- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02896400
Optimizing Tobacco Dependence Treatment in the Emergency Department
연구 개요
상태
정황
상세 설명
The investigators propose to optimize the identification and treatment of adult smokers seen in a hospital ED. To do this the Multiple Optimization Strategy (MOST) will be employed to develop a multicomponent intervention that will consist of some combination of the following: (1) a Brief Negotiation Interview (BNI, a variant of a motivational interview), delivered by a trained research assistant; (2) provision of 6 weeks of nicotine patches and gum to the research participant, with application of the first patch in the ED (NRT); (3) active referral to the Connecticut Smokers' Quitline (QL); and (4) enrollment in the SmokefreeText a short-messaging service (SMS) texting program for mobile phones (Text). Using MOST principles, the first phase of the study will use a 2x2x2x2 full-factorial design to identify the components most likely to be efficacious in combination. Although the factorial design requires the allocation of participants to 16 different combinations of the 4 components (Table 1), evaluation of each individual component is performed comparing all of those receiving a component to all of those not receiving a component, making this an efficient design. For instance, evaluation of the BNI component will compare those randomized to arms 1 through 8 to those in arms 9 to 16.The second phase will consist of designing and proposing a 2-arm randomized clinical trial comparing the efficacy of the multicomponent intervention package to usual care; this will be conducted in a future application.
The specific aims of this proposed study are:
Aim 1. To conduct a fully powered factorial randomized trial of 1056 adult smokers to test the efficacy of 4 key components of ED-initiated tobacco treatment: Brief Negotiated Interview (BNI), nicotine replacement therapy (NRT), Quitline referral (QL), and SmokeFreeText (Text).
Aim 2. To identify the most efficacious components of our intervention, within fixed constraints of cost effectiveness and feasibility/acceptability to providers and subjects.
Aim 3. To lay the groundwork for a future randomized trial testing the previously identified components, delivered as a package, against a control arm in a new cohort of adult ED smokers.
Our associated hypotheses are:
- At 3 months, at least 1 intervention component will yield a biochemically verified tobacco abstinence rate at least 5% greater than in the control condition. Carbon monoxide breath test will be used for biochemical verification.
- At 3 months, at least 1 intervention will be cost-effective, using a societal perspective.
- At 3 months, at least 1 intervention will be acceptable and feasible to providers and subjects.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
Connecticut
-
New Haven, Connecticut, 미국, 06519
- Yale School of Medicine
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 years or older
- have smoked >= 100 cigarettes lifetime
- describe themselves as every or some day smokers
- smoke at least 5 cigarettes/day
- own a cellphone with texting capability
- are able to give written informed consent
Exclusion Criteria:
- Inability to read or understand English
- currently receiving formal tobacco dependence treatment
- life-threatening or unstable medical, surgical, or psychobehavioral condition
- unable to provide at least one collateral contact
- live out-of-state
- leaving the ED against medical advice
- pregnant (self-report or urine testing), nursing, or trying to conceive.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: BNI+NRT+QL+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
|
Brief motivational interview on smoking behavior
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
실험적: BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
|
Brief motivational interview on smoking behavior
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
|
실험적: BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
|
Brief motivational interview on smoking behavior
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
실험적: BNI+NRT
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
|
Brief motivational interview on smoking behavior
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
|
실험적: BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
|
Brief motivational interview on smoking behavior
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
실험적: BNI+QL
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)
|
Brief motivational interview on smoking behavior
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
|
실험적: BNI+Text
Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)
|
Brief motivational interview on smoking behavior
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
실험적: BNI only
Brief Negotiated Interview (BNI)
|
Brief motivational interview on smoking behavior
|
실험적: NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
|
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
실험적: NRT+QL
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
|
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
|
실험적: NRT+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
|
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
실험적: NRT only
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
|
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
|
실험적: QL+Text
Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
|
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
실험적: QL only
Referral to CT Smokers Quitline (QL)
|
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
|
실험적: Text only
Registration in SmokefreeText (Text)
|
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
간섭 없음: Control
Control arm, no intervention
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Tobacco Abstinence
기간: 3 months
|
Abstinence self reported and verified by exhaled carbon monoxide
|
3 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Steven L Bernstein, MD, Yale School of Medicine, Department of Emergency Medicine
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1603017332
- 1R01CA201873-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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