NCT01560442Unknown不适用
Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine.
University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measurement of the pupil diameter
研究概览
简要总结
The purpose is to study the relation between pupillary diameter measured under scotopic conditions, and the pain thresholds measured at the time of peak and residual effect of methadone/buprenorphine in opiate-dependent patients following a substitution program.
详细描述
Patients substituted since at least 3 months shall be included during a regular control visit.
Each session shall consist in
- check for toxics in urine sample;
- measurement of pupil diameter;
- measurement of mechanical punctuate pain threshold;
- measurement of mechanical bone pain threshold.
A first session shall be done at time of residual effect of the opiate. A second session shall be done at time of peak effect of the opiate.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
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
- •substitution treatment stable since at least 3 months
- •capacity to understand the protocol
- •likely to come to visits
- •covered by French welfare
排除标准
- •chronic pain
- •concomitant acute pain
- •pregnancy or breast feeding
- •relevant mental disease
- •peripheral neuropathy
- •regular intake of ketamine
- •neuroleptic concomitant treatment
研究组 & 干预措施
buprenorphine
干预措施: Buprenorphine and Methadone Hydrochloride (Drug)
Methadone Hydrochloride
干预措施: Buprenorphine and Methadone Hydrochloride (Drug)
结局指标
主要结局
Measurement of the pupil diameter
时间窗: 24 hours after the last dose of treatment
次要结局
- - The mechanical punctuate pain threshold as measured by Electronical Von Frey(24 hours after the last dose of treatment, 3 hours after the last dose of methadone and 1 hour ½ after the last dose of buprenorphine)
- - The mechanical pressure pain threshold measured by Algometer on the tibial bone(24 hours after the last dose of treatment, 3 hours after the last dose of methadone and 1 hour ½ after the last dose of buprenorphine)
- - The pupil diameter measured in scotopic .conditions (via infrared camera) at the hypothetical peak effect of either methadone or buprenorphine.(24 hours after the last dose of treatment, 3 hours after the last dose of methadone and 1 hour ½ after the last dose of buprenorphine)
- - The pupil diameter measured in photopic conditions (via infrared camera) at the hypothetical residual effect of either methadone or buprenorphine(24 hours after the last dose of treatment, 3 hours after the last dose of methadone and 1 hour ½ after the last dose of buprenorphine)
研究者
研究点 (1)
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