- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00461890
Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial
The goal of the proposed project is to improve the primary care treatment of veterans with alcohol dependence. Alcohol dependence is a common behavioral health problem among veterans treated in VA primary care clinics. However, assessment and treatment of alcohol dependence in primary care remains problematic. Assessment of veterans with positive alcohol use screens may not always be completed and referrals to specialty care may not always be made. Moreover, the use of medications for alcohol dependence among veterans is rare, despite VA treatment guidelines that recommend such use. Finally, when medications are prescribed, patients may have difficulties with adherence.
The primary aim of this study is to assess the feasibility of long-acting injectable naltrexone provided through primary care (LAN/PC) versus long-acting injectable naltrexone in the specialized chemical dependence clinic (LAN/CDC). The secondary aim is to obtain preliminary assessments of the relative effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
연구 개요
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 장소
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New York
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Syracuse, New York, 미국, 13210
- Syracuse VAMC
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants must be males or non-pregnant females between the ages of 18 and 69 who are receiving their primary medical care at the Syracuse VAMC.
- Participants must meet DSM-IV diagnostic criteria for current alcohol dependence.
- Participants must report drinking within the thirty days prior to study entry.
- Participants must receive approval from their primary care provider for study participation.
- Participants must be willing to consider accepting at least one of the two treatment conditions.
Exclusion Criteria:
- Participants with a current DSM-IV diagnosis of current opioid abuse or dependence, or in opioid withdrawal
- AST level is greater than 3 times the upper limit of the normal range
- Participants with a medical condition requiring opioid medication or a severe allergy to naltrexone
- Participants who received outpatient treatment at the Syracuse VA Chemical Dependence Clinic in the past 90 days
- Any unstable medical or psychiatric conditions in the judgment of the principal investigator or the participants primary care provider
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Primary Outcomes: Feasibility of an injectable naltrexone study in the primary care setting.
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2차 결과 측정
결과 측정 |
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Secondary Outcome: Effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Steven L Batki, M.D., Executive Director VA Center for Integrated Healthcare, Syracuse VA Medical Center
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Syracuse VA IRB #00364
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. .
Injectable Naltrexone에 대한 임상 시험
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Hacettepe University모집하지 않고 적극적으로
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New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA); Research Foundation for Mental Hygiene, Inc.완전한마리화나 사용
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Marta Peciña, MD PhDBrain & Behavior Research Foundation완전한
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Weill Medical College of Cornell UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)종료됨
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University of Vermont Medical CenterNational Institute on Drug Abuse (NIDA)완전한
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University of NebraskaInCor Heart Institute; VU University of Amsterdam완전한