]>
IRCT20090801002266N17 IRCT 2022-02-26 Esfahan University of Medical Sciences Memantine effect on pain tolerance time in MMTP patients Evaluation of memantine utilization on pain tolerance time in methadone- maintained patients 2021-11-06 anticipated 104 Complete https://irct.ir/trial/59521 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: cold pressor test will be done in all patients before drug adminstration and after 5 weeks of drug or plasibo adminstration, 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 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. 3 pain tolerance time. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There are no additional information
public Gholam Reza Kheirabadi
Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan University of Medical Sciences, Isfahan, IRAN
Isfahan Iran (Islamic Republic of) 8179999617 +98 31 1222 2135 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences scientific Golam Reza Kheirabadi
Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan University of Medical Sciences, Isfahan, IRAN
Isfahan Iran (Islamic Republic of) اصفهان +98 31 1222 2135 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Undertreatment in MMT program for at least 6 months No methadone dose modification in recent 6 months 18 years 65 years Both Any analgesic medication use Sedative drugs use Substance use disorder Any kind of psychiatric disorders Any kind of neuropathy, Raynaud’s disease Treatment - Drugs Placebo 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 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. 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. 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. Esfahan University of Medical Sciences Approved 2021-07-03 Ethics committee of Isfahan University of Medical Science Unit 3, Elahie apartment, No 2 Ave, No 9 street, Shahed Blvd, Sepahan Shahr, Isfahan Isfahan Isfehan Iran (Islamic Republic of)