Evaluation of Naltrexone as a Treatment for Self-Injurious Behavior
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Comparison of self-injury rates by condition
研究概览
简要总结
The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in adolescents and adults of normal intelligence.
详细描述
The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in adolescents and adults of normal intelligence. It is designed as a pilot study and will provide preliminary data for a larger scale clinical trial if found to be effective in the pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thirteen years of age or older
- •Actively engaged in SIB at a rate of, on average, at least two events per week for at least 3 months
- •Has internet access in a secure and private manner
- •Lives within a reasonable distance from Kalamazoo (to make the five clinic visits convenient) and plans to remain in the area throughout the next 4-5 months
排除标准
- •Under the age of 13
- •Currently pregnant (confirmed with initial urine pregnancy test), lactating, or planning to become pregnant in the next 4 months
- •Active hepatitis or liver disease
- •Prior history of recently active opioid dependence
- •Current prescription, non-prescription, or illicit opioid use, (i.e., acute use within the past 14 days or chronic use within the last 30 days), including all opioid analgesics, certain cough and cold remedies (e.g., codeine), and certain anti-diarrheal preparations (e.g., loperamide). Currently taking an opioid antagonist for alcohol or opioid dependence or having taken one in the last 14 days
- •Current use of leflunomide (Arava), droperidol (Droleptan), diazepam (Valium), thioridazine (Mellaril, Novoridazine, Thioril) (26)
- •Any report of clinically significant medical condition or medication regimen which might cause undue risk or affect ability to participate in this clinical trial
- •On initial laboratory examination, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than one standard deviation (SD) above the upper limit of normal
- •Unable to meet a 22-week requirement to log journal entries daily, to be available by phone a minimum of once weekly during the first month, and to be present at clinical sites once every three weeks for 12 weeks, for a total of 5 visits
- •Infrequent SIB, lack of secure Internet access, or living a significant distance from the Kalamazoo area (does not meet inclusion criteria)
- •Unwilling or parent/guardian unwilling to participate in research requirements.
研究组 & 干预措施
Group 1 A-ABAB
After 4 week open label oral naltrexone run-in, participants are randomized to 2 groups (50% each). Group 1 will receive oral naltrexone 50 mg daily during weeks 5-7 (3 weeks). They will switch to placebo for weeks 8-10, then return to naltrexone for weeks 11-13, then placebo for weeks 14-16 (i.e., A-ABAB double crossover design, participants act as own controls). Study drug and placebo will be encapsulated so as to appear identical.
干预措施: Naltrexone (Drug)
Group 1 A-ABAB
After 4 week open label oral naltrexone run-in, participants are randomized to 2 groups (50% each). Group 1 will receive oral naltrexone 50 mg daily during weeks 5-7 (3 weeks). They will switch to placebo for weeks 8-10, then return to naltrexone for weeks 11-13, then placebo for weeks 14-16 (i.e., A-ABAB double crossover design, participants act as own controls). Study drug and placebo will be encapsulated so as to appear identical.
干预措施: Placebo (Other)
Group 2 A-BABA
After 4 week open label oral naltrexone run-in, participants are randomized to 2 groups (50% each). Group 2 will receive oral placebo once daily during weeks 5-7. They will then be switched to oral naltrexone 50 mg daily for weeks 8-10, then return to placebo for weeks 11-13, then naltrexone for weeks 14-16 (i.e., A-BABA double crossover design, participants act as own controls). Study drug and placebo will be encapsulated so as to appear identical.
干预措施: Naltrexone (Drug)
Group 2 A-BABA
After 4 week open label oral naltrexone run-in, participants are randomized to 2 groups (50% each). Group 2 will receive oral placebo once daily during weeks 5-7. They will then be switched to oral naltrexone 50 mg daily for weeks 8-10, then return to placebo for weeks 11-13, then naltrexone for weeks 14-16 (i.e., A-BABA double crossover design, participants act as own controls). Study drug and placebo will be encapsulated so as to appear identical.
干预措施: Placebo (Other)
结局指标
主要结局
Comparison of self-injury rates by condition
时间窗: For each 3 week trial, average rates calculated over weeks 2-3 only (14 day period).
naltrexone rate vs. placebo rate
次要结局
- Comparison of self-injury rates by trial within condition(Average rates calculated for weeks 2-3 of each 3 week trial (14 day period))