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Enhancing Smoking Cessation in the Homeless Population

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ClinicalTrials.gov Identifier: NCT01932996
Recruitment Status : Recruiting
First Posted : August 30, 2013
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Tobacco Smoking Smoking, Tobacco Drug: nicotine patch plus nicotine gum/lozenge Behavioral: Intensive Alcohol Intervention Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing Smoking Cessation in the Homeless Population
Study Start Date : January 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Integrated Intensive Smoking + Alcohol
IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.
Drug: nicotine patch plus nicotine gum/lozenge
12-week treatment with nicotine patch plus nicotine gum/lozenge
Other Name: NRT
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
Other Name: Cognitive Behavioral Therapy, CBT
Placebo Comparator: Usual Care
UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines
Drug: nicotine patch plus nicotine gum/lozenge
12-week treatment with nicotine patch plus nicotine gum/lozenge
Other Name: NRT



Primary Outcome Measures :
  1. cotinine-verified Smoking Status [ Time Frame: 7-day smoking abstinence at week 26 follow-up ]

Secondary Outcome Measures :
  1. cotinine verified prolonged smoking abstinence [ Time Frame: at weeks 12 and 26 ]

Other Outcome Measures:
  1. self-reported continuous alcohol abstinence for 90 days [ Time Frame: at week 26 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932996


Contacts
Contact: Rebekah Pratt, PhD 612-625-1196 rjpratt@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Cathy Strobel-Ayres, MA    612-624-7984    cstrobel@umn.edu   
Sub-Investigator: Anne M Joseph, MD         
Sub-Investigator: Janet L Thomas, PhD         
Sub-Investigator: Susan Everson-Rose, PhD         
Sub-Investigator: Ned Cooney, PhD         
Sub-Investigator: Sheila Specker, MD         
Principal Investigator: Rebekah J Pratt, PhD         
Sub-Investigator: Xianghua Luo, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Pratt Rebekah, PhD University of Minnesota - Clinical and Translational Science Institute

Publications of Results:
HUD. Homelessness: Programs and the people they serve. Washington, DC: US Housing and Urban Development ; 1999
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.
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
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. (1994).
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.
Cooney JL, Cooney NL, Patten Ca, George TP. Comorbidity of Nicotine Dependence with affective, psychotic and substance treatment disorders. New York: Marcel Dekker; 2004.
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 pub. No. 95-3931. Bethesda, MD: National Institute of Health, National institute on Alcohol Abuse and Alcoholism; 1995
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 Dependence; 2001.
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; No. NIH Publication NO. 03-3745.
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 counseling patients with alcohol abuse and dependence. Vol 3. DHHS publication no. (ADM) 92-1895 ed. Rockville, MD: US Government Printing Office; 1992.
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.

Other Publications:
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.
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.
Bernard R. Research Methods in Anthropology: Qualitative an Quantitative Approaches. Landham, MD: Altamira Press 2002.
Atlas ti. Atlas.ti version 4.0 for Windows [computer program]. Version. Berlin, Germany. 1997.
Winer BJ. Statistical principles in experimental design (2nd Ed.). New York: McGraw-Hill; 1971.
Little R, Rubin D. Statistical Analysis with Missing Data. 2nd ed. New York, NY: Wiley; 2002.
Rubin D. Multiple Imputation for Non-Response in Surveys. New York: John Wiley & Sons, 1987.
Rogers EM. Diffusion of Innovations. New York: Free Press; 2003.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01932996     History of Changes
Other Study ID Numbers: 1307M39761
2R01HL081522-05A1 ( U.S. NIH Grant/Contract )
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Smoking Cessation
Smoking Cessation Products
Tobacco Use Cessation Products

Additional relevant MeSH terms:
Ethanol
Nicotine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action