Enhancing Smoking Cessation in the Homeless Population

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01932996
First received: August 27, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  Purpose

The goal of this research study is to enhance smoking cessation rates for homeless smokers by testing 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). All participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge. Counseling will follow the protocol used in a recent study of alcohol dependent smokers and will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months. As a strategy to integrate proposed project with existing programs at the shelters, all group counseling sessions will be co-facilitated by trained study staff and trained homeless shelter staff. All 3 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 52 follow-up while secondary outcome is prolonged smoking abstinence at weeks 12, 24, and 52. Secondary alcohol outcome will be self-reported continuous alcohol abstinence for 90 days at week 52. Recruitment and retention will be enhanced by use of debit 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 Intervention Phase
Cigarette Smoking
Tobacco Smoking
Smoking, Tobacco
Drug: nicotine patch plus nicotine gum/lozenge
Behavioral: Intensive Smoking Intervention
Behavioral: Intensive Alcohol Intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enhancing Smoking Cessation in the Homeless Population

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • cotinine-verified Smoking Status [ Time Frame: 7-day smoking abstinence at week 52 follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cotinine verified prolonged smoking abstinence [ Time Frame: at weeks 12, 26, and 52 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • self-reported continuous alcohol abstinence for 90 days [ Time Frame: at week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 654
Study Start Date: January 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 monthly booster group sessions 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 Smoking Intervention
Weekly individual CBT smoking cessation sessions for 3 months followed by monthly booster group sessions for 3 months
Other Name: Cognitive Behavioral Therapy, CBT
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
Active Comparator: Intensive Smoking Intervention
IS: 12-week treatment with nicotine patch plus nicotine gum/lozenge. Intensive Smoking Intervention using smoking cessation counseling using Cognitive Behavioral Therapy, CBT, will include weekly individual sessions for 3 months followed by monthly booster group sessions 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 Smoking Intervention
Weekly individual CBT smoking cessation 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

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. Having both a usual care and intensive smoking cessation conditions will enable us assess the added benefits of intensive smoking intervention which has been shown in the general population but has never been studied in homeless populations. Adding alcohol treatment to 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: All three study conditions have identical number of contacts; the duration of counseling time is also identical in IS and IS+A conditions. We considered a design in which the duration of counseling in the UC will be identical to those in IS and IS+A conditions 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 monthly booster group sessions 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Currently Homeless
  • Smokes > or equal to 5 cigarettes per day in past 7 days
  • Smoked at least 100 cigarettes in lifetime
  • AUDIT score of > or equal to 8
  • Aged 18 years or older
  • Willing to attend study sessions and follow other study protocol

Exclusion Criteria:

  • Participation in previous Power to Quit research study
  • Use of smoking cessation medications or interventions in last 30 days
  • Unstable medical illness that requires immediate medical care
  • AUDIT score of < or equal to 7
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932996

Contacts
Contact: Kolawole S Okuyemi, MD, MPH (612) 625-1850 kokuyemi@umn.edu
Contact: Sara E Eischen, BA (612) 625-1654 bengt008@umn.edu

Locations
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Sara E Eischen, BA    612-625-1850    bengt008@umn.edu   
Principal Investigator: Kolawole S Okuyemi, MD, MPH         
Sub-Investigator: Anne M Joseph, MD         
Sub-Investigator: Janet L Thomas, PhD         
Sub-Investigator: Susan Everson-Rose, PhD         
Sub-Investigator: John E Connett, PhD         
Sub-Investigator: Nancy C Raymond, MD         
Sub-Investigator: Rebekah J Pratt, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Kolawole S Okuyemi, MD, MPH University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01932996     History of Changes
Other Study ID Numbers: 1307M39761, 2R01HL081522-05A1
Study First Received: August 27, 2013
Last Updated: August 27, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 20, 2014