7-county greater Minneapolis/St. Paul metro area. Our
power calculation indicates that a sample size of 215 per study condition is needed to detect
proposed treatment effects.
Phase:
Phase 4
Details
Lead Sponsor:
University of Minnesota University of Minnesota - Clinical and Translational Science Institute