Enhancing Smoking Cessation in the Homeless Population
2020년 11월 17일 업데이트: 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.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (실제)
등록
352
단계
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Minnesota
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Minneapolis, Minnesota, 미국, 55414
- University of Minnesota
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: 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.
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12-week treatment with nicotine patch plus nicotine gum/lozenge
다른 이름들:
Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
다른 이름들:
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위약 비교기: 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
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12-week treatment with nicotine patch plus nicotine gum/lozenge
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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CO-verified Smoking Status at 26 Weeks
기간: 7-day smoking abstinence at week 26 follow-up
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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.
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7-day smoking abstinence at week 26 follow-up
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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CO-verified Smoking Status at 12 Weeks
기간: at weeks 12
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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.
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at weeks 12
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Self-Reported Continuous Alcohol Abstinence for 30 Days
기간: at week 26
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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.
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at week 26
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Pratt Rebekah, PhD, University of Minnesota
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
연구 시작
2015년 1월 1일
기본 완료 (실제)
기본 완료
2018년 10월 31일
연구 완료 (실제)
연구 완료
2018년 10월 31일
연구 등록 날짜
최초 제출
최초 제출
2013년 8월 27일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2013년 8월 27일
처음 게시됨 (추정)
처음 게시됨
2013년 8월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2020년 11월 19일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2020년 11월 17일
마지막으로 확인됨
마지막으로 확인됨
2020년 11월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 1307M39761
- 2R01HL081522-05A1 (미국 NIH 보조금/계약)
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