UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030849
Receipt No. 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 2019/06/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ikeda-kz@igakuken.or.jp

Sponsor
Institute National Center of Neurology and Psychiatry, National Center Hospital
Institute
Department

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
Email

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 No longer recruiting
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
2019 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035220

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.