UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030849 |
|---|---|
| Receipt number | R000035220 |
| Scientific Title | Study of ifenprodil effects on patients with methamphetamine dependence and development of fMRI biomarkers for methamphetamine dependence |
| Date of disclosure of the study information | 2018/01/17 |
| Last modified on | 2021/01/19 10:15:45 |
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Basic information
Public title
Study of ifenprodil effects on patients with methamphetamine dependence and development of fMRI biomarkers for methamphetamine dependence
Acronym
Study of ifenprodil in methamphetamine dependence
Scientific Title
Study of ifenprodil effects on patients with methamphetamine dependence and development of fMRI biomarkers for methamphetamine dependence
Scientific Title:Acronym
Study of ifenprodil in methamphetamine dependence
Region
| Japan |
Condition
Condition
Stimulant Use Disorder (amphetamine-type substance)
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have two purposes in the present study.
1) To investigate effects of ifenprodil treatment on patients with methamphetamine dependence and find a primary endpoint in a double-blind, placebo-controlled trial.
2) To develop fMRI biomarkers for methamphetamine dependence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The presence or absence of methamphetamine use during the 84-day administration period of ifenprodil or placebo.
Key secondary outcomes
1) The days and percentage of days abstinent from methamphetamine during the 84-day administration period (assessed by self-reports using the Timeline Follow-back method). The days and percentage of days of methamphetamine use during the 84-day administration period (assessed by self-reports using the Timeline Follow-back method).
2) Positive urine for methamphetamine (positive/negative, number of times, ratio) during the 84-day administration period.
3) Relapse risk (the Stimulant Relapse Risk Scale).
4) Drug craving (Numerical Rating Scale, 11-point scale).
5) Above outcomes assessed for 6 months (including 3 months after the medication).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ifenprodil (120 mg/day, 84 days)
Interventions/Control_2
Ifenprodil (60 mg/day, 84 days)
Interventions/Control_3
Placebo (84 days)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Outpatients who were diagnosed with methamphetamine use disorder assessed by DSM-5 (including first visit and return visit).
2) Those who used methamphetamine in the past year.
3) Those who are age 20 years old <= at obtaining of informed consent.
Key exclusion criteria
1) Patients with severe physical diseases.
2) Patients with high suicide risk.
3) Patients with severe symptoms of substance-induced psychotic disorder.
4) Patients with impaired cognitive function.
5) Patients who do not wish to be notified of the fMRI examination results.
6) Patients judged ineligible to participate in the study by the attending psychiatrist.
7) Patients taking paroxetine.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Matsumoto |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Drug Dependence Research, National Institute of Mental Health
Zip code
Address
4-1-1 Ogawahigashi-machi, Kodaira-shi, Tokyo, JAPAN
TEL
042-346-1953
tmatsu@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutaka Ikeda |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Department of Psychiatry and Behavioral Sciences, Addictive Substance Project
Zip code
Address
2-1-6 Kamikitazawa Setagaya-ku, Tokyo, JAPAN
TEL
03-6834-2379
Homepage URL
ikeda-kz@igakuken.or.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry, National Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Metropolitan Institute of Medical Science, National Center of Neurology and Psychiatry (Integrative Brain Imaging Center), Kyoto University, Advanced Telecommunications Research Institute International
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立精神・神経医療研究センター病院（東京都）
National Center of Neurology and Psychiatry, National Center Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 12 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 07 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 17 | Day |
Last modified on
| 2021 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035220
