Enhancing Smoking Cessation in the Homeless Population

NCT01932996 | Completed Phase 4 Results

• 2 other identifiers: 1307M397612R01HL081522-05A1
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking; Tobacco Smoking; Smoking, Tobacco

Keywords

Smoking Cessation; Smoking Cessation Products; Tobacco Use Cessation Products

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• CO-verified Smoking Status at 12 Weeks

  at weeks 12

Other Outcomes (1)

• Self-Reported Continuous Alcohol Abstinence for 30 Days

  at week 26

Study Arms (2)

Integrated Intensive Smoking + Alcohol

ACTIVE COMPARATOR

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; Behavioral: Intensive Alcohol Intervention

Usual Care

PLACEBO COMPARATOR

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

Interventions

nicotine patch plus nicotine gum/lozenge DRUG

12-week treatment with nicotine patch plus nicotine gum/lozenge

Also known as: NRT

Integrated Intensive Smoking + Alcohol; Usual Care

Intensive Alcohol Intervention BEHAVIORAL

Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months

Also known as: Cognitive Behavioral Therapy, CBT

Integrated Intensive Smoking + Alcohol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

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MeSH Terms

Conditions

Cigarette Smoking; Tobacco Smoking; Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Ethanol; Methods; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Alcohols; Organic Chemicals; Investigative Techniques; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Rebekah Pratt
• Organization: University of Minnesota

rjpratt@umn.edu

612-625-1196

Study Officials

• Pratt Rebekah, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: August 30, 2013
• Study Start: January 1, 2015
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: November 19, 2020
• Results First Posted: November 19, 2020

Record last verified: 2020-11

Locations

US (1)