Back to resultsMBRP + Vortioxetine VS MBRP on Preventing Relapse in Chronic MA Users
Primary Purpose
Relapse, Cognitive Impairment, Depression
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Vortioxetine
Sponsored by
About this trial
This is an interventional treatment trial for Relapse
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MBRP+vortioxetine intervention
MBRP intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Depressive symptoms will be assessed by Montgomery and Asberg Depression Rating Scale (MADRS, Chinese version)
The efficacy of intervention for depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 2) to Week 24 (Visit 10). MADRS is a 10-item rating scale designed to measure overall severity of the symptoms in depressive and to be sensitive to treatment effects. Symptoms are rated on a 7-point Likert scale from 0 (no symptom) to 6 (severe symptom) with an overall score range from 0 to 60. Participants were considered responsive to vortioxetine if their MADRS score decreased by 50% or more from baseline to the end of treatment，and to be in remission if their final MADRS score is less than 10. A higher score indicates a more severe symptom, and a lower score from the baseline indicates an improvement in symptoms.
Cognition function will be assessed by THINC-it® cognition screening tool
THINC-it® is a sensitive cognitive screening tool for measuring the change of cognitive function and determining whether cognitive function is impaired. It required approximately 10 to 15 minutes for administration. It includes variants of the Choice Reaction Time Identification Task (IDN), One-Back Test, Digit Symbol Substitution Test, Trail Making Test-Part B, and the Perceived Deficits Questionnaire for Depression-5-item (PDQ-5-D).
Full Information
NCT ID
NCT03830827
First Posted
January 14, 2019
Last Updated
November 26, 2019
Sponsor
Sir Run Run Shaw Hospital
Collaborators
Shenzhen Mental Health Center, Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT03830827
Brief Title
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Run Run Shaw Hospital
Collaborators
Shenzhen Mental Health Center, Huazhong University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse, Cognitive Impairment, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MBRP+vortioxetine intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
MBRP intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Other Intervention Name(s)
Mindfulness-based relapse prevention
Intervention Description
8-week 10-20mg/day vortioxetine; 2-hour MBRP intervention per week in 8 weeks
Primary Outcome Measure Information:
Title
The Timeline Followback (TLFB) for MA relapse rates
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Depressive symptoms will be assessed by Montgomery and Asberg Depression Rating Scale (MADRS, Chinese version)
Description
The efficacy of intervention for depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 2) to Week 24 (Visit 10). MADRS is a 10-item rating scale designed to measure overall severity of the symptoms in depressive and to be sensitive to treatment effects. Symptoms are rated on a 7-point Likert scale from 0 (no symptom) to 6 (severe symptom) with an overall score range from 0 to 60. Participants were considered responsive to vortioxetine if their MADRS score decreased by 50% or more from baseline to the end of treatment，and to be in remission if their final MADRS score is less than 10. A higher score indicates a more severe symptom, and a lower score from the baseline indicates an improvement in symptoms.
Time Frame
24 weeks
Title
Cognition function will be assessed by THINC-it® cognition screening tool
Description
THINC-it® is a sensitive cognitive screening tool for measuring the change of cognitive function and determining whether cognitive function is impaired. It required approximately 10 to 15 minutes for administration. It includes variants of the Choice Reaction Time Identification Task (IDN), One-Back Test, Digit Symbol Substitution Test, Trail Making Test-Part B, and the Perceived Deficits Questionnaire for Depression-5-item (PDQ-5-D).
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenzhen Wu, MD
Phone
+8618865477115
Email
zhenzhenjw@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanhui Liao, MD
Organizational Affiliation
Sir Run Run Shaw Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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MBRP + Vortioxetine VS MBRP on Preventing Relapse in Chronic MA Users
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