Methamphetamine DependenceNCT01825928
An Study of Paliperidone Extended-Release Tablets in the Treatment of Methamphetamine Dependence
A study testing Paliperidone in people with Methamphetamine Dependence, run by Wei Hao at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Methamphetamine Dependence
- What is being tested?
- Paliperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 years to 60 years
- Met the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for METH dependence with psychosis
- Completing inpatient METH detoxification (≤30 days) with psychotic symptoms disappeared
- Beoff any anti-psychotic medication for 7 days after discharging from hospital were enrolled at clinical site
- Participants were interesting in reducing or stopping METH use
- Every patient also had a significant other (eg., spouse or relative) who supervised their compliance with the visit schedule and study procedures
- Women of childbearing potential agreed to use contraception during the study.
Who cannot join
- Pregnancy or breastfeeding;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central University
Changsha, Hunan, 410011
About this study
Official title: Randomized, Double-blind, Placebo-controlled Trial of Paliperidone Extended-Release Tablets for The Treatment of Methamphetamine Dependence in Chinese Patients After Detoxification
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.
Read the detailed description
Methods:A Multiple-Center, Randomized, Double-Blind.
- Conditions
- Methamphetamine Dependence
- Being tested
- Paliperidone, placebo
- Keywords
- Methamphetamine, paliperidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaliperidoneDrug
Also called Paliperidone Extended-Release Tablets, Invega
Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days
placeboDrug
placebo group,3mg/pill,3mg/day forced titration method,last 84 days
| Study group | Role | What they receive |
|---|---|---|
| paliperidone | Experimental | paliperidone arm,3mg/pill,3mg/day.last84 days. Receives: Drug: Paliperidone |
| placebo | Placebo comparator | placebo group,3mg/pill,3mg/day non-forced titration method,last84 days. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 84 days
Secondary outcomes (4)
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)
Measured: 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
Measured: 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
Measured: up to 84 days
number of treatment day which calculated from randomization to the last visiting point
record the follow up time
Measured: up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wei Hao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Hao, Central South University
- Investigators
- Wei Hao, MD., Ph.D., Study director, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825928
- Sponsor's protocol ID
- 100000-068944
- Status last verified
- Jul 2017
- First submitted
- 28 Mar 2013
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Trial of Paliperidone Extended-Release Tablets for The Treatment of Methamphetamine Dependence in Chinese Patients After Detoxification
- ClinicalTrials.gov ID
- NCT01825928
- Acronym / sponsor ID
- 100000-068944
- Conditions
- Methamphetamine Dependence
- Keywords
- Methamphetamine, paliperidone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Wei HaoUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Methods:A Multiple-Center, Randomized, Double-Blind.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paliperidone | Experimental | Drug: Paliperidonepaliperidone arm,3mg/pill,3mg/day.last84 days. |
| placebo | Placebo comparator | Drug: placeboplacebo group,3mg/pill,3mg/day non-forced titration method,last84 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women aged 18 years to 60 years
- Met the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for METH dependence with psychosis
- Completing inpatient METH detoxification (≤30 days) with psychotic symptoms disappeared
- Beoff any anti-psychotic medication for 7 days after discharging from hospital were enrolled at clinical site
- Participants were interesting in reducing or stopping METH use
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaliperidoneAlso: Paliperidone Extended-Release Tablets, InvegaPaliperidone group,3mg/pill,3mg/day forced titration method,last 84 days | Drug | paliperidone |
| placeboplacebo group,3mg/pill,3mg/day forced titration method,last 84 days | Drug | placebo |
Primary outcome
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.
4 secondary outcomes
Time (day) to first psychosis relapse from baseline to 84 days
Time frame: up to 84 days
Change from baseline in CGI-S scores at 84 days
Time frame: up to 84 days
Change from baseline in Visual Analogue Scale (VAS) at 84 days
Time frame: up to 84 days
number of treatment day which calculated from randomization to the last visiting point
Time frame: up to 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Methamphetamine Dependence
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Hao, MD., Ph.D. study director
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paliperidone in people with Methamphetamine Dependence, run by Wei Hao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinent time of Methamphetamine addict (time frame: up to 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.