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Combination of Psychosocial Intervention and Slow Prosecutions for the Treatment of Methamphetamine Abuse/Dependence

Primary Purpose

Amphetamine Abuse, Amphetamine Dependence, Methamphetamine Abuse

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Psychosocial intervention
Telephone reminding
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amphetamine Abuse focused on measuring amphetamine, methamphetamine, psychosocial intervention, contingency management, slow prosecution, substance use disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • DSM-IV-TR criteria for amphetamine/methamphetamine abuse or dependence
  • 18 - 65 years old
  • For TSTSU-N and TSTSU-T arms: methamphetamine offenders referred by the Yunlin District Prosecutors Office
  • For OPD arm: psychiatric outpatients referred from the psychiatry clinics in National Taiwan University Hospital, Yunlin Branch

Exclusion Criteria:

  • Concurrent use of other illicit substances
  • Co-morbidity with major psychotic disorders (schizophrenia, schizoaffective disorder, other psychotic disorder), mental retardation, acute episodes of major depressive disorder or bipolar affective disorder) or serious personality disorders.

Sites / Locations

  • National Taiwan University Hospital Yunlin Branch

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

TSTSU-N

TSTSU-T

OPD

Arm Description

TSTSU-N stands for Treatment for Schedule Two Substance Use, No Telephone Reminding. Subjects will be referred by the Yunlin District Prosecutors Office for one-year psychosocial interventions to get slow prosecutions. After the referral, they will be randomized in a 1:1 ratio to either TSTSU-N group or TSTSU-T group. During the intervention, subjects of TSTSU-N will not receive telephone reminding before each visit.

TSTSU-T stands for Treatment for Schedule Two Substance Use, Telephone Reminding. Subjects will be referred by the Yunlin District Prosecutors Office for one-year psychosocial interventions to get slow prosecutions. After the referral, they will be randomized in a 1:1 ratio to either TSTSU-N group or TSTSU-T group. During the intervention, subjects of TSTSU-T will receive telephone reminding before each visit.

OPD stands for Outpatient Department. Subjects in this arm will be methamphetamine users who voluntarily visit psychiatric clinics for treatment of mental disorders in National Taiwan University Hospital, Yunlin Branch. They will be referred to this study by their treating psychiatrists.

Outcomes

Primary Outcome Measures

Endpoint abstinence rate
According to the urine amphetamine/methamphetamine screen after the one-year treatment, negative result suggests successful abstinence.

Secondary Outcome Measures

Retention rate
proportion of subjects who can complete the course of one-year treatment
Length of retention
the averaged duration of attending treatment
The longest period of abstinence
the longest period of time with successive negative results of urine amphetamine/methamphetamine tests or negative reports of recent methamphetamine use

Full Information

First Posted
January 6, 2011
Last Updated
January 6, 2011
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01273701
Brief Title
Combination of Psychosocial Intervention and Slow Prosecutions for the Treatment of Methamphetamine Abuse/Dependence
Official Title
Combination of Psychosocial Intervention and Slow Prosecutions for the Treatment of Methamphetamine Abuse/Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The hospital where this study will be conducted is responsible for the one-year contingency management treatment for methamphetamine drug offenders referred from the Yunlin District Prosecutors Office. Completing the one-year treatment is prerequisite for offenders to get slow prosecutions. It is an open-label, parallel-group trial comparing the combination of psychosocial intervention and slow prosecutions with psychosocial intervention alone in treating subjects with methamphetamine dependence Study Hypothesis Psychosocial interventions in combination with slow prosecutions is more effective than psychosocial interventions alone to achieve abstinence for subjects with methamphetamine abuse/dependance. Inclusion of telephone reminding before each visit will enhance the retention rate and abstinence rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine Abuse, Amphetamine Dependence, Methamphetamine Abuse, Methamphetamine Dependence
Keywords
amphetamine, methamphetamine, psychosocial intervention, contingency management, slow prosecution, substance use disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TSTSU-N
Arm Type
Experimental
Arm Description
TSTSU-N stands for Treatment for Schedule Two Substance Use, No Telephone Reminding. Subjects will be referred by the Yunlin District Prosecutors Office for one-year psychosocial interventions to get slow prosecutions. After the referral, they will be randomized in a 1:1 ratio to either TSTSU-N group or TSTSU-T group. During the intervention, subjects of TSTSU-N will not receive telephone reminding before each visit.
Arm Title
TSTSU-T
Arm Type
Experimental
Arm Description
TSTSU-T stands for Treatment for Schedule Two Substance Use, Telephone Reminding. Subjects will be referred by the Yunlin District Prosecutors Office for one-year psychosocial interventions to get slow prosecutions. After the referral, they will be randomized in a 1:1 ratio to either TSTSU-N group or TSTSU-T group. During the intervention, subjects of TSTSU-T will receive telephone reminding before each visit.
Arm Title
OPD
Arm Type
Active Comparator
Arm Description
OPD stands for Outpatient Department. Subjects in this arm will be methamphetamine users who voluntarily visit psychiatric clinics for treatment of mental disorders in National Taiwan University Hospital, Yunlin Branch. They will be referred to this study by their treating psychiatrists.
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial intervention
Other Intervention Name(s)
Contingency management
Intervention Description
The treatment is one-year long and composed of 3 stages of psychosocial intervention. Subjects of TSTSU arms receive urine methamphetamine examinations at each visit, while subjects in OPD arm being tested at first/last visits and during stage changes. -Stage 1, early intensive monitoring stage: The visit interval is 1 week. If the urine tests and self-report on methamphetamine use are negative for consecutive 4 visits, subjects can proceed to stage 2. (In OPD arm, the visit interval can be 2 weeks according to subjects' requirements.) -Sage 2, late intensive monitoring stage: The visit interval is 2 week. If the urine tests and self-reports are straightly negative for 4 visits, subjects can proceed to stage 3. Whenever recent methamphetamine is detected, subjects should move back to stage 1. -Stage 3, usual monitoring stage: The visit interval is 1 month until the end of treatment. Whenever recent methamphetamine is detected, subjects should move back to stage 1.
Intervention Type
Behavioral
Intervention Name(s)
Telephone reminding
Intervention Description
Subjects in TSTSU-T group will receive addition telephone reminding one day before each visit. Each call will be no longer than five minutes. On the telephone, brief motivation enhancement may be conducted.
Primary Outcome Measure Information:
Title
Endpoint abstinence rate
Description
According to the urine amphetamine/methamphetamine screen after the one-year treatment, negative result suggests successful abstinence.
Time Frame
At the end of one-year treatment
Secondary Outcome Measure Information:
Title
Retention rate
Description
proportion of subjects who can complete the course of one-year treatment
Time Frame
during the whole one-year treatment
Title
Length of retention
Description
the averaged duration of attending treatment
Time Frame
during the whole one-year treatment
Title
The longest period of abstinence
Description
the longest period of time with successive negative results of urine amphetamine/methamphetamine tests or negative reports of recent methamphetamine use
Time Frame
during the whole one-year treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV-TR criteria for amphetamine/methamphetamine abuse or dependence 18 - 65 years old For TSTSU-N and TSTSU-T arms: methamphetamine offenders referred by the Yunlin District Prosecutors Office For OPD arm: psychiatric outpatients referred from the psychiatry clinics in National Taiwan University Hospital, Yunlin Branch Exclusion Criteria: Concurrent use of other illicit substances Co-morbidity with major psychotic disorders (schizophrenia, schizoaffective disorder, other psychotic disorder), mental retardation, acute episodes of major depressive disorder or bipolar affective disorder) or serious personality disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Ting Lin, M.D.
Phone
+886-5-5323911
Ext
7120
Email
p98421013@ntu.edut.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Ting Lin, M.D.
Organizational Affiliation
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital Yunlin Branch
City
Yunlin
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Ting Lin, M.D.
Phone
+886-5-5323911
Ext
7120
Email
p98421013@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Yi-Ting Lin, M.D.
First Name & Middle Initial & Last Name & Degree
Li-Ren Chang, M.D.

12. IPD Sharing Statement

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Combination of Psychosocial Intervention and Slow Prosecutions for the Treatment of Methamphetamine Abuse/Dependence

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