NCT04203654

Brief Summary

Management of substance use disorders in clinical settings is challenging. Approaches with integrated bio-psycho-social interventions, along with the engagement of families and self-help groups are strongly recommended. The Matrix intensive outpatient program has been developed in UCLA to help the psychostimulant misusers in the Southern California in 1980's. With integration of the existing evidence of addiction researches and empirically supported cognitive-behavior treatment techniques, the Matrix model developed manuals to address knowledge and skills needed for drug users in their early recovery and relapse prevention. The treatment was delivered in a 16-week intensive structured group sessions. There was also a 12-week educational sessions for the in-treatment individuals and their families. A substantial body of evidence has demonstrated the successful experience of the Matrix treatment model in management a broad spectrum of addictive disorders in many countries. The objectives of the pilot project are to set up a multi-center collaborative clinical network with implementation of an integrated addiction treatment program modified from the UCLA Matrix model. Via the establishment of standardized subject recruitment criteria, treatment and outcome assessment procedures, the study aims to assess the adherence of participating clinical organizations to the study protocol, the acceptance of participating MA misusers for the integrated treatment program as well as the outcomes and their determinants for the treatment models.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

December 12, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 24, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

April 1, 2020

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

December 12, 2019

Last Update Submit

March 30, 2020

Conditions

Amphetamine-Related Disorders

Keywords

MethamphetamineCognitive behavior group therapy

Outcome Measures

Primary Outcomes (2)

  • Urine amphetamine test During Intervention

    This test looks for amphetamine in urine once a week for 16 weeks.

    16 weeks

  • Urine amphetamine test,Follow-Up

    This test looks for amphetamine in urine once a month for 3 months.

    3 months

Secondary Outcomes (2)

  • The World Health Organization Quality of Life -BREF (WHOQOL-BREF) During Intervention

    16 weeks

  • The World Health Organization Quality of Life -BREF (WHOQOL-BREF),Follow-Up

    3 months

Study Arms (1)

Cognitive-behavior group therapy group

OTHER
Behavioral: cognitive-behavior group therapyBehavioral: Individual supportive psychotherapy

Interventions

cognitive-behavior group therapyBEHAVIORAL

cognitive-behavior group therapy Frequency: thrice a week Treatment duration: 16 week

Cognitive-behavior group therapy group
Individual supportive psychotherapyBEHAVIORAL

Individual supportive psychotherapy 3 sessions during the 16-week treatment period

Cognitive-behavior group therapy group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 20-65
  • Current methamphetamine use disorder by DSM-5, moderate and above
  • Willing and able to provide informed consents

You may not qualify if:

  • Severe physical or psychiatric conditions requiring emergent treatment
  • Currently involved in judicial or criminal conditions
  • Plan to go abroad or relocate in the next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, 10341, Taiwan

RECRUITING

MeSH Terms

Conditions

Amphetamine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Sheng-Chang Wang, Doctor

CONTACT

+886-37-206-166scwang69@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 18, 2019

Study Start

February 24, 2020

Primary Completion

July 2, 2020

Study Completion

December 15, 2020

Last Updated

April 1, 2020

Record last verified: 2019-11

Locations

TW(1)