- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01347112
Varenicline Treatment for Active Alcoholic Smokers
Alcohol dependence is a significant and prevalent public health problem affecting approximately 4% of the U.S. adult population. Individuals with alcohol dependence actively seek treatment annually, and long-term alcohol abstinence varies from 40-60%. Because of the high smoking prevalence and trends toward heavier smoking, alcoholic smokers are at high risk for both morbidity and mortality related to alcohol consumption and tobacco dependence. Although several studies have evaluated pharmacotherapy for tobacco dependence in recovering alcoholic smokers, few have evaluated pharmacotherapy for tobacco dependence among currently drinking alcoholic smokers.
Varenicline is the most effective medication currently available for treating tobacco dependence. While some randomized trials have included recovering alcoholics, active alcoholism has been an exclusion criteria for these trials. Thus, this proposal would be the first such clinical trial in currently drinking alcoholic smokers. In addition to helping smokers to stop smoking, varenicline has also been shown to reduce alcohol consumption in rats. The goal of this proposal is to explore the potential efficacy of varenicline for treating tobacco dependence and reducing drinking among alcohol dependent smokers.
The investigators hypothesize that 12 weeks of treatment with varenicline, a partial nicotinic acetylcholine receptor agonist will be more effective than placebo in treating tobacco dependence and reducing nicotine withdrawal symptoms in currently drinking alcoholic smokers. The investigators will also explore whether varenicline has an effect on drinking behavior among currently drinking alcoholics. The investigators propose the following specific aims to test these hypotheses in 70 currently drinking alcoholic smokers recruited at the Mayo Clinic in Rochester, Minnesota.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic in Rochester
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Wisconsin
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La Crosse, Wisconsin, 미국, 54601
- Franciscan Skemp Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or non-pregnant female cigarette smokers 18-years-of-age or older and reporting smoking at least an average of 10 cigarettes per day for the past year;
- Subject is alcohol dependence based on DSM IV criteria as assessed by the Mini-International Neuropsychiatric Interview (MINI) and the physician investigator;3
- Subject is currently drinking alcoholic beverages as assessed by the physician investigator;
- Subject is a female subject of non-childbearing potential or a female subject of childbearing potential - who is using contraceptives and has a negative pregnancy test result;
- Subject must be able to complete all the study visits;
- Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments;
- Subject must be in good general health as determined by medical history, physical exam and physician investigator;
- Subject must provide written informed consent to participate in the study;
Exclusion Criteria:
- Subject is a female who is pregnant, lactating or likely to become pregnant during the trial and not willing to use an acceptable form of contraception during the medication phase, (for women of child-bearing potential, a pregnancy test will be performed prior to entry into the study and at the end of the medication phase);
- Subject has another household member in study;
- Known allergy to varenicline;
- Subject is currently (in previous 30 days) using other behavioral or pharmacologic tobacco cessation program (i.e., behavioral therapy, nicotine replacement therapy, clonidine, varenicline, bupropion SR, nortriptyline or doxepin) and unwilling or unable to discontinue use;
- Subject has an unstable medical condition as determined by the physician investigator;
- Subject describes having a medical history of: a) unstable angina; b) myocardial infarction within the past 3 months; c) coronary angioplasty or d) an untreated cardiac dysrhythmia;
- Subject has a personal history of renal failure or is on renal dialysis;
- Subject has a current moderate or severe depression as assessed by the Center for Epidemiologic Studies-Depression survey (CES-D) and physician investigator;
- Subject has, as defined by the Columbia Suicide Severity Rating Scale (C-SSRS) current non-specific suicidal thoughts, or have a lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act");
- Subject has current (past 30 days) major depressive disorder or has a history of another psychiatric disorder such as psychosis or bipolar disorder;
- Subject currently uses of other tobacco products (i.e. pipe, cigar, smokeless tobacco) within the past 30 days;
- Subject currently has cancer [excluding non melanoma skin cancer] not in remission (cancer free for 5 years or more);
- Subject currently has Type 1 diabetes;
- Subject has untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100;
- Subject is currently on treatment with another investigational drug (within 30 days of study entry);
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Varenicline
varenicline 1.0 mg twice daily for 12 weeks
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varenicline 1.0 mg dose, twice daily for 12 weeks
다른 이름들:
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위약 비교기: Sugar Pil
Varenicline look alike sugar pill twice daily for 12 weeks
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sugar pill twice daily for 12 weeks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment
기간: 12 weeks
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Prolonged smoking abstinence will be identified by a negative response to the question, "Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"
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12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Prolonged Abstinence at 24 Weeks
기간: week 24
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Prolonged abstinence is identified by a negative response to the question, "Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"
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week 24
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Heavy Drinking Days at End of Treatment
기간: week 12
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Heavy drinking is defined as 5 standard alcohol drinks or greater for men and 4 standard alcohol drinks or greater for women.
The number of heavy drinking days per month was determined using the timeline follow-back method.
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week 12
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Richard D. Hurt, MD, Mayo Clinic
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Varenicline에 대한 임상 시험
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University of PennsylvaniaNational Cancer Institute (NCI); Northwestern University모병
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Thomas Jefferson University모집하지 않고 적극적으로