NCT01262092已完成2 期
Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Illicit Opioid Use as Determine by Urine Dipsticks
研究概览
简要总结
This study involves inducting treatment seeking opioid dependent participants onto buprenorphine. Once the participant reaches a stable dose they will receive either placebo or gabapentin to determine if gabapentin helps ease withdrawal symptoms while the participant undergoes a 10-day buprenorphine detoxification.
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
- Double (Participant, Investigator)
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
- •Availability to attend clinic 6 days a week for approximately 30-60 minutes.
- •Participants must fulfill DSM-IV criteria for opioid dependence. These criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on several clinical assessments that are routinely employed by methadone program physicians, including history and severity of opioid use, presence of track marks, prior treatment history, self-reported and/or observed signs and symptoms of opioid withdrawal. If any individual's degree of opioid dependence is questionable, that person will be excluded from further consideration as a participant.
- •Participants must submit a urine negative for drugs of abuse other than opioids prior to starting the study.
排除标准
- •Unstable medical condition or stable medical condition that would interact with study medications or participation.
- •History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
- •Pregnancy or plans to become pregnant or inadequate birth control (adequate birth control includes abstinence, condoms, birth control pills, etc).
- •Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or drug (including Maalox) that would have major interaction with drugs to be tested.
- •Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
- •EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged QTc interval (>450 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.
- •Physical dependence on alcohol or drugs other than opioids or tobacco (as determined by physician assessment).
研究组 & 干预措施
Gabapentin
Active Comparator
Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
干预措施: Buprenorphine (Drug)
Placebo
Placebo Comparator
Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Illicit Opioid Use as Determine by Urine Dipsticks
时间窗: 3x weekly during wks 3 and 4
urine data are from those obtained during the buprenorphine taper
次要结局
未报告次要终点
研究者
研究点 (1)
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