UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015889 |
|---|---|
| Receipt number | R000018495 |
| Scientific Title | Effects of tramadol on cognitive functions in normal subjects using fMRI |
| Date of disclosure of the study information | 2014/12/10 |
| Last modified on | 2025/11/04 14:46:13 |
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Basic information
Public title
Effects of tramadol on cognitive functions in normal subjects using fMRI
Acronym
Effects of tramadol on cognitive functions in normal subjects using fMRI
Scientific Title
Effects of tramadol on cognitive functions in normal subjects using fMRI
Scientific Title:Acronym
Effects of tramadol on cognitive functions in normal subjects using fMRI
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effects of tramadol on human cognitive functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of BOLD signal changes measured by fMRI between placebo and tramadol conditions
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
1 day, 1 time, tramadol 50mg
washout duration 1 week
1 day, 1 time, placebo
Interventions/Control_2
1 day, 1 time, placebo
washout duration 1 week
1 day, 1 time, tramadol 50mg
Interventions/Control_3
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects with no history of psychiatric disorders.
Subjects who have the ability to provide informed consent and adhere to the protocol.
Key exclusion criteria
Subjects with drug allergy.
Subjects with history of epilepsy or seizure.
Subjects taking drugs within 2 weeks of the trial.
Subjects with liver or renal dysfunction.
Subjects who have tendency to drug abuse or drug dependence.
Pregnant woman and woman suspected of being pregnant.
Woman who is breastfeeding.
Subjects with contraindications to MRI.
Subjects who are judged as not suitable for participation in this study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Ikeda |
Organization
Nippon Medical School
Division name
Department of Pharmacology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
y-ikeda@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Ikeda |
Organization
Nippon Medical School
Division name
Department of Pharmacology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
y-ikeda@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Nippon Medical School Hospital
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
clinicaltrial@nms.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.jpain.org/article/S1526-5900(24)00628-X/abstract
Publication of results
Published
Result
URL related to results and publications
https://www.jpain.org/article/S1526-5900(24)00628-X/abstract
Number of participants that the trial has enrolled
48
Results
Tramadol decreased activation in the supramarginal gyrus during observation of other's pain compared with placebo. Supramarginal gyrus activation correlated negatively with the thermal pain threshold. Tramadol decreased activation in angular gyrus in cognitive empathy for pain compared
with placebo but did not change brain activity in emotional empathy for pain.
Results date posted
| 2025 | Year | 11 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Physically and psychiatrically healthy adults.
Participant flow
Forty-eight physically and psychiatrically healthy adults were recruited for the study. Fifteen participants were excluded. Thirty-three participants were included in the final analysis.
Adverse events
Nausea was reported under tramadol (n = 6). No serious adverse events were reported.
Outcome measures
Comparison of BOLD signal changes measured by fMRI between placebo and tramadol conditions
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018495
