Implementation and Effectiveness of Multidiscipline-Integrated Addiction Treatment Model

Amphetamine-Related Disorders Clinical Trial

Official title:

Implementation and Effectiveness of Multidiscipline-Integrated Addiction Treatment Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04203654
• Other study ID #: EC1080801
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Amphetamine-Related Disorders

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