An Study of Paliperidone Extended-Release Tablets in the Treatment of Methamphetamine Dependence
Study Details
Study Description
Brief Summary
Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for methamphetamine dependence exist. paliperidone are Second generation antipsychotics，and have effects of blocking dopamine2(D2) and 5-hydroxytryptamine 2A(5-HT) receptors neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among methamphetamine addicts.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Methods:A Multiple-Center, Randomized, Double-Blind.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: paliperidone paliperidone arm,3mg/pill,3mg/day.last84 days. |
Drug: Paliperidone
Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days
Other Names:
|
| Placebo Comparator: placebo placebo group,3mg/pill,3mg/day non-forced titration method,last84 days. |
Drug: placebo
placebo group,3mg/pill,3mg/day forced titration method,last 84 days
|
Outcome Measures
Primary Outcome Measures
- Abstinent time of Methamphetamine addict [up to 84 days]
The outcome was the confirmed abstinence during 12 weeks. Confirmed abstinence was defined as a negative urine drug test. The following aggregate measures of urine drug test results were calculated: the time-to-first positive urine test, the Treatment Effectiveness Score (TES; the sum of the number of METH-free urine samples submitted per participant ), the longest period of MA abstinence during the 84 days.
Secondary Outcome Measures
- Time (day) to first psychosis relapse from baseline to 84 days [up to 84 days]
psychosis assessement was made once a week.Psychotic symptom relapse was defined as one or more of the following: (1) hospitalization for psychotic symptoms; deliberate self-injury or violent behavior, or suicidal or homicidal ideation that was clinically significant;25% increase in PANSS total score;for patients who scored >40 at randomization, or a 10-point increase for patients who scored ≤40 at randomization for two consecutive assessments (within 1 week), and (4) increase in prespecified individual PANSS items scores (P1, P2, P3, P6, P7 and G8) to ≥5 for patients whose score was ≤3 at randomization, or to ≥6 for patients whose score was 4 at randomization for two consecutive assessments (within 1 week)
- Change from baseline in CGI-S scores at 84 days [up to 84 days]
general condition assessment was made by CGI-S once a week, and calculated the total scores
- Change from baseline in Visual Analogue Scale (VAS) at 84 days [up to 84 days]
Methamphetamine craving assessment was made by VAS once a week, and calculated the total scores
- number of treatment day which calculated from randomization to the last visiting point [up to 84 days]
record the follow up time
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men and women aged 18 years to 60 years
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Met the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for METH dependence with psychosis
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Completing inpatient METH detoxification (≤30 days) with psychotic symptoms disappeared
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Beoff any anti-psychotic medication for 7 days after discharging from hospital were enrolled at clinical site
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Participants were interesting in reducing or stopping METH use
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Every patient also had a significant other (eg., spouse or relative) who supervised their compliance with the visit schedule and study procedures
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Women of childbearing potential agreed to use contraception during the study.
Exclusion criteria:
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Pregnancy or breastfeeding;
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Significant medical conditions (eg., acute renal failure, endocarditis, and tuberculosis); hepatic failure; past or present history of an AIDS-indicator disease; active hepatitis or aspartate amino transferase or alanine aminotransferase more than three times the upper limit of normal
-
Known intolerance or hypersensitivity to paliperidone ER; other psychosis; present dependence on substances other than METH or poly-substance abuse.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Second Xiangya Hospital of Central University | Changsha | Hunan | China | 410011 |
Sponsors and Collaborators
- Wei Hao
Investigators
- Study Director: Wei Hao, MD., Ph.D., Central South University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 100000-068944