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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04203654
Other study ID # EC1080801
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 24, 2020
Est. completion date December 15, 2020

Study information

Verified date November 2019
Source National Health Research Institutes, Taiwan
Contact Sheng-Chang Wang, Doctor
Phone +886-37-206-166
Email scwang69@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Methamphetamine (MA) use disorder is a serious legal and health problem worldwide. Reports from Ministry of Justice in Taiwan revealed that the MA-related crimes has tremendously increased over the past decade. The arrested users of scheduled II drugs, MA mainly, has surged from 34,886 in 2014 to 54,190 in 2016 in Taiwan. It is critical to tackle the emerging problems in Taiwan.

Management of MA use disorder 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date December 15, 2020
Est. primary completion date July 2, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- Aged 20-65

- Current methamphetamine use disorder by DSM-5, moderate and above

- Willing and able to provide informed consents

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
cognitive-behavior group therapy
cognitive-behavior group therapy Frequency: thrice a week Treatment duration: 16 week
Individual supportive psychotherapy
Individual supportive psychotherapy 3 sessions during the 16-week treatment period

Locations

Country Name City State
Taiwan Taipei City Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urine amphetamine test During Intervention This test looks for amphetamine in urine once a week for 16 weeks. 16 weeks
Primary Urine amphetamine test,Follow-Up This test looks for amphetamine in urine once a month for 3 months. 3 months
Secondary The World Health Organization Quality of Life -BREF (WHOQOL-BREF) During Intervention The content of the questionnaire is divided into four domains. The converted scores of each participant's answers are as low as 4 points and as high as 20 points in each category,a higher score means better quality of life. 16 weeks
Secondary The World Health Organization Quality of Life -BREF (WHOQOL-BREF),Follow-Up The content of the questionnaire is divided into four domains. The converted scores of each participant's answers are as low as 4 points and as high as 20 points in each category,a higher score means better quality of life. 3 months
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