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

NCT03830827 | Unknown Phase 4 DMC

• 1 other identifier: S2018008
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Relapse; Cognitive Impairment; Depression

Outcome Measures

Primary Outcomes (1)

• The Timeline Followback (TLFB) for MA relapse rates

  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.

  24 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

MBRP+vortioxetine intervention

EXPERIMENTAL

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.

Drug: Vortioxetine

MBRP intervention

EXPERIMENTAL

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.

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

8-week 10-20mg/day vortioxetine; 2-hour MBRP intervention per week in 8 weeks

Also known as: Mindfulness-based relapse prevention

MBRP intervention; MBRP+vortioxetine intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead
• Shenzhen Mental Health Center: collaborator
• Huazhong University of Science and Technology: collaborator

MeSH Terms

Conditions

Recurrence; Cognitive Dysfunction; Depression

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yanhui Liao, MD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenzhen Wu, MD

CONTACT

+8618865477115; zhenzhenjw@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Psychiatrist

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: February 5, 2019
• Study Start: September 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: November 29, 2019

Record last verified: 2019-11