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

Methamphetamine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01273701
• Other study ID #: 201011014RB
• 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

Related Conditions & MeSH terms

• Amphetamine Abuse
• Amphetamine Dependence
• Amphetamine-Related Disorders
• Methamphetamine Abuse
• Methamphetamine Dependence

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