Enhancing Smoking Cessation in the Homeless Population

November 17, 2020 updated by: University of Minnesota
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

352

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • NRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CO-verified Smoking Status at 26 Weeks
Time Frame: 7-day smoking abstinence at week 26 follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
CO-verified Smoking Status at 12 Weeks
Time Frame: at weeks 12
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Reported Continuous Alcohol Abstinence for 30 Days
Time Frame: at week 26
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Pratt Rebekah, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Actual)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1307M39761
  • 2R01HL081522-05A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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