UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035220