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NCT01932996 · ClinicalTrials.gov registry record · Phase 4
Enhancing Smoking Cessation in the Homeless Population
A Phase 4 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 4
- Development phase
- 352
- Enrollment target
NCT01932996: Completed Phase 4 study, sponsored by University of Minnesota.
NCT01932996 is a Phase 4 study that has completed, run by University of Minnesota. The registered enrollment target is 352 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01932996, a Phase 4 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 352 participants
- Enrollment target
Study 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, o
Primary Outcome
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.
Interventions
- DRUG nicotine patch plus nicotine gum/lozenge
- BEHAVIORAL Intensive Alcohol Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2015-01 |
| Est. Completion | 2018-10-31 |
| Phase | Phase 4 |
What the finished NCT01932996 record still lists
NCT01932996 is an interventional study that assigns participants to a tested intervention. The registered 352 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which nicotine patch plus nicotine gum/lozenge is the first listed.
NCT01932996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01932996 about?
NCT01932996 is a clinical study titled "Enhancing Smoking Cessation in the Homeless Population". 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...
What is the current status of trial NCT01932996?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 352 participants. The study started on 2015-01. Estimated completion is 2018-10-31.
What interventions are being tested in trial NCT01932996?
The interventions under investigation include: nicotine patch plus nicotine gum/lozenge (DRUG), Intensive Alcohol Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01932996?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01932996's enrollment target sits among peer trials
352 229th of 2000 higher than 1,771 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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