- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04203654
Implementation and Effectiveness of Multidiscipline-Integrated Addiction Treatment Model
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sheng-Chang Wang, Doctor
- Phone Number: 36703 +886-37-206-166
- Email: scwang69@gmail.com
Study Locations
-
-
-
Taipei, Taiwan, 10341
- Recruiting
- Taipei City Hospital
-
Contact:
- Sheng-Chang Wang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cognitive-behavior group therapy group
|
cognitive-behavior group therapy Frequency: thrice a week Treatment duration: 16 week
Individual supportive psychotherapy 3 sessions during the 16-week treatment period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urine amphetamine test During Intervention
Time Frame: 16 weeks
|
This test looks for amphetamine in urine once a week for 16 weeks.
|
16 weeks
|
Urine amphetamine test,Follow-Up
Time Frame: 3 months
|
This test looks for amphetamine in urine once a month for 3 months.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The World Health Organization Quality of Life -BREF (WHOQOL-BREF) During Intervention
Time Frame: 16 weeks
|
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
|
The World Health Organization Quality of Life -BREF (WHOQOL-BREF),Follow-Up
Time Frame: 3 months
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC1080801
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amphetamine-Related Disorders
-
National Taiwan University HospitalUnknownMethamphetamine Dependence | Methamphetamine Abuse | Amphetamine Dependence | Amphetamine AbuseTaiwan
-
Friends Research Institute, Inc.National Institute on Drug Abuse (NIDA)Completed
-
University of PennsylvaniaNational Institute on Drug Abuse (NIDA); Society of Alcoholism and other AddictionsCompletedAmphetamine DependenceIceland
-
Shanghai Mental Health CenterCompletedAmphetamine AddictionChina
-
Shanghai Mental Health CenterRecruitingAmphetamine AddictionChina
-
Centre hospitalier de l'Université de Montréal...Withdrawn
-
Shanghai Mental Health CenterCompleted
-
University of VirginiaAmerican Association of Chairs of Departments of PsychiatryWithdrawnAmphetamine DependenceUnited States
-
The University of New South WalesSt Vincent's Hospital, Sydney; Australian Government Department of Health and... and other collaboratorsUnknown
-
California Pacific Medical Center Research InstituteUnknownSubstance Dependence | Amphetamine DependenceUnited States
Clinical Trials on cognitive-behavior group therapy
-
Stockholm UniversityKarolinska InstitutetCompleted
-
VA Office of Research and DevelopmentIndiana University School of MedicineCompleted
-
Wuhan Mental Health CentreNot yet recruitingDepression and Anxiety Symptom
-
St. Olavs HospitalNorwegian University of Science and TechnologyCompletedAttention Deficit Disorder With HyperactivityNorway
-
Laval UniversityUniversity of California, BerkeleyCompleted
-
Hopital MontfortUniversity of Ottawa; Ontario Mental Health FoundationCompletedSocial Anxiety DisorderCanada
-
Karolinska InstitutetRegion StockholmCompletedPanic DisorderSweden
-
University of North Carolina, CharlotteOhio State University; United States Naval Medical Center, PortsmouthRecruitingDepression | PTSD | Anxiety | Suicidal Ideation | Suicide, Attempted | Coping SkillsUnited States
-
National Institute of Neurological Disorders and...Completed
-
Karolinska InstitutetCompletedIrritable Bowel Syndrome