Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of Patients Who Receive the Second Injection of XR-NTX.
研究概览
简要总结
The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient study of methods to facilitate induction and stabilization onto XR-NTX. There will be three different methods of XR-NTX induction using increasing doses of oral naltrexone and buprenophine.
详细描述
Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.
Procedure 2: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. No buprenorphine will be given beyond day 10.
Procedure 3: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. Buprenorphine will continue for 4 weeks until the 2nd XR-NTX dose.
All participants will receive weekly therapy with a study psychiatrist. All participants will receive open-label medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets DSM-5 criteria for current opioid use disorder (moderate-severe) of at least six months duration, supported by urine toxicology OR COWS score > or =6 OR Naloxone Challenge.
- •Voluntarily seeking treatment for opioid dependence.
- •In otherwise good health based on complete medical history and physical examination within normal ranges (AST or ALT < 3 times normal). )
- •Able to give written informed consent.
排除标准
- •Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per week).
- •Maintenance on, or regular use of buprenorphine or other long-acting narcotic agonists.
- •Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
- •Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with AST or ALT > 3 times normal, AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection), unstable diabetes.
- •Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-5 Schizophrenia or any psychotic disorder, severe Major Depressive Disorder, or suicide risk or 1 or more suicide attempts within the past year.
- •Physiologically dependent on alcohol or sedative- hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary.
- •History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
- •Chronic organic mental disorder (e.g. AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection) dementia).
- •History of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
- •Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications.
研究组 & 干预措施
Procedure 1
Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.
干预措施: Buprenorphine (Drug)
Procedure 1
Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.
干预措施: Naltrexone (Drug)
Procedure 1
Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.
干预措施: Vivitrol (Drug)
Procedure 2
Procedure 2: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. No buprenorphine will be given beyond day 10.
干预措施: Buprenorphine (Drug)
Procedure 2
Procedure 2: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. No buprenorphine will be given beyond day 10.
干预措施: Naltrexone (Drug)
Procedure 2
Procedure 2: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. No buprenorphine will be given beyond day 10.
干预措施: Vivitrol (Drug)
Procedure 3
Procedure 3: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. Buprenorphine will continue for 4 weeks until the 2nd XR-NTX dose.
干预措施: Buprenorphine (Drug)
Procedure 3
Procedure 3: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. Buprenorphine will continue for 4 weeks until the 2nd XR-NTX dose.
干预措施: Naltrexone (Drug)
Procedure 3
Procedure 3: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. Buprenorphine will continue for 4 weeks until the 2nd XR-NTX dose.
干预措施: Vivitrol (Drug)
结局指标
主要结局
Percentage of Patients Who Receive the Second Injection of XR-NTX.
时间窗: 4 weeks after 1st injection
Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX
次要结局
未报告次要终点
研究者
Adam Bisaga
Research Psychiatrist
New York State Psychiatric Institute