An interventional study of Paliperidone and placebo in Methamphetamine Dependence, sponsored by Wei Hao. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-07-13.
Sponsored by Wei Hao · Not applicable, Interventional, and Treatment
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.
Wei Hao is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
paliperidone arm,3mg/pill,3mg/day.last84 days.
Drug: Paliperidone
placebo group,3mg/pill,3mg/day non-forced titration method,last84 days.
Drug: placebo
Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days
Also known as: Paliperidone Extended-Release Tablets, Invega
placebo group,3mg/pill,3mg/day forced titration method,last 84 days
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.
Time frame: up to 84 days
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)
Time frame: 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
Time frame: 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
Time frame: up to 84 days
number of treatment day which calculated from randomization to the last visiting point
record the follow up time
Time frame: up to 84 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Wei Hao