An Study of Paliperidone Extended-Release Tablets in the Treatment of Methamphetamine Dependence
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|ClinicalTrials.gov Identifier: NCT01825928|
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Methamphetamine Dependence||Drug: Paliperidone Drug: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Double-blind, Placebo-controlled Trial of Paliperidone Extended-Release Tablets for The Treatment of Methamphetamine Dependence in Chinese Patients After Detoxification|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||July 2014|
paliperidone arm,3mg/pill,3mg/day.last84 days.
Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days
Placebo Comparator: placebo
placebo group,3mg/pill,3mg/day non-forced titration method,last84 days.
placebo group,3mg/pill,3mg/day forced titration method,last 84 days
- Abstinent time of Methamphetamine addict [ Time Frame: 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.
- Time (day) to first psychosis relapse from baseline to 84 days [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to 84 days ]record the follow up time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825928
|The Second Xiangya Hospital of Central University|
|Changsha, Hunan, China, 410011|
|Study Director:||Wei Hao, MD., Ph.D.||Central South University|