Combination of Psychosocial Intervention and Slow Prosecutions for the Treatment of Methamphetamine Abuse/Dependence
Recruitment status was Not yet recruiting
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Purpose
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
- Psychosocial interventions in combination with slow prosecutions is more effective than psychosocial interventions alone to achieve abstinence for subjects with methamphetamine abuse/dependance.
- Inclusion of telephone reminding before each visit will enhance the retention rate and abstinence rate.
| Condition | Intervention |
|---|---|
|
Amphetamine Abuse Amphetamine Dependence Methamphetamine Abuse Methamphetamine Dependence |
Behavioral: Psychosocial intervention Behavioral: Telephone reminding |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Combination of Psychosocial Intervention and Slow Prosecutions for the Treatment of Methamphetamine Abuse/Dependence |
- Endpoint abstinence rate [ Time Frame: At the end of one-year treatment ] [ Designated as safety issue: No ]According to the urine amphetamine/methamphetamine screen after the one-year treatment, negative result suggests successful abstinence.
- Retention rate [ Time Frame: during the whole one-year treatment ] [ Designated as safety issue: No ]proportion of subjects who can complete the course of one-year treatment
- Length of retention [ Time Frame: during the whole one-year treatment ] [ Designated as safety issue: No ]the averaged duration of attending treatment
- The longest period of abstinence [ Time Frame: during the whole one-year treatment ] [ Designated as safety issue: No ]the longest period of time with successive negative results of urine amphetamine/methamphetamine tests or negative reports of recent methamphetamine use
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: 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 Name: Contingency management
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Yi-Ting Lin, M.D. | +886-5-5323911 ext 7120 | p98421013@ntu.edut.tw |
| Taiwan | |
| National Taiwan University Hospital Yunlin Branch | Not yet recruiting |
| Yunlin, Taiwan | |
| Contact: Yi-Ting Lin, M.D. +886-5-5323911 ext 7120 p98421013@ntu.edu.tw | |
| Principal Investigator: Yi-Ting Lin, M.D. | |
| Sub-Investigator: Li-Ren Chang, M.D. | |
| Principal Investigator: | Yi-Ting Lin, M.D. | Department of Psychiatry, National Taiwan University Hospital Yunlin Branch |
More Information
No publications provided
| Responsible Party: | Yi-Ting, Lin/M.D., Department of Psychiatry, National Taiwan University Hospital Yunlin Branch |
| ClinicalTrials.gov Identifier: | NCT01273701 History of Changes |
| Other Study ID Numbers: | 201011014RB |
| Study First Received: | January 6, 2011 |
| Last Updated: | January 6, 2011 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
amphetamine methamphetamine psychosocial intervention |
contingency management slow prosecution substance use disorder |
Additional relevant MeSH terms:
|
Amphetamine-Related Disorders Substance-Related Disorders Mental Disorders Methamphetamine Amphetamine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013