An Open Label, Flexible Dose Study of Very Low Doses of Naltrexone-Buprenorphine Transfer to Extend-Release Naltrexone (VIVITROL®) in Opioid Addiction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Retention in Treatment
研究概览
简要总结
The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol). The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding the treatment acceptable and showing minimal withdrawal discomfort.
详细描述
Thirty-five opioid dependent (OD) volunteers seeking treatment will be enrolled in an open-label, flexible-dosing, outpatient trial at Duke Addictions Program. On days 1-3, participants will receive buprenorphine/naloxone daily at a starting dose of 4mg, progressively decreasing to 2 mg on days 2- 3. Participants will also receive very low dose naltrexone (VLNTX) at a dose of 0.25 mg to 1mg on Days 1-3, 2 to 6 mg on Day 4 and between 10 and 50 mg on Days 5-7. Then a VIVITROL injection, 380 mg, will be administered on Day 8.
Evaluations will occur daily for up to 6 hours until 1 day after VIVITROL injection and then weekly for 4 weeks. Patients will receive ancillary medications as needed and weekly psychosocial intervention. At the end of the study, participants will be offered outpatient treatment of OD at the study site, or will be referred to other treatment programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18 to 65 years of age who meet DSM-IV criteria for OD of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
- •Individuals must be capable of giving informed consent and capable of complying with study procedures.
- •Participants will be asked to provide locator information including the address and telephone number of a non-drug abusing relative or friend who can reach the participant in emergencies.
排除标准
- •Individuals currently prescribed or regularly taking opiates for chronic pain or medical illness.
- •Individuals regularly using licit or illicit methadone or BUP.
- •Individuals meeting DSM-IV criteria for schizophrenia, schizoaffective or psychotic disorders, or psychiatric disorder (other than substance abuse) requiring intervention.
- •Individuals who are medically unstable, or have liver enzyme function tests greater than two times normal.
- •Individuals with current suicidal risk or 1 or more suicide attempts within the past year.
- •History of accidental drug overdose in the last three years or any other significant history of overdose following detoxification, defined as an episode of opioid-induced unconsciousness or incapacitation.
- •Nursing/pregnant women, or failure in a sexually active man or woman to use adequate contraceptive methods (e.g., oral or depot contraceptives, foam, sponges, and/or condoms)
- •Individuals who are dependent on any other drugs (excluding nicotine)
- •Individuals with known sensitivity to BUP, VIVITROL, NTX, naloxone.
- •Individuals who are court-mandated to treatment.
- •Individuals who have a current or pending legal status, or any other condition that would make them unlikely to be available for the duration of the study.
研究组 & 干预措施
BUP/VLNXT to VIVITROL
On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
干预措施: very low dose naltrexone (Drug)
BUP/VLNXT to VIVITROL
On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
干预措施: extended release naltrexone (Drug)
BUP/VLNXT to VIVITROL
On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
干预措施: buprenorphine/naloxone (Drug)
结局指标
主要结局
Retention in Treatment
时间窗: 4 weeks
After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks.
次要结局
- Percentage of Participants Who Adhered to Study Visits.(baseline to end of study (approximately 40 days))
- Percentage of Participants With Adherence to Medication (Naltrexone)(Day 1 to Day 8 (+/- 2 days))
- Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire(Day 9)
- Use of Ancillary Medications.(baseline to week 1)
- Number of Participants That Self Reported Illicit Drug Use(4 weeks)
- Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)(4 weeks)
- Craving(4 weeks)
- Illicit Drug Use, Measured by Urine Drug Testing(4 weeks)
- Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)(4 weeks)
研究者
Paolo Mannelli
Associate Professor of Psychiatry
Duke University