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临床试验/ISRCTN69313751
ISRCTN69313751已完成未知

The Addiction Recovery Clinic (ARC): personalised behavioural intervention for opioid use disorder: a randomised controlled trial

King's College London (UK)0 个研究点目标入组 380 人开始时间: 2013年5月23日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
380

研究概览

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Current inclusion criteria as of 02/05/2017:
  • 1. 18 years of age or older (no upper limit, but generally <60yrs)
  • 2. Undergoing treatment at Lorraine Hewitt House for a minimum of 6 weeks by the date of randomisation
  • 3. Able to comprehend English to the extent required by the study protocol
  • 4. Demonstrates verbal understanding of the study patient information material
  • 5. Able to provide written consent and can understand and confirm willingness to comply with the protocol
  • 6. Current diagnosis of opioid dependence
  • 7 .Currently prescribed methadone or buprenorphine mono or combination therapy
  • 8. Self reported use heroin and/or cocaine use (verified by urine drug screen toxiology test)
  • 9. Voluntarily seeking treatment and able to attend the clinic as described in the protocol
  • 10. Lives in sufficiently stable accommodation in the community, with a personal phone
  • 11. Can nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number which we can call to assist as necessary with the arrangement of follow-up appointments
  • Previous inclusion criteria:
  • 1. 18 years of age or older (no upper limit, but generally <60 years)
  • 2. Undergoing treatment at Lorraine Hewitt House for a minimum of 6 weeks by the date of randomisation
  • 3. Able to comprehend English to the extent required by the study protocol
  • 4. Demonstrates verbal understanding of the study patient information material
  • 5. Able to provide written consent and can understand and confirm willingness to comply with the protocol
  • 6. Current diagnosis of opioid dependence
  • 7 .Currently prescribed methadone or buprenorphine mono or combination therapy
  • 8. Voluntarily seeking treatment and able to attend the clinic as described in the protocol
  • 9. Lives in sufficiently stable accommodation in the community, with a personal phone
  • 10. Can nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number which we can call to assist as necessary with the arrangement of follow-up appointments

排除标准

  • 1. Clinically significant medical conditions other than addiction that may compromise subject safety or study conduct; or any abnormality which, in the investigator's judgment, is clinically significant.
  • 2. Current criminal justice involvement with legal proceedings and in the opinion of the chief Investigator, is expected to fail to complete the study protocol due to incarceration or relocation from the centre's catchment area
  • 3. Current (past 30 day) suicidal planning or recent (past six months) suicidal ideation or suicide attempt
  • 4. Active, uncontrolled severe mental illness (e.g. psychosis, bipolar I disorder, schizoaffective disorder - addressed in routine admissions protocol) and/or a history or evidence of organic brain disease or dementia that would compromise the participant's ability to comply with the study protocol
  • 5. Has been in any research study in the past 30 days or an intervention research study in the past 6 months

研究者

发起方
King's College London (UK)

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