Determining the average time of onset of cold pain and average duration of tolerating cold pain in patients Recipient of memantine and placebo before and five weeks after intervention and comparison of two means
Design
Randomised, placebo-control trial, phase 3 on 104 patients, with blinded patients, the examiner and analyser
Settings and conduct
Location of study: Shabnam methadone maintenance therapy clinic. A private clinic under the supervision of the Isfahan University of Medical Science. The patients, the examiner, and the analyzer are blinded.
The non-dominant limb is immersed in water at a temperature of about one degree Celsius and the time of onset of pain and the time of maximum pain tolerance are recorded. Prolongation of time of onset of pain and prolongation of the duration of maximum pain tolerance are considered as indicators of "Raising the pain tolerance threshold".
Participants/Inclusion and exclusion criteria
Inclusion criteria:
age between eighteen and sixty-five years
Physical health
Confirmation of patient addiction according to DSM V criteria
Patient consent to participate in the study
Exclusion criteria:
History of a psychiatric illness(Axis I or II).
The patient has one of the major physical diseases, including Peripheral neuropathies; Raynaud's syndrome; Neuropathic pain.
The patient's dissatisfaction with participation in the study or withdrawal
The patient becomes addicted to another substance or drug; including Amphetamines; cannabis; alcohol; benzodiazepines.
The patient regularly uses narcotic or non-narcotic analgesics for medical reasons.
Intervention groups
Intervention group:
Receive 5 mg daily memantine tablets in the first week and then increased by 5 mg per week up to 20 mg or as the patient tolerates
The control group:
Receive a placebo pill with the same appearance as the drug
Main outcome variables
Pain onset threshold and maximum pain tolerance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090801002266N17
Registration date:2022-02-26, 1400/12/07
Registration timing:retrospective
Last update:2022-02-26, 1400/12/07
Update count:0
Registration date
2022-02-26, 1400/12/07
Registrant information
Name
Gholamreza Kheirabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2135
Email address
kheirabadi@bsrc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of memantine utilization on pain tolerance time in methadone- maintained patients
Public title
Memantine effect on pain tolerance time in MMTP patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Undertreatment in MMT program for at least 6 months
No methadone dose modification in recent 6 months
Exclusion criteria:
Any analgesic medication use
Sedative drugs use
Substance use disorder
Any kind of psychiatric disorders
Any kind of neuropathy, Raynaud’s disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Each victim is assigned a number and based on a random number table, patients will be divided into two groups of placebo and medicine.
The process is such that both consecutive eligible entrants are considered as a block. The random method is such that if the random number is 4-0, it is assigned to group A and if it is 5-9, it is assigned to group B and then decodes A and B based on the type of treatment (in which group each patient was).
The medicine and placebo are poured into uniform envelopes and the patient number is written on each envelope and delivered to patients every week. Only the facilitator is aware of the table and which group the patient has entered, and the patient's test evaluator and examiner and the patient and the analyzer are blind.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are blinded for what group they are put in.
The cold pressor test utilizer is blinded for the patient's group
Analyzer will be blinded
Placebo
Used
Assignment
Parallel
Other design features
cold pressor test will be done in all patients before drug adminstration and after 5 weeks of drug or plasibo adminstration
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
Unit 3, Elahie apartment, No 2 Ave, No 9 street, Shahed Blvd, Sepahan Shahr, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8179999617
Approval date
2021-07-03, 1400/04/12
Ethics committee reference number
IR.MUI.MED.REC.1400.261
Health conditions studied
1
Description of health condition studied
pain tolerance time
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean threshold of pain in cold pressor test
Timepoint
In the beginning of study and after 5 weeks of memantine or placebo
Method of measurement
Cold peressor test; stopwatch
2
Description
Mean duration of maximum pain tolerance in Cold pressor test
Timepoint
In the beginning of the study and after 5 weeks of memantine or placebo administration
Method of measurement
Cold professor test will be performed for patients and the time of onset of pain and maximum pain tolerance will be measured with a stopwatch
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: memantine tablet administration. Start with 5 mg per day in the first week and adding 5 mg per day every week until patient tolerates or maximum dose 20 mg per day for 5 weeks from beginning
Category
Treatment - Drugs
2
Description
Control group: placebo administration with a completely similar appearance to memantine tablets produced by the Faculty of Pharmacy of Isfahan University of Medical Sciences. One pill in the first week and then increase one daily pill weekly to a maximum of 4 pills a day or no patient tolerance for 5 weeks from beginning.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shabnam drug use treatment clinic
Full name of responsible person
Arman Otroshi
Street address
No 31, Hakim Nasr allah Street, Shahreza
City
Shahreza
Province
Isfehan
Postal code
۸۶۱۹۷۸۳۹۵۱
Phone
+98 31 5322 5115
Email
arman_otroshi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansoor siavash
Street address
Hezarjarb St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Gholam Reza Kheirabadi
Position
Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan University of Medical Sciences, Isfahan, IRAN
City
Isfahan
Province
Isfehan
Postal code
8179999617
Phone
+98 31 1222 2135
Fax
+98 31 1222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Golam Reza Kheirabadi
Position
Prof. of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan University of Medical Sciences, Isfahan, IRAN
City
Isfahan
Province
Isfehan
Postal code
اصفهان
Phone
+98 31 1222 2135
Fax
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholam Reza Kheirabadi
Position
Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan University of Medical Sciences, Isfahan, IRAN
City
Isfahan
Province
Isfehan
Postal code
اصفهان
Phone
+98 31 1222 2135
Fax
+98 31 1222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
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