Clinical trial NCT03830827: MBRP + Vortioxetine VS MBRP on Preventing Relapse in Chronic MA Users
Official title: Efficacy of Mindfulness-based Relapse Prevention With or Without Vortioxetine on the Prevention of Relapse in Chronic Methamphetamine Users
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Relapse
Cognitive Impairment
Depression
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen Mental Health Center
name: Huazhong University of Science and Technology
First posted: 2019-02-05
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. DSM-V diagnosis of MA dependence within the last year
2. completion or scheduled completion (i.e., within 2 weeks) of inpatient or intensive outpatient treatment for MA dependence.
3. express a wish to remain abstinent from MA use
4. be age 18 to 65
5. 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
6. willingness to randomization and attendance at treatment and assessment sessions
7. be able to attend all clinic visits without interruption
8. score greater than 16 on the HAM D17 and MADRS \>= 26, as well as currently not on any psychotropics for treatment of depression

Exclusion Criteria:

1. 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.
2. Serious medical comorbidity requiring medical intervention or close supervision, including pacemakers, heart transplant, severe arrhythmias, or active atrial fibrillation, gross neurological disease
3. Suicide attempt in the last 3 months
4. Pregnant or breastfeeding women
5. Prior treatment with vortioxetine or already participated in the MBRP program
6. Fail to provide informed consent

Primary outcomes:
measure: The Timeline Followback (TLFB) for MA relapse rates
timeFrame: 24 weeks
Secondary outcomes:
measure: Depressive symptoms will be assessed by Montgomery and Asberg Depression Rating Scale (MADRS, Chinese version)
timeFrame: 24 weeks
measure: Cognition function will be assessed by THINC-it® cognition screening tool
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Yanhui Liao, MD
role: PRINCIPAL_INVESTIGATOR
References: