search
Back to results

The Effect of Mindfulness-based Relapse Prevention on Impulsive Control Circuit Among Methamphetamine Dependents

Primary Purpose

Methamphetamine-dependence

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mindfulness-based relapse prevention
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Methamphetamine-dependence focused on measuring Mindfulness-based relapse prevention, methamphetamine, Prefrontal-striatal circuit, impulsive, mechanism

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-45 years old, male or female, with 9 years of education or above, can cooperate with the completion of the questionnaire evaluation;
  • Comply with DSM-V diagnostic criteria for amphetamine-based addiction;
  • The previous use of amphetamines for not less than 1 year (at least once a week);
  • Vision and hearing are normal, or in the normal range after correction. No contraindications for magnetic resonance imaging;
  • agree to cooperate with the completion of follow-up evaluation;
  • The Mindfulness Attention Awareness Scale score is greater than 50 points.

Exclusion Criteria:

  • Severe cognitive dysfunction, such as history of head trauma, cerebrovascular disease, epilepsy, etc., drugs used to promote cognitive function in the last 6 months; intellectual impairment IQ<70;
  • There have been other abuse or dependence of psychoactive substances in the past 5 years (excluding nicotine); 100 healthy controls have been publicly collected by the public. Exclude serious physical illness and mental damage. through
  • SCID clinical interviews exclude family history of mental disorders and psychosis, no history of substance abuse (except nicotine).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    an 8-session mindfulness-based relapse prevention program

    treatment as usual

    Outcomes

    Primary Outcome Measures

    craving change
    craving will be measured by visual analogue scale(VAS), participants specify their level of craving by indicating a position along a continuous line between two end-points, score ranges from 0 to 10, 0 refers to the lowest level of craving, 10 refers to the highest level of craving
    impulsiveness change
    impulsiveness will be measured by Barratt Impulsiveness Scale, the scale is a 30 item self-report measure, Rarely/Never = 1，Occasionally = 2，Often = 3，Almost Always/Always = 4. Assessment is indicated by the total score added together.
    functional connectivity change between prefrontal cortex and striatum
    functional connectivity between prefrontal cortex and striatum will be measured by fMRI

    Secondary Outcome Measures

    cognitive function improvement
    cognitive function improvement will be measured by Cogstate system
    depression level change
    depression level will be measured by patient health questionnaire-9(PHQ-9). The Patient Health Questionnaire (PHQ) is a multiple-choice self-report inventory, and The PHQ-9 is a tool specific to depression which has 9 items. Assessment is indicated by the total score, which made up by adding together the scores for the scale all seven items.System of scoring is Not at all (0 points),Several days (1 point) More than half the days (2 points) and Nearly every day (3 points).PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
    anxiety level change
    anxiety level will be measured by Generalized Anxiety Disorder(GAD-7). it has 7 items and measure severity of various signs of GAD according to reported response categories with assigned points. Assessment is indicated by the total score, which made up by adding together the scores for the scale all seven items.System of scoring is Not at all (0 points),Several days (1 point) More than half the days (2 points) and Nearly every day (3 points).
    addiction severity change
    addiction severity will be measured by addiction severity index(ASI). ASI is a semi-structured instrument used in face-to-face interviews conducted by clinicians, researchers or trained techniciansIt measures Medical issues relating to drug use, Employment/Support Status, Levels of Alcohol and Drug Use, Legal Issues Arising from Substance Abuse, Family/Social Factors and Psychiatric/Mental Health Status. Severity ratings are based on the following 10 point scale (0-9).0-1: No real problem, treatment not indicated, 2-3: Slight problem, treatment probably not necessary 4-5: Moderate problem, some treatment indicated 6-7: Considerable problem, treatment necessary 8-9: Extreme problem, treatment absolutely necessary

    Full Information

    First Posted
    October 7, 2018
    Last Updated
    January 8, 2020
    Sponsor
    Shanghai Mental Health Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03748875
    Brief Title
    The Effect of Mindfulness-based Relapse Prevention on Impulsive Control Circuit Among Methamphetamine Dependents
    Official Title
    The Effect of Mindfulness-based Relapse Prevention on Impulsive Control Circuit Among Methamphetamine Dependents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2020 (Anticipated)
    Primary Completion Date
    January 1, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Mental Health Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Amphetamine-type stimulants (ATSs) have become the most important medical issue as well as the social problem. Compared with traditional drugs, ATS are highly neurotoxin and can induce cognitive deficit and psychotic symptoms. Due to lack of efficient medical treatment, psychotherapy and behavioral interventions are the main treatment strategies so far. Mindful-based relapse prevention (MBRP) which combined mindfulness with relapse prevention skills, as a novel intervention, has been widely used in prevent craving and relapse among addictions. While the current research of MBRP mechanism focus on emotion regulation circuit, and there was no study to explore the impulsive circuit, which is the important factor that induce the addiction and relapse. However, there was no report about the influence of MBRP on Prefrontal-striatal circuits. Based on the previous results, the proposed study will focus on evaluating the mechanism of MBRP on prefrontal-striatal circuits, neuropsychological tests and functional MRI will be used to investigate the neurobiological mechanism of MBRP on prefrontal-striatal circuits and related impulsive behaviors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Methamphetamine-dependence
    Keywords
    Mindfulness-based relapse prevention, methamphetamine, Prefrontal-striatal circuit, impulsive, mechanism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    an 8-session mindfulness-based relapse prevention program
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    treatment as usual
    Intervention Type
    Behavioral
    Intervention Name(s)
    mindfulness-based relapse prevention
    Intervention Description
    mindfulness-based relapse prevention, 8 weeks
    Primary Outcome Measure Information:
    Title
    craving change
    Description
    craving will be measured by visual analogue scale(VAS), participants specify their level of craving by indicating a position along a continuous line between two end-points, score ranges from 0 to 10, 0 refers to the lowest level of craving, 10 refers to the highest level of craving
    Time Frame
    change from baseline, 4，8，12，27and 52 weeks
    Title
    impulsiveness change
    Description
    impulsiveness will be measured by Barratt Impulsiveness Scale, the scale is a 30 item self-report measure, Rarely/Never = 1，Occasionally = 2，Often = 3，Almost Always/Always = 4. Assessment is indicated by the total score added together.
    Time Frame
    baseline，4，8，12，27and 52 weeks
    Title
    functional connectivity change between prefrontal cortex and striatum
    Description
    functional connectivity between prefrontal cortex and striatum will be measured by fMRI
    Time Frame
    baseline, 8 and 12weeks
    Secondary Outcome Measure Information:
    Title
    cognitive function improvement
    Description
    cognitive function improvement will be measured by Cogstate system
    Time Frame
    baseline，4，8，12，27and 52 weeks
    Title
    depression level change
    Description
    depression level will be measured by patient health questionnaire-9(PHQ-9). The Patient Health Questionnaire (PHQ) is a multiple-choice self-report inventory, and The PHQ-9 is a tool specific to depression which has 9 items. Assessment is indicated by the total score, which made up by adding together the scores for the scale all seven items.System of scoring is Not at all (0 points),Several days (1 point) More than half the days (2 points) and Nearly every day (3 points).PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
    Time Frame
    baseline，4，8，12，27and 52 weeks
    Title
    anxiety level change
    Description
    anxiety level will be measured by Generalized Anxiety Disorder(GAD-7). it has 7 items and measure severity of various signs of GAD according to reported response categories with assigned points. Assessment is indicated by the total score, which made up by adding together the scores for the scale all seven items.System of scoring is Not at all (0 points),Several days (1 point) More than half the days (2 points) and Nearly every day (3 points).
    Time Frame
    baseline，4，8，12，27and 52 weeks
    Title
    addiction severity change
    Description
    addiction severity will be measured by addiction severity index(ASI). ASI is a semi-structured instrument used in face-to-face interviews conducted by clinicians, researchers or trained techniciansIt measures Medical issues relating to drug use, Employment/Support Status, Levels of Alcohol and Drug Use, Legal Issues Arising from Substance Abuse, Family/Social Factors and Psychiatric/Mental Health Status. Severity ratings are based on the following 10 point scale (0-9).0-1: No real problem, treatment not indicated, 2-3: Slight problem, treatment probably not necessary 4-5: Moderate problem, some treatment indicated 6-7: Considerable problem, treatment necessary 8-9: Extreme problem, treatment absolutely necessary
    Time Frame
    baseline，4，8，12，27and 52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18-45 years old, male or female, with 9 years of education or above, can cooperate with the completion of the questionnaire evaluation; Comply with DSM-V diagnostic criteria for amphetamine-based addiction; The previous use of amphetamines for not less than 1 year (at least once a week); Vision and hearing are normal, or in the normal range after correction. No contraindications for magnetic resonance imaging; agree to cooperate with the completion of follow-up evaluation; The Mindfulness Attention Awareness Scale score is greater than 50 points. Exclusion Criteria: Severe cognitive dysfunction, such as history of head trauma, cerebrovascular disease, epilepsy, etc., drugs used to promote cognitive function in the last 6 months; intellectual impairment IQ<70; There have been other abuse or dependence of psychoactive substances in the past 5 years (excluding nicotine); 100 healthy controls have been publicly collected by the public. Exclude serious physical illness and mental damage. through SCID clinical interviews exclude family history of mental disorders and psychosis, no history of substance abuse (except nicotine).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jiang DU, Doctor
    Phone
    021-64906315
    Email
    dujiangdou@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    The Effect of Mindfulness-based Relapse Prevention on Impulsive Control Circuit Among Methamphetamine Dependents

    We'll reach out to this number within 24 hrs