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

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

1. Psychosocial interventions in combination with slow prosecutions is more effective than psychosocial interventions alone to achieve abstinence for subjects with methamphetamine abuse/dependance.
2. Inclusion of telephone reminding before each visit will enhance the retention rate and abstinence rate.

Study Overview

• Status: Unknown
• Conditions: Methamphetamine Dependence; Methamphetamine Abuse; Amphetamine Dependence; Amphetamine Abuse
• Intervention / Treatment: Behavioral: Psychosocial intervention; Behavioral: Telephone reminding

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi-Ting Lin, M.D.; Phone Number: 7120 +886-5-5323911; Email: p98421013@ntu.edut.tw

Study Locations

• Taiwan
  • Yunlin, Taiwan
    • National Taiwan University Hospital Yunlin Branch
    • Contact: Yi-Ting Lin, M.D.; Phone Number: 7120 +886-5-5323911; Email: p98421013@ntu.edu.tw
    • Principal Investigator: Yi-Ting Lin, M.D.
    • Sub-Investigator: Li-Ren Chang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TSTSU-N; 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.	Behavioral: Psychosocial intervention; 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.; Other Names: Contingency management
EXPERIMENTAL: TSTSU-T; 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.	Behavioral: Psychosocial intervention; 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.; Other Names: Contingency management; Behavioral: Telephone reminding; 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.
ACTIVE_COMPARATOR: OPD; 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.	Behavioral: Psychosocial intervention; 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.; Other Names: Contingency management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endpoint abstinence rate	According to the urine amphetamine/methamphetamine screen after the one-year treatment, negative result suggests successful abstinence.	At the end of one-year treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention rate	proportion of subjects who can complete the course of one-year treatment	during the whole one-year treatment
Length of retention	the averaged duration of attending treatment	during the whole one-year 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	during the whole one-year treatment

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yi-Ting Lin, M.D., Department of Psychiatry, National Taiwan University Hospital Yunlin Branch

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: January 6, 2011
• First Submitted That Met QC Criteria: January 6, 2011
• First Posted (ESTIMATE): January 10, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2011
• Last Update Submitted That Met QC Criteria: January 6, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: psychosocial intervention; amphetamine; methamphetamine; substance use disorder; contingency management; slow prosecution
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Amphetamine-Related Disorders
• Other Study ID Numbers: 201011014RB