Trial record 2 of 30 for:    Open Studies | "Methamphetamine"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by National Taiwan University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01273701
First received: January 6, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  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

  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.

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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273701

Contacts
Contact: Yi-Ting Lin, M.D. +886-5-5323911 ext 7120 p98421013@ntu.edut.tw

Locations
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.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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
Chemically-Induced Disorders
Mental Disorders
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014