NCT03830827

MBRP + Vortioxetine VS MBRP on Preventing Relapse in Chronic MA Users

Efficacy of Mindfulness-based Relapse Prevention With or Without Vortioxetine on the Prevention of Relapse in Chronic Methamphetamine Users

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Relapse
• Cognitive Impairment
• Depression

Interventions

Type	Name	Description
DRUG	Vortioxetine	8-week 10-20mg/day vortioxetine; 2-hour MBRP intervention per week in 8 weeks

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2019-02-05
• Last updated: 2019-11-29