NCT03748875

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 10, 2020

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

October 7, 2018

Last Update Submit

January 8, 2020

Conditions

Methamphetamine-dependence

Keywords

Mindfulness-based relapse preventionmethamphetaminePrefrontal-striatal circuitimpulsivemechanism

Outcome Measures

Primary Outcomes (3)

  • 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

    change from baseline, 4，8，12，27and 52 weeks

  • 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.

    baseline，4，8，12，27and 52 weeks

  • functional connectivity change between prefrontal cortex and striatum

    functional connectivity between prefrontal cortex and striatum will be measured by fMRI

    baseline, 8 and 12weeks

Secondary Outcomes (4)

  • cognitive function improvement

    baseline，4，8，12，27and 52 weeks

  • depression level change

    baseline，4，8，12，27and 52 weeks

  • anxiety level change

    baseline，4，8，12，27and 52 weeks

  • addiction severity change

    baseline，4，8，12，27and 52 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

an 8-session mindfulness-based relapse prevention program

Behavioral: mindfulness-based relapse prevention

Control group

NO INTERVENTION

treatment as usual

Interventions

mindfulness-based relapse preventionBEHAVIORAL

mindfulness-based relapse prevention, 8 weeks

Intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Impulsive Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Jiang DU, Doctor

CONTACT

021-64906315dujiangdou@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2018

First Posted

November 21, 2018

Study Start

May 1, 2020

Primary Completion

January 1, 2022

Study Completion

December 31, 2022

Last Updated

January 10, 2020

Record last verified: 2019-03