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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03748875
Enrollment
200
Registered
2018-11-21
Start date
2020-05-01
Completion date
2022-12-31
Last updated
2020-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methamphetamine-dependence

Keywords

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

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.

Interventions

mindfulness-based relapse prevention, 8 weeks

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
craving changechange from baseline, 4,8,12,27and 52 weekscraving 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 changebaseline,4,8,12,27and 52 weeksimpulsiveness 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 striatumbaseline, 8 and 12weeksfunctional connectivity between prefrontal cortex and striatum will be measured by fMRI

Secondary

MeasureTime frameDescription
cognitive function improvementbaseline,4,8,12,27and 52 weekscognitive function improvement will be measured by Cogstate system
addiction severity changebaseline,4,8,12,27and 52 weeksaddiction 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
depression level changebaseline,4,8,12,27and 52 weeksdepression 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 changebaseline,4,8,12,27and 52 weeksanxiety 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).

Contacts

Primary ContactJiang DU, Doctor
dujiangdou@163.com021-64906315

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026