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

NCT ID: NCT01273701

Last Updated: 2011-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

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

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.

Conditions

Amphetamine Abuse; Amphetamine Dependence; Methamphetamine Abuse; Methamphetamine Dependence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Psychosocial intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Psychosocial intervention

Intervention Type: BEHAVIORAL

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.

Telephone reminding

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Psychosocial intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Contingency management

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Department of Psychiatry, National Taiwan University Hospital Yunlin Branch

Principal Investigators

Yi-Ting Lin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, National Taiwan University Hospital Yunlin Branch

Locations

National Taiwan University Hospital Yunlin Branch

Yunlin, Taiwan, Taiwan

Countries

Taiwan

Central Contacts

Yi-Ting Lin, M.D.

Role: CONTACT

p98421013@ntu.edut.tw

+886-5-5323911 ext. 7120

Facility Contacts

Yi-Ting Lin, M.D.

Role: primary

p98421013@ntu.edu.tw

+886-5-5323911 ext. 7120

Other Identifiers

201011014RB

Identifier Type: -

Identifier Source: org_study_id