Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Subjective Opioid Withdrawal Total Adjective Score
研究概览
简要总结
Prescription opioid addiction is a growing public health problem and more pharmacologic treatments are needed because current approved medications have had limited patient acceptance (naltrexone), limited availability (methadone), and concerns about misuse and diversion (methadone and buprenorphine). Tramadol is a currently approved medication used to treat moderate-severe pain, and initial studies demonstrate that it may be useful for treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric effects. This study will determine whether two different doses of extended release tramadol can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no longer taken.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Addicted to opioids
排除标准
- •Any major medical or psychiatric disorder that would be contraindicated for participation
研究组 & 干预措施
Tramadol 200 mg then placebo
Tramadol 200 mg daily for 1 week then placebo given for 1 week
干预措施: Tramadol (Drug)
Placebo for two weeks
Medication
干预措施: Placebo (Drug)
Tramadol 600 mg then placebo
Tramadol 600 mg daily given for 1 week given then placebo given for 1 week
干预措施: Tramadol (Drug)
结局指标
主要结局
Subjective Opioid Withdrawal Total Adjective Score
时间窗: Days 1-7
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1
时间窗: Days 1-7
There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.
Subjective Opioid Withdrawal Adjective Total Score Week 2
时间窗: days 8-13
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2
时间窗: Days 8-13 (all groups now on placebo)
There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.
次要结局
未报告次要终点
研究者
Michelle Lofwall
Principal Investigatory
University of Kentucky