Effectiveness of memantine on OIH in opioid addict patients
Design
Patients with opioid-induced hyperalgesia diagnose divided to 2 groups accidently by rand function of excel software and the first group treated with memantine and the other group with placebo.
The patients do not know about intake of drug or placebo.
Settings and conduct
The patients put his hand in cold water with 1to5 celsius degree and after pain feeling and exit hand this time will be the first CPT. then we asses changes of this time and pain numbers after treatment with memantine. So analysis data with SPSS software will done.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.opioid addict patients
2.from 18 to 60 years old
3.filling satisfaction form
4.no multi substance use in patients
5.no neurologic or nephrologic dysfunction
6.no unstable medical states
7.no Raynauds disease
Exit criteria:
1.use other substance such as stimulants
2.memantine allergy
3.pregnancy
Intervention groups
We choose 34 opioid addict patients in beheshti hospital with intake of enough analgesics from NSAIDS with maximum allowed dose, that have complaints of pain and asses with Cold pressor test and grading by FACES pain numbres.
patients with opioid-induced hyperalgesia diagnose divided to 2 groups and the first group treated with memantine and the other group with placebo.
Main outcome variables
severity of pain ranking by patients from 0 to 10
time of stay patients hand in cold water
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211112053045N1
Registration date:2021-12-07, 1400/09/16
Registration timing:prospective
Last update:2021-12-07, 1400/09/16
Update count:0
Registration date
2021-12-07, 1400/09/16
Registrant information
Name
Nafise sadat Haji seyed taghia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4000
Email address
na_hst@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of memantine on opioid-induced hyperalgesia in opioid addict patients
Public title
Effectiveness of memantine on opioid-induced hyperalgesia in opioid addict patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
opioid addict patients
from 18 to 60 years old
filling satisfaction form
no multi substance use in patients
no neurologic or nephrologic dysfunction
no unstable medical states
no Raynauds disease
Exclusion criteria:
use other substance such as stimulants
memantine allergy
pregnancy
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Patients inter to our study based on simple accidently & respectively. Because of defined the number of patients of sample size in every group & they inter one by one ,before starting study, the order of 34 patients had set. For 17numbers drug & for other 17numbers placebo will give accidently. So before inter one person to study, intake of drug or placebo had set by predetermined list.
Blinding (investigator's opinion)
Single blinded
Blinding description
We accidently divide patients to 2 groups of control and intervention.
The patients do not know about intake drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
darvaze ark. beheshti hospital
City
zanjan
Province
Zanjan
Postal code
4513615788
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.ZUMS.REC.1400.264
Health conditions studied
1
Description of health condition studied
Effectiveness of memantine on OIH in opioid addict patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
severity of pain ranking by patients from 0 to 10
Timepoint
checking of patients one day before start memantine & at the end of second & forth week after treatment
Method of measurement
ranking by patients from 0 to 10
2
Description
time of stay patients hand in cold water
Timepoint
checking of patients one day before start memantine & at the end of second & forth week after treatment
Method of measurement
Cold pressor test time in seconds
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 18 to 60 years old opioid addict patients in Beheshti hospital with intake of enough analgesics from NSAIDS with maximum allowed dose, that have complaints of pain, & with OIH diagnose based on cold pressor test, divided 2 groups randomize & this group will receive memantine 10 MG daily.
Category
Treatment - Drugs
2
Description
Control group: Intervention group: 18 to 60 years old opioid addict patients in Beheshti hospital with intake of enough analgesics from NSAIDS with maximum allowed dose, that have complaints of pain & with OIH diagnose based on cold pressor test, divided 2 groups randomize & this group will receive placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Ahmad Zolghadriha
Street address
Darvaze ark. Beheshti hospital
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4000
Email
na_hst@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Vice chancellor for research Zanjan University of Medical Sciences.Dr.Alireza Shoghli
Street address
Besat street
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4000
Email
Beheshti@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ahmad Zolghadriha
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Darvaze ark. Beheshti hospital
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
009833544000
Email
Ahmad_zolghadriha@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Elham Faghihzade
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Darvaze ark. Beheshti hospital
City
زنجان
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4000
Email
e.faghihzadeh@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nafise sadat Haji seyed taghia
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Darvaze ark. Beheshti hospital
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4000
Email
Na¬_hst@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available