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

NCT01273701 | Unknown

• 1 other identifier: 201011014RB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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

Keywords

amphetamine; methamphetamine; psychosocial intervention; contingency management; slow prosecution; substance use disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Retention rate

  during the whole one-year treatment

• Length of retention

  during the whole one-year treatment

• The longest period of abstinence

  during the whole one-year treatment

Study Arms (3)

TSTSU-N

EXPERIMENTAL

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

TSTSU-T

EXPERIMENTAL

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; Behavioral: Telephone reminding

OPD

ACTIVE COMPARATOR

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

Interventions

Psychosocial intervention 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.

Also known as: Contingency management

OPD; TSTSU-N; TSTSU-T

Telephone reminding 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.

TSTSU-T

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-IV-TR criteria for amphetamine/methamphetamine abuse or dependence
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Yunlin Branch

Yunlin, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Amphetamine-Related Disorders; Substance-Related Disorders

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Yi-Ting Lin, M.D.

  Department of Psychiatry, National Taiwan University Hospital Yunlin Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Ting Lin, M.D.

CONTACT

+886-5-5323911; p98421013@ntu.edut.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 10, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 10, 2011

Record last verified: 2010-12

Locations

TW (1)