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

• ClinicalTrials.gov Identifier: NCT03748875
• Recruitment Status: Unknown
• First Posted: November 21, 2018
• Last Update Posted: January 10, 2020
• Sponsor: Shanghai Mental Health Center
• Information provided by (Responsible Party): Shanghai Mental Health Center

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.

Condition or disease	Intervention/treatment	Phase
Methamphetamine-dependence	Behavioral: mindfulness-based relapse prevention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Mindfulness-based Relapse Prevention on Impulsive Control Circuit Among Methamphetamine Dependents
• Estimated Study Start Date: May 1, 2020
• Estimated Primary Completion Date: January 1, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention group; an 8-session mindfulness-based relapse prevention program	Behavioral: mindfulness-based relapse prevention; mindfulness-based relapse prevention, 8 weeks
No Intervention: Control group; treatment as usual

Outcome Measures

Primary Outcome Measures :

1. craving change [ Time Frame: change from baseline, 4，8，12，27and 52 weeks ]
   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
2. impulsiveness change [ Time Frame: baseline，4，8，12，27and 52 weeks ]
   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.
3. functional connectivity change between prefrontal cortex and striatum [ Time Frame: baseline, 8 and 12weeks ]
   functional connectivity between prefrontal cortex and striatum will be measured by fMRI

Secondary Outcome Measures :

1. cognitive function improvement [ Time Frame: baseline，4，8，12，27and 52 weeks ]
   cognitive function improvement will be measured by Cogstate system
2. depression level change [ Time Frame: baseline，4，8，12，27and 52 weeks ]
   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.
3. anxiety level change [ Time Frame: baseline，4，8，12，27and 52 weeks ]
   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).
4. addiction severity change [ Time Frame: baseline，4，8，12，27and 52 weeks ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Contacts

Contact: Jiang DU, Doctor; 021-64906315; dujiangdou@163.com

Sponsors and Collaborators

Shanghai Mental Health Center

More Information

• Responsible Party: Shanghai Mental Health Center
• ClinicalTrials.gov Identifier: NCT03748875
• Other Study ID Numbers: JDu-006
• First Posted: November 21, 2018
• Last Update Posted: January 10, 2020
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

Keywords provided by Shanghai Mental Health Center:

Mindfulness-based relapse prevention; methamphetamine; Prefrontal-striatal circuit; impulsive; mechanism

Additional relevant MeSH terms:

Recurrence; Impulsive Behavior; Disease Attributes; Pathologic Processes