Efficacy of Mindfulness-based Relapse Prevention With or Without Vortioxetine on the Prevention of Relapse in Chronic Methamphetamine Users
试验速览
- 阶段
- 4 期
- 入组人数
- 220
- 主要终点
- The Timeline Followback (TLFB) for MA relapse rates
研究概览
简要总结
This multicenter, double-blind, Randomized, parallel-group study in subjects with methamphetamine dependence was to assess the efficacy of MBRP combined with vortioxetine and MBRP alone on 24-week abstinence rates, improvement of cognition and depressive symptoms.
详细描述
Participants who allocate to the experimental group will receive 8-week 10-20mg/day vortioxetine combined with MBRP intervention. Participants who allocate to the control group will receive 8-week 1-2#/day placebo combined with MBRP intervention.
Vortioxetine (Brintellix®), a novel antidepressant for the treatment of adult with major depressive disorder, has been approved by the Chinese Food and Drug Administration in the use of China in 2018.
The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists to prevent MA relapse. In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component. Group sessions include discussions of mindfulness as a means of coping with MA craving, negative affect and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice and implement practice into high-risk situations and in daily life, as well as homework assignments.
Participants from both groups will also receive 10 visits: visit 1 (week 0): medical and psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse rates), assessment of depressive symptoms, improvement in cognition and MA craving.
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
- •DSM-V diagnosis of MA dependence within the last year
- •completion or scheduled completion (i.e., within 2 weeks) of inpatient or intensive outpatient treatment for MA dependence.
- •express a wish to remain abstinent from MA use
- •be age 18 to 65
- •be fluent in speaking Mandarin and literate in Chinese and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of mindfulness techniques
- •willingness to randomization and attendance at treatment and assessment sessions
- •be able to attend all clinic visits without interruption
- •score greater than 16 on the HAM D17 and MADRS >= 26, as well as currently not on any psychotropics for treatment of depression
排除标准
- •Any current Axis I DSM-V psychiatric disorder other than MA or nicotine dependence that, in the clinician's opinion, warrants treatment or would preclude safe participation in the protocol, including, but not limited to: psychosis, schizophrenia, dementia, schizotypal personality disorder, borderline personality disorder, bipolar disorder, primary diagnosis of eating disorder, or chronic suicidality or homicidality, mental retardation et al.
- •Serious medical comorbidity requiring medical intervention or close supervision, including pacemakers, heart transplant, severe arrhythmias, or active atrial fibrillation, gross neurological disease
- •Suicide attempt in the last 3 months
- •Pregnant or breastfeeding women
- •Prior treatment with vortioxetine or already participated in the MBRP program
- •Fail to provide informed consent
研究组 & 干预措施
MBRP+vortioxetine intervention
Participants who allocate to the experimental group will receive 8-week 10-20mg/day vortioxetine combined with MBRP intervention.The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists to prevent MA relapse.
10-20mg/day vortioxetine will sent every day and 2-hour MBRP intervention per week until the end of 8-week intervention . They will also receive 10 visits: visit 1 (week 0): medical and psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse rates), assessment of depressive symptoms, improvement in cognition and MA craving.
干预措施: Vortioxetine (Drug)
MBRP intervention
Participants who allocate to the control group will receive 8-week 1-2#/day placebo combined with MBRP intervention.The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists to prevent MA relapse.
1-2#/day placebo will sent every day and 2-hour MBRP intervention per week until the end of 8-week intervention . They will also receive 10 visits: visit 1 (week 0): medical and psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse rates), assessment of depressive symptoms, improvement in cognition and MA craving.
干预措施: Vortioxetine (Drug)
结局指标
主要结局
The Timeline Followback (TLFB) for MA relapse rates
时间窗: 24 weeks
The primary objective is Methamphetamine (MA) relapse rates will be assessed by the Timeline Follow Back (TFB) at weeks 1, 2, 3, 4, 5, 6, 7, 8, and 24. TLFB is a technique for assessing self-reported alcohol or drug consumption that can be used as a clinical and research tool to obtain a variety of quantitative estimates of MA use. This outcome measure integrates data from self-reported supplied in the Time Line Follow Back (a self-reported summary of all substance use over the previous week) with biological verification.
次要结局
- Depressive symptoms will be assessed by Montgomery and Asberg Depression Rating Scale (MADRS, Chinese version)(24 weeks)
- Cognition function will be assessed by THINC-it® cognition screening tool(24 weeks)
研究者
Yanhui Liao
Attending Psychiatrist
Sir Run Run Shaw Hospital