Enhancing Smoking Cessation in the Homeless Population
Condition: Cigarette Smoking; Tobacco Smoking; Smoking, Tobacco
Intervention: nicotine patch plus nicotine gum/lozenge; Intensive Alcohol Intervention
Intervention description: 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
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 352.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking Cessation; Smoking Cessation Products; Tobacco Use Cessation Products

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently Homeless

          -  Smoked at least 100 cigarettes in lifetime

          -  AUDIT score of > or equal to 5, < or equal to 26

          -  Aged 18 years or older

          -  Willing to attend study sessions and follow other study protocol

        Exclusion Criteria:

          -  Use of smoking cessation medications or interventions in last 30 days

          -  Unstable medical illness that requires immediate medical care

          -  AUDIT score of < 5 or > 26

          -  Pregnancy or other Nicotine Replacement Therapy (NRT) contraindications

          -  Current history or in past 6 months of psychotic disorder or major depressive
             disorders that is not stable on treatment for past 3 months

          -  Cognitive impairment