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Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking

2018년 5월 2일 업데이트: Michael Stein, MD, Butler Hospital

Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers

RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.

PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

OBJECTIVES:

Primary

  • To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher rate of smoking cessation than combination nicotine replacement therapy with nicotine patch prescription plus ad libitum nicotine gum delivery in methadone-maintained smokers.

Secondary

  • To test the effects of the treatments on smoking urges, withdrawal symptoms, and reinforcing effects of smoking.
  • To test the effects of the treatments on methadone treatment outcomes, including retention in methadone maintenance, methadone dose changes, and continued use of illicit drugs as measured by urine toxicologies.

OUTLINE: This is a multicenter study. Patients are stratified based on gender and level of nicotine dependence. Patients are randomized to 1 of 3 intervention arms.

At baseline, all patients receive a minimal behavioral intervention using a 3-minute, simple smoking cessation counseling strategy, a self-help manual, and a telephone quit-line number.

  • Arm I (varenicline): Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
  • Arm II (placebo): Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
  • Arm III (nicotine patch/gum): Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.

Patients complete a brief interview over 10-15 minutes at 2 weeks and monthly during months 1-5. They complete a longer interview over 45 minutes at months 6 and 12 and provide breath samples (for carbon monoxide monitoring) and urine samples (for cotinine testing).

NOTE: Smoking cessation may prevent certain smoking-related illnesses, including cancer.

PROJECTED ACCRUAL: A total of 602 patients (258 receiving varenicline, 258 receiving nicotine replacement therapy, and 86 receiving placebo) will be accrued for this study.

연구 유형

중재적

등록 (실제)

315

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Rhode Island
      • Providence, Rhode Island, 미국, 02903
        • Rhode Island Hospital Comprehensive Cancer Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

INCLUSION CRITERIA

  • Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)

  • Interested in quitting smoking

    • Willing to set a quit date 7 days after baseline assessment

  • Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions:

    • Codac, Inc. (with two independent sites)
    • Addiction Recovery Institute
    • Center for Treatment and Recovery
    • Discovery House
  • Has received methadone for at least the past month

EXCLUSION CRITERIA

  • Pregnant or nursing (Must have negative pregnancy test)
  • Non-English speaking
  • No personal telephone or does not live close to a relative or neighbor with a telephone
  • Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review
  • Unvailable for this study for the next 12 months
  • Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension)
  • Active skin condition (e.g., psoriasis)
  • History of skin allergy
  • History of a suicide attempt
  • Working as pilots, drivers, or operators of heavy machinery

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent insulin or blood thinners
  • No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Arm I
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
의약품: varenicline
Given orally
위약 비교기: Arm II
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
다른: 위약
구두로 주어진
활성 비교기: Arm III
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
의약품: nicotine
Given transdermally and orally

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Self- Reported 7-day Abstinence
기간: 6 Months
Number of participants with self-reported, 7-day abstinence at 6-months
6 Months
Carbon Monoxide (CO)-Confirmed 7-day Abstinence
기간: 6-Months
Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.
6-Months
Rates of Smoking Cessation Continuous From First Quit Day to 6 Months
기간: 6-Months
Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months
6-Months
Self-reported 7-day Abstinence
기간: 12 Months
Number of participants with self-reported 7-day abstinence at 12-months
12 Months
CO-confirmed 7-day Abstinence
기간: 12 Months
Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.
12 Months

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Smoking Urges
기간: 6 months
Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score.
6 months
Withdrawal Symptoms
기간: 6 months
Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score.
6 months
Retention in Methadone Maintenance
기간: 12 months
12 months
Methadone Dose Changes
기간: 12 months
12 months
Use of Illicit Drugs as Measured by Urine Toxicologies
기간: 12 months
12 months
Reinforcing Effects of Smoking
기간: 6 months
Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score.
6 months
Change in Cigarettes Per Day
기간: 6-Months
Change in mean cigarettes per day
6-Months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Butler Hospital

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: Michael Stein, MD, Butler Hospital

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

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

2008년 9월 1일

기본 완료 (실제)

2012년 10월 1일

연구 완료 (실제)

2012년 10월 1일

연구 등록 날짜

최초 제출

2008년 11월 11일

QC 기준을 충족하는 최초 제출

2008년 11월 12일

처음 게시됨 (추정)

2008년 11월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 6월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 5월 2일

마지막으로 확인됨

2018년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CDR0000616663
  • R01CA129226 (미국 NIH 보조금/계약)
  • BUTLER-0807-004

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. .

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