title: Integrating smoking cessation and alcohol use treatment in homeless populations: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Despite progress in reducing cigarette smoking in the general U.S. population, smoking rates, cancer morbidity and related heart disease remain strikingly high among the poor and underserved. Homeless individuals' cigarette smoking rate remains an alarming 70% or greater, and this population is generally untreated with smoking cessation interventions. Furthermore, the majority of homeless smokers also abuse alcohol and other drugs, which makes quitting more difficult and magnifies the health consequences of tobacco use.
  
  
  METHODS
  Participants will be randomized to one of three groups, including (1) an integrated intensive smoking plus alcohol intervention using cognitive behavioral therapy (CBT), (2) intensive smoking intervention using CBT or (3) usual care (i.e., brief smoking cessation and brief alcohol counseling). All participants will receive 12-week treatment with a nicotine patch plus nicotine gum or lozenge. Counseling will include weekly individual sessions for 3 months, followed by monthly booster group sessions for 3 months. The primary smoking outcome is cotinine-verified 7-day smoking abstinence at follow-up week 52, and the primary alcohol outcome will be breathalyzer-verified 90-day alcohol abstinence at week 52.
  
  
  CONCLUSIONS
  This study protocol describes the design of the first community-based controlled trial (n = 645) designed to examine the efficacy of integrating alcohol abuse treatment with smoking cessation among homeless smokers. To further address the gap in effectiveness of evidence-based smoking cessation interventions in the homeless population, we are conducting a renewed smoking cessation clinical trial called Power to Quit among smokers experiencing homelessness.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01932996. Date of registration: 20 November 2014.
authors: Department of Family Medicine and Community Health, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. oojofati@umn.edu.|Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. oojofati@umn.edu.
authors: Olamide
authors: O
authors: Ojo-Fati
authors: Department of Family Medicine and Community Health, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. joh09053@umn.edu.|Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. joh09053@umn.edu.
authors: Florence
authors: F
authors: John
authors: Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. jthomas@umn.edu.|Department of Medicine, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. jthomas@umn.edu.
authors: Janet
authors: J
authors: Thomas
authors: Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. amjoseph@umn.edu.|Department of Medicine, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. amjoseph@umn.edu.
authors: Anne M
authors: AM
authors: Joseph
authors: Department of Family Medicine and Community Health, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. raymo002@umn.edu.|Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. raymo002@umn.edu.|Department of Psychiatry, University of Minnesota Medical School, Medical School, Academic Affairs, 420 Delaware Street SE, Minneapolis, MN, 55455, USA. raymo002@umn.edu.
authors: Nancy C
authors: NC
authors: Raymond
authors: Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 901, New Haven, CT, 06511, USA. ned.cooney@yale.edu.
authors: Ned L
authors: NL
authors: Cooney
authors: Department of Family Medicine and Community Health, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. rjpratt@umn.edu.|Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. rjpratt@umn.edu.
authors: Rebekah
authors: R
authors: Pratt
authors: Department of Family Medicine and Community Health, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. crrogers@umn.edu.|Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. crrogers@umn.edu.
authors: Charles R
authors: CR
authors: Rogers
authors: Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. saer@umn.edu.|Department of Medicine, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. saer@umn.edu.
authors: Susan A
authors: SA
authors: Everson-Rose
authors: Division of Biostatistics, School of Public Health, University of Minnesota, A460 Mayo Building, MMC 303, 420 Delaware Street SE, Minneapolis, MN, 55455, USA. luox0054@umn.edu.
authors: Xianghua
authors: X
authors: Luo
authors: Department of Family Medicine and Community Health, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. kokuyemi@umn.edu.|Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware Street SE, Suite 166, Minneapolis, MN, 55414, USA. kokuyemi@umn.edu.
authors: Kolawole S
authors: KS
authors: Okuyemi
mesh_terms: D064829:Alcohol Abstinence; D000437:Alcoholism / Q000150:complications / Q000175:diagnosis / Q000517:prevention & control* / Q000523:psychology; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003153:Community Health Services; D006703:Ill-Housed Persons / Q000523:psychology; D006801:Humans; D008910:Minnesota; D012008:Recurrence; D012107:Research Design; D012907:Smoking / Q000009:adverse effects / Q000523:psychology; D016540:Smoking Cessation; D000074606:Smoking Prevention; D013997:Time Factors; D016896:Treatment Outcome