Enhancing Smoking Cessation in the Homeless Population

Cigarette Smoking Clinical Trial

Official title:

Enhancing Smoking Cessation in the Homeless Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932996
• Other study ID #: 1307M39761
• Secondary ID: 2R01HL081522-05A
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: October 31, 2018

Study information

• Verified date: November 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking
• Smoking, Tobacco
• Tobacco Smoking

Intervention

Drug:
• nicotine patch plus nicotine gum/lozenge
12-week treatment with nicotine patch plus nicotine gum/lozenge

Behavioral:
• Intensive Alcohol Intervention
Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (106)

Allen JO, Wilson VB, eds. Assessing Alcohol Problems: a Guide for Clinicians and Researchers. Second Ed. Bethesda. Maryland, USA: U.S. Department of Health and Human Services. Public Health Service. National Institute on Alcohol Abuse and Alcoholism; 2003

Amodei N, Lamb RJ. Convergent and concurrent validity of the Contemplation Ladder and URICA scales. Drug Alcohol Depend. 2004 Mar 8;73(3):301-6. — View Citation

Anthony, JC., Warner, L A., & Kessler, RC.Comparative epidemiology of dependence on tobacco, alcohol, controlled substances, and inhalants: Basic findings from the National Comorbidity Survey. Experimental and Clinical Psychopharmacology, 2(3), 244-268. (

Atlas ti. Atlas.ti version 4.0 for Windows [computer program]. Version. Berlin, Germany. 1997.

Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro MG. AUDIT: The alcohol Use Disorders Identification Test-Guidelines for Use in Primary Care. Second Edition. Geneva Switzerland: world Health Organization, Department of Mental Health and Substance Abuse

Babor TF, Higgins-Biddle JC. Alcohol screening and brief intervention: dissemination strategies for medical practice and public health. Addiction. 2000 May;95(5):677-86. Review. — View Citation

Baca CT, Yahne CE. Smoking cessation during substance abuse treatment: what you need to know. J Subst Abuse Treat. 2009 Mar;36(2):205-19. doi: 10.1016/j.jsat.2008.06.003. Epub 2008 Aug 20. Review. — View Citation

Barnes LL, Mendes de Leon CF, Bienias JL, Evans DA. A longitudinal study of black-white differences in social resources. J Gerontol B Psychol Sci Soc Sci. 2004 May;59(3):S146-53. — View Citation

Barrow SM, Herman DB, Córdova P, Struening EL. Mortality among homeless shelter residents in New York City. Am J Public Health. 1999 Apr;89(4):529-34. — View Citation

Bech P, Larsen JK, Andersen J. The BPRS: psychometric developments. Psychopharmacol Bull. 1988;24(1):118-21. — View Citation

Bernard R. Research Methods in Anthropology: Qualitative an Quantitative Approaches. Landham, MD: Altamira Press 2002.

Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10(5):360-5. — View Citation

Bobo JK, McIlvain HE, Lando HA, Walker RD, Leed-Kelly A. Effect of smoking cessation counseling on recovery from alcoholism: findings from a randomized community intervention trial. Addiction. 1998 Jun;93(6):877-87. — View Citation

Brownson RC, Jones E. Bridging the gap: translating research into policy and practice. Prev Med. 2009 Oct;49(4):313-5. doi: 10.1016/j.ypmed.2009.06.008. Epub 2009 Jun 22. Review. — View Citation

Burling TA, Marshall GD, Seidner AL. Smoking cessation for substance abuse inpatients. J Subst Abuse. 1991;3(3):269-76. — View Citation

Burling TA, Ziff DC. Tobacco smoking: a comparison between alcohol and drug abuse inpatients. Addict Behav. 1988;13(2):185-90. — View Citation

Butler J, Okuyemi KS, Jean S, Nazir N, Ahluwalia JS, Resnicow K. Smoking characteristics of a homeless population. Subst Abus. 2002 Dec;23(4):223-31. — View Citation

Castellsagué X, Muñoz N, De Stefani E, Victora CG, Castelletto R, Rolón PA, Quintana MJ. Independent and joint effects of tobacco smoking and alcohol drinking on the risk of esophageal cancer in men and women. Int J Cancer. 1999 Aug 27;82(5):657-64. — View Citation

Chau S, Chin M, Chang J, Luecha A, Cheng E, Schlesinger J, Rao V, Huang D, Maxwell AE, Usatine R, Bastani R, Gelberg L. Cancer risk behaviors and screening rates among homeless adults in Los Angeles County. Cancer Epidemiol Biomarkers Prev. 2002 May;11(5) — View Citation

Chiolero A, Wietlisbach V, Ruffieux C, Paccaud F, Cornuz J. Clustering of risk behaviors with cigarette consumption: A population-based survey. Prev Med. 2006 May;42(5):348-53. Epub 2006 Feb 28. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

Cohen S, Lichtenstein E. Partner behaviors that support quitting smoking. J Consult Clin Psychol. 1990 Jun;58(3):304-9. — View Citation

Cohen S, Mermelstein R, Kamarck T, Hoberman H, eds. Mesuring the functional components of social support. In Sarason IG, Sarason BR, eds. Social Support: Theory, Research, and Application. The Hague, the Netherlands: Martunus Nijhoff; 1985.

Connor SE, Cook RL, Herbert MI, Neal SM, Williams JT. Smoking cessation in a homeless population: there is a will, but is there a way? J Gen Intern Med. 2002 May;17(5):369-72. — View Citation

Cooney JL, Cooney NL, Patten Ca, George TP. Comorbidity of Nicotine Dependence with affective, psychotic and substance treatment disorders. New York: Marcel Dekker; 2004.

Cooney JL, Cooney NL, Pilkey DT, Kranzler HR, Oncken CA. Effects of nicotine deprivation on urges to drink and smoke in alcoholic smokers. Addiction. 2003 Jul;98(7):913-21. — View Citation

Cooney NL, Cooney JL, Perry BL, Carbone M, Cohen EH, Steinberg HR, Pilkey DT, Sevarino K, Oncken CA, Litt MD. Smoking cessation during alcohol treatment: a randomized trial of combination nicotine patch plus nicotine gum. Addiction. 2009 Sep;104(9):1588-9 — View Citation

Cooney NL, Litt MD, Cooney JL, Pilkey DT, Steinberg HR, Oncken CA. Alcohol and tobacco cessation in alcohol-dependent smokers: analysis of real-time reports. Psychol Addict Behav. 2007 Sep;21(3):277-86. — View Citation

Cooney NL, Litt MD, Cooney JL, Pilkey DT, Steinberg HR, Oncken CA. Concurrent brief versus intensive smoking intervention during alcohol dependence treatment. Psychol Addict Behav. 2007 Dec;21(4):570-5. — View Citation

Cornoni-Huntley J, Brock D, Ostfeld A, Taylor J, Wallace R. Established populations for for epidemiologic studies of the elderly: Resource data book. Washington, DCL US Department of Health and Human Services; 1986.

Cousineau MR. Health status of and access to health services by residents of urban encampments in Los Angeles. J Health Care Poor Underserved. 1997 Feb;8(1):70-82. — View Citation

Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001 Feb;3(1):7-16. — View Citation

Cummings SR, Richard RJ. Optimum cutoff points for biochemical validation of smoking status. Am J Public Health. 1988 May;78(5):574-5. — View Citation

Dawson DA. Drinking as a risk factor for sustained smoking. Drug Alcohol Depend. 2000 Jun 1;59(3):235-49. — View Citation

DiClemente CC, Carbonari JP, Montgomery RP, Hughes SO. The Alcohol Abstinence Self-Efficacy scale. J Stud Alcohol. 1994 Mar;55(2):141-8. — View Citation

Etter JF, Bergman MM, Humair JP, Perneger TV. Development and validation of a scale measuring self-efficacy of current and former smokers. Addiction. 2000 Jun;95(6):901-13. — View Citation

Fagerström KO. Measuring degree of physical dependence to tobacco smoking with reference to individualization of treatment. Addict Behav. 1978;3(3-4):235-41. — View Citation

Falk DE, Yi HY, Hiller-Sturmhöfel S. An epidemiologic analysis of co-occurring alcohol and tobacco use and disorders: findings from the National Epidemiologic Survey on Alcohol and Related Conditions. Alcohol Res Health. 2006;29(3):162-71. — View Citation

Ferenchick GS. The medical problems of homeless clinic patients: a comparative study. J Gen Intern Med. 1992 May-Jun;7(3):294-7. — View Citation

Fischer PJ, Breakey WR. The epidemiology of alcohol, drug, and mental disorders among homeless persons. Am Psychol. 1991 Nov;46(11):1115-28. Review. — View Citation

Flannery BA, Roberts AJ, Cooney N, Swift RM, Anton RF, Rohsenow DJ. The role of craving in alcohol use, dependence, and treatment. Alcohol Clin Exp Res. 2001 Feb;25(2):299-308. Review. — View Citation

Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. — View Citation

Friedemann-Sánchez G, Griffin JM, Partin MR. Gender differences in colorectal cancer screening barriers and information needs. Health Expect. 2007 Jun;10(2):148-60. — View Citation

Gariti P, Alterman A, Mulvaney F, Mechanic K, Dhopesh V, Yu E, Chychula N, Sacks D. Nicotine intervention during detoxification and treatment for other substance use. Am J Drug Alcohol Abuse. 2002 Nov;28(4):671-9. — View Citation

Gelberg L, Linn LS. Demographic differences in health status of homeless adults. J Gen Intern Med. 1992 Nov-Dec;7(6):601-8. — View Citation

Glassman AH. Cigarette smoking: implications for psychiatric illness. Am J Psychiatry. 1993 Apr;150(4):546-53. Review. — View Citation

Goldade K, Choi K, Bernat DH, Klein EG, Okuyemi KS, Forster J. Multilevel predictors of smoking initiation among adolescents: findings from the Minnesota Adolescent Community Cohort (MACC) study. Prev Med. 2012 Mar-Apr;54(3-4):242-6. doi: 10.1016/j.ypmed. — View Citation

Goldade K, Whembolua GL, Thomas J, Eischen S, Guo H, Connett J, Des Jarlais D, Resnicow K, Gelberg L, Owen G, Grant J, Ahluwalia JS, Okuyemi KS. Designing a smoking cessation intervention for the unique needs of homeless persons: a community-based randomi — View Citation

Guitérrez-Bedmar M, Seguí-Gómez M, Gómez-Gracia E, Bes-Rastrollo M, Martínez-González MA. Smoking status, changes in smoking status and health-related quality of life: findings from the SUN ("Seguimiento Universidad de Navarra") cohort. Int J Environ Res — View Citation

Hajek P, West R, Foulds J, Nilsson F, Burrows S, Meadow A. Randomized comparative trial of nicotine polacrilex, a transdermal patch, nasal spray, and an inhaler. Arch Intern Med. 1999 Sep 27;159(17):2033-8. — View Citation

Hibbs JR, Benner L, Klugman L, Spencer R, Macchia I, Mellinger A, Fife DK. Mortality in a cohort of homeless adults in Philadelphia. N Engl J Med. 1994 Aug 4;331(5):304-9. — View Citation

HUD. Homelessness: Programs and the people they serve. Washington, DC: US Housing and Urban Development ; 1999

Hughes JR, Hatsukami D. Signs and symptoms of tobacco withdrawal. Arch Gen Psychiatry. 1986 Mar;43(3):289-94. — View Citation

Hughes JR. Clinical implications of the association between smoking and alcoholism, in Alcohol and Tobacco: From basic science to policy: NIAAA Research Monograph 30. Washington, DC; US Government Printing Press; 1995

Hurt RD, Eberman KM, Croghan IT, Offord KP, Davis LJ Jr, Morse RM, Palmen MA, Bruce BK. Nicotine dependence treatment during inpatient treatment for other addictions: a prospective intervention trial. Alcohol Clin Exp Res. 1994 Aug;18(4):867-72. — View Citation

Hurt RD, Offord KP, Croghan IT, Gomez-Dahl L, Kottke TE, Morse RM, Melton LJ 3rd. Mortality following inpatient addictions treatment. Role of tobacco use in a community-based cohort. JAMA. 1996 Apr 10;275(14):1097-103. Erratum in: JAMA 1996 Sep 11;276(10) — View Citation

Hwang SW, Lebow JM, Bierer MF, O'Connell JJ, Orav EJ, Brennan TA. Risk factors for death in homeless adults in Boston. Arch Intern Med. 1998 Jul 13;158(13):1454-60. — View Citation

Hwang SW. Mortality among men using homeless shelters in Toronto, Ontario. JAMA. 2000 Apr 26;283(16):2152-7. — View Citation

Istvan J, Matarazzo JD. Tobacco, alcohol, and caffeine use: a review of their interrelationships. Psychol Bull. 1984 Mar;95(2):301-26. — View Citation

Jolicoeur DG, Ahluwalia JS, Richter KP, Mosier M, Harris KJ, Gibson C, Moranetz CA. The use of nicotine patches with minimal intervention. Prev Med. 2000 Jun;30(6):504-12. — View Citation

Joseph A, Lexau B, Willenbring M, Nugent S, Nelson D. Factors associated with readiness to stop smoking among patients in treatment for alcohol use disorder. Am J Addict. 2004 Jul-Sep;13(4):405-17. — View Citation

Kadden R, Carroll K, Donovan D, Cooney N, Monti P, Abrams D. et al. Cognitive-Behavioral coping skills therapy Manual: Clinical research Guide for therapist cognitive- behavioral coping skills Therapy Manual: a clinical research guide for therapists couns

Kahler CW, Borland R, Hyland A, McKee SA, Thompson ME, Cummings KM. Alcohol consumption and quitting smoking in the International Tobacco Control (ITC) Four Country Survey. Drug Alcohol Depend. 2009 Mar 1;100(3):214-20. doi: 10.1016/j.drugalcdep.2008.10.0 — View Citation

Kalman D, Hayes K, Colby SM, Eaton CA, Rohsenow DJ, Monti PM. Concurrent versus delayed smoking cessation treatment for persons in early alcohol recovery. A pilot study. J Subst Abuse Treat. 2001 Apr;20(3):233-8. — View Citation

Kalman D. Smoking cessation treatment for substance misusers in early recovery: a review of the literature and recommendations for practice. Subst Use Misuse. 1998 Aug;33(10):2021-47. Review. — View Citation

Katzman R, Brown T, Fuld P, Peck A, Schechter R, Schimmel H. Validation of a short Orientation-Memory-Concentration Test of cognitive impairment. Am J Psychiatry. 1983 Jun;140(6):734-9. — View Citation

Kerker BD, Bainbridge J, Kennedy J, Bennani Y, Agerton T, Marder D, Forgione L, Faciano A, Thorpe LE. A population-based assessment of the health of homeless families in New York City, 2001-2003. Am J Public Health. 2011 Mar;101(3):546-53. doi: 10.2105/AJ — View Citation

Kozlowski LT, Skinner W, Kent C, Pope MA. Prospects for smoking treatment in individuals seeking treatment for alcohol and other drug problems. Addict Behav. 1989;14(3):273-8. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. — View Citation

Kushel MB, Vittinghoff E, Haas JS. Factors associated with the health care utilization of homeless persons. JAMA. 2001 Jan 10;285(2):200-6. — View Citation

Little R, Rubin D. Statistical Analysis with Missing Data. 2nd ed. New York, NY: Wiley; 2002.

McDonell MG, Howell DN, McPherson S, Cameron JM, Srebnik D, Roll JM, Ries RK. Voucher-based reinforcement for alcohol abstinence using the ethyl-glucuronide alcohol biomarker. J Appl Behav Anal. 2012 Spring;45(1):161-5. doi: 10.1901/jaba.2012.45-161. — View Citation

McKee SA, Falba T, O'Malley SS, Sindelar J, O'Connor PG. Smoking status as a clinical indicator for alcohol misuse in US adults. Arch Intern Med. 2007 Apr 9;167(7):716-21. — View Citation

Miller WR, Del Boca FK. Measurement of drinking behavior using the Form 90 family of instruments. J Stud Alcohol Suppl. 1994 Dec;12:112-8. Review. — View Citation

Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. Review. Erratum in: JAMA. 2005 Jan 19;293(3):298. Erratum in: JAMA. 2005 Jan 19;293(3):293-4. — View Citation

Monti PM, Rohsenow DJ, Colby Sm, Abrams DB. Smoking among alcoholics during and after treatment: implications for models, treatment strategies, and policy.In Fertig JB, Allen JP, eds. alcohol and tobacco: from basic science to clinical practice. Vol NIH p

Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. — View Citation

Muraven M, Baumeister RF. Self-regulation and depletion of limited resources: does self-control resemble a muscle? Psychol Bull. 2000 Mar;126(2):247-59. Review. — View Citation

Murray RP, Connett JE, Lauger GG, Voelker HT. Error in smoking measures: effects of intervention on relations of cotinine and carbon monoxide to self-reported smoking. The Lung Health Study Research Group. Am J Public Health. 1993 Sep;83(9):1251-7. — View Citation

Okuyemi KS, Thomas JL, Hall S, Nollen NL, Richter KP, Jeffries SK, Caldwell AR, Ahluwalia JS. Smoking cessation in homeless populations: a pilot clinical trial. Nicotine Tob Res. 2006 Oct;8(5):689-99. — View Citation

Orleans CT, Resch N, Noll E, Keintz MK, Rimer BK, Brown TV, Snedden TM. Use of transdermal nicotine in a state-level prescription plan for the elderly. A first look at 'real-world' patch users. JAMA. 1994 Feb 23;271(8):601-7. — View Citation

Palfai TP, Monti PM, Ostafin B, Hutchison K. Effects of nicotine deprivation on alcohol-related information processing and drinking behavior. J Abnorm Psychol. 2000 Feb;109(1):96-105. — View Citation

Pelucchi C, Gallus S, Garavello W, Bosetti C, La Vecchia C. Cancer risk associated with alcohol and tobacco use: focus on upper aero-digestive tract and liver. Alcohol Res Health. 2006;29(3):193-8. Review. — View Citation

Raskin A. Discussion: recent developments in ascertainment and scaling of the BPRS. Psychopharmacol Bull. 1988;24(1):122-4. — View Citation

Rogers EM. Diffusion of Innovations. New York: Free Press; 2003.

Roncone R, Ventura J, Impallomeni M, Falloon IR, Morosini PL, Chiaravalle E, Casacchia M. Reliability of an Italian standardized and expanded Brief Psychiatric Rating Scale (BPRS 4.0) in raters with high vs. low clinical experience. Acta Psychiatr Scand. — View Citation

Roski J, Schmid LA, Lando HA. Long-term associations of helpful and harmful spousal behaviors with smoking cessation. Addict Behav. 1996 Mar-Apr;21(2):173-85. — View Citation

Rost K, Burnam MA, Smith GR. Development of screeners for depressive disorders and substance disorder history. Med Care. 1993 Mar;31(3):189-200. — View Citation

Rubin D. Multiple Imputation for Non-Response in Surveys. New York: John Wiley & Sons, 1987.

Ruggeri M, Koeter M, Schene A, Bonetto C, Vàzquez-Barquero JL, Becker T, Knapp M, Knudsen HC, Tansella M, Thornicroft G; EPSILON Study Group. Factor solution of the BPRS-expanded version in schizophrenic outpatients living in five European countries. Schi — View Citation

Sachs-Ericsson N, Wise E, Debrody CP, Paniucki HB. Health problems and service utilization in the homeless. J Health Care Poor Underserved. 1999 Nov;10(4):443-52. — View Citation

Salit SA, Kuhn EM, Hartz AJ, Vu JM, Mosso AL. Hospitalization costs associated with homelessness in New York City. N Engl J Med. 1998 Jun 11;338(24):1734-40. — View Citation

Sarna L, Bialous SA, Cooley ME, Jun HJ, Feskanich D. Impact of smoking and smoking cessation on health-related quality of life in women in the Nurses' Health Study. Qual Life Res. 2008 Dec;17(10):1217-27. doi: 10.1007/s11136-008-9404-8. Epub 2008 Oct 18. — View Citation

Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791- — View Citation

Schmidt W, Popham RE. The role of drinking and smoking in mortality from cancer and other causes in male alcoholics. Cancer. 1981 Mar 1;47(5):1031-41. — View Citation

Schneider NG. Nicotine therapy in smoking cessation. Pharmacokinetic considerations. Clin Pharmacokinet. 1992 Sep;23(3):169-72. Review. — View Citation

Sees KL, Clark HW. When to begin smoking cessation in substance abusers. J Subst Abuse Treat. 1993 Mar-Apr;10(2):189-95. Review. — View Citation

Shelley D, Cantrell J, Wong S, Warn D. Smoking cessation among sheltered homeless: a pilot. Am J Health Behav. 2010 Sep-Oct;34(5):544-52. — View Citation

Shiffman S, West R, Gilbert D; SRNT Work Group on the Assessment of Craving and Withdrawal in Clinical Trials. Recommendation for the assessment of tobacco craving and withdrawal in smoking cessation trials. Nicotine Tob Res. 2004 Aug;6(4):599-614. Review — View Citation

Sobell L, Sobell M. Timeline follow-back: a technique for assessing self-reporting alcohol consumption In:. Timeline following-back: a technique for assessing self-reported alcohol consumption in:. Totowa, NJ: Humana Press; 1992.

SRNT Subcommittee on Biochemical Verification. Biochemical verification of tobacco use and cessation. Nicotine Tob Res. 2002 May;4(2):149-59. — View Citation

Torchalla I, Strehlau V, Okoli CT, Li K, Schuetz C, Krausz M. Smoking and predictors of nicotine dependence in a homeless population. Nicotine Tob Res. 2011 Oct;13(10):934-42. doi: 10.1093/ntr/ntr101. Epub 2011 May 26. — View Citation

United States Department of health and Human Services, ed Treating Tobacco Use and Dependence. Washington, DC: U.S. Dept. of Health and Human Services, Public Health Service; 2008.

Wilder Foundation. Homeless Adults and Children in Minnesota Statewide Survey. 2004; http;//www.wilder.org/fileadmin/user upload/research/ Homeless2003/adult/StatewideAdultsByMetroGreaterMN Tables 192-199.pdf. Accessed September 29, 2006, 2006.

Williams MV, Parker RM, Baker DW, Parikh NS, Pitkin K, Coates WC, Nurss JR. Inadequate functional health literacy among patients at two public hospitals. JAMA. 1995 Dec 6;274(21):1677-82. — View Citation

Winer BJ. Statistical principles in experimental design (2nd Ed.). New York: McGraw-Hill; 1971.

* Note: There are 106 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Reported Continuous Alcohol Abstinence for 30 Days	Participants will use a self-administered timeline-followback instrument, which asks them to retrospectively estimate their alcohol use in the 30 days prior to the report date. Outcome is reported as the mean number of continuous alcohol-free days over the past 30 day period.	at week 26
Primary	CO-verified Smoking Status at 26 Weeks	Smoking status is verified by measuring the concentration of carbon monoxide (CO) in expired air. Participants with a breath CO content less than or equal to 8 parts per million are characterized as abstinent from smoking for at least 7 days.	7-day smoking abstinence at week 26 follow-up
Secondary	CO-verified Smoking Status at 12 Weeks	Smoking status is verified by measuring the concentration of carbon monoxide (CO) in expired air. Participants with a breath CO content less than or equal to 8 parts per million are characterized as abstinent from smoking for at least 7 days.	at weeks 12