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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.
Methods:A Multiple-Center, Randomized, Double-Blind.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paliperidone | Experimental | paliperidone arm,3mg/pill,3mg/day.last84 days. |
|
| placebo | Placebo Comparator | placebo group,3mg/pill,3mg/day non-forced titration method,last84 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone | Drug | Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Abstinent time of Methamphetamine addict | 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. | up to 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time (day) to first psychosis relapse from baseline 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) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Hao, MD., Ph.D. | Central South University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central University | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo | Drug | placebo group,3mg/pill,3mg/day forced titration method,last 84 days |
|
| up to 84 days |
| Change from baseline in CGI-S scores at 84 days | general condition assessment was made by CGI-S once a week, and calculated the total scores | up to 84 days |
| Change from baseline in Visual Analogue Scale (VAS) at 84 days | Methamphetamine craving assessment was made by VAS once a week, and calculated the total scores | up to 84 days |
| number of treatment day which calculated from randomization to the last visiting point | record the follow up time | up to 84 days |
| D011743 |
| Pyrimidines |