Clinical trial NCT03748875: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Methamphetamine-dependence
Keywords: Mindfulness-based relapse prevention
methamphetamine
Prefrontal-striatal circuit
impulsive
mechanism
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: craving change
timeFrame: change from baseline, 4，8，12，27and 52 weeks
measure: impulsiveness change
timeFrame: baseline，4，8，12，27and 52 weeks
measure: functional connectivity change between prefrontal cortex and striatum
timeFrame: baseline, 8 and 12weeks
Secondary outcomes:
measure: cognitive function improvement
timeFrame: baseline，4，8，12，27and 52 weeks
measure: depression level change
timeFrame: baseline，4，8，12，27and 52 weeks
measure: anxiety level change
timeFrame: baseline，4，8，12，27and 52 weeks
measure: addiction severity change
timeFrame: baseline，4，8，12，27and 52 weeks
Other outcomes:
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