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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01273701
Other study ID # 201011014RB
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 6, 2011
Last updated January 6, 2011
Start date January 2011
Est. completion date December 2012

Study information

Verified date December 2010
Source National Taiwan University Hospital
Contact Yi-Ting Lin, M.D.
Phone +886-5-5323911
Email p98421013@ntu.edut.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.
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.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Yunlin Branch Yunlin

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Retention rate proportion of subjects who can complete the course of one-year treatment during the whole one-year treatment No
Secondary Length of retention the averaged duration of attending treatment during the whole one-year treatment No
Secondary 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 No
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