Enhancing Smoking Cessation in the Homeless Population
Condition: Cigarette Smoking; Tobacco Smoking; Smoking, Tobacco
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      To achieve the study goal, we have selected a 3-group randomized clinical trial (RCT) design
      that includes 1) Usual Care, 2) Intensive smoking cessation, and 3) Integrated Intensive
      Smoking and Alcohol Intervention. 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. Having
      alcohol treatment added to the smoking intervention will enable us assess whether addressing
      alcohol abuse will result in improved smoking abstinence, an important scientific question
      that has never been studied in homeless populations.

      Study conditions: Both study conditions have identical number of contacts; we considered a
      design in which the duration of counseling in the UC will be identical to those in the IS+A
      condition but decided against this because it will create a usual care condition that exceeds
      standard practice for brief interventions. We understand that testing hypothesis 3 confounds
      contact time with treatment content, and hence we will not be able to determine that observed
      differences in outcome are due to specific treatment components. However, given the current
      state of knowledge about treating homeless alcohol abusing smokers, we believe it is
      sufficient to show that our intervention led to improved outcome in this group without
      knowing if the finding is due to specific intervention content. Subsequent research will be
      needed to disentangle various intervention components.

      All participants will receive 12-week treatment with nicotine patch plus nicotine
      gum/lozenge. Counseling will include weekly individual sessions for 3 months followed by
      study data collection visits for 3 months. Each participant will be randomly assigned to a
      condition, which will dictate their treatment. Each participant will be asked to engage in
      the therapy assigned to their condition, and work to quit smoking and consuming alcohol over
      a period of one year.
    

Intervention name(s): nicotine patch plus nicotine gum/lozenge; Intensive Alcohol Intervention
Intervention type(s): Drug; Behavioral
Intervention description(s): 12-week treatment with nicotine patch plus nicotine gum/lozenge; Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
Other intervention name(s): NRT; Cognitive Behavioral Therapy, CBT
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation; Smoking Cessation Products; Tobacco Use Cessation Products