A Novel Methadone-induced Memory Retrieval-extinction Procedure to Prevent Heroin Craving and Relapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 主要终点
- change of negative urinary morphine test
研究概览
简要总结
The study assessed the efficacy of a methadone-induced memory retrieval-extinction procedure on heroin craving and relapse. Male participants aged 18-55 years old and prescribed MMT to treat heroin dependence were included in the present study, and randomly assigned to receive methadone, or receive methadone plus 10 minutes plus extinction, or receive methadone plus 6 hours plus extinction. The intervention persisted 3 times per week for 4 weeks. Then the subjects were followed up once a month for cue induced heroin craving and relapse.
详细描述
In the present study, we explored the effect retrieval-extinction procedure on heroin craving and relapse in heroin addicts using the methadone (a commonly used µ-opioid receptor agonist) instead of heroin as the trigger to reactivate drug memories. The subjects were randomly divided into 3 groups, in which they received methadone alone or extinction sessions 10 min or 6 hours after methadone administration. The extinction sessions were given 3 times per week for 4 weeks, each lasted for 30 min. During the extinction procedure, the subjects were exposed to images, heroin paraphernalia and mimic heroin. Subjective craving, morphine urine test and physiological responses were recorded monthly for 4 months.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •met the diagnostic criteria of heroin dependence according to DSM-IV
- •were prescribed methadone maintenance treatment (MMT) and took it regularly
- •no change in city of residence for at least 1 year
- •had normal blood pressure and heart rate
- •had negative urine morphine screening test
- •primary-school level education
- •provide signed consent
排除标准
- •other substance abuse(except nicotine)
- •had a current or past history of Diagnostic and Statistical Manual of Mental Disorders, 4th Edition（DSM-IV) AxisⅠdisorders
- •had clinically evident physical disorders
- •neurological signs and/or history of neurological disease
- •noncompliance with the procedure
研究组 & 干预措施
Methadone
The subjects take methadone as usual.
Methadone-10min-Extinction
The subjects were given extinction training 10 min following methadone administration.
干预措施: methadone induced memory retrieval-extinction procedure (Behavioral)
Methadone-6h-Extinction
The subjects were given extinction training 6h following methadone administration.
干预措施: methadone induced memory retrieval-extinction procedure (Behavioral)
结局指标
主要结局
change of negative urinary morphine test
时间窗: Baseline (Day 0), weekly during intervention(1, 2, 3 and 4 week) and monthly during follow-up for 4 months (2, 3, 4 and 5 month)
All the participants will be required to have urine tests for morphine during screening, weekly during intervention and monthly during follow-up.
change of cue induced heroin craving
时间窗: Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)
Heroin craving will be assessed using a visual analog scale (VAS), i.e., an undivided line marked at the left and right ends with 0 ("not at all") and 10 ("extremely high").
次要结局
- cue induced heart rate change(Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month))
- cue induced blood pressure change(Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month))