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IRCT201707252266N7 IRCT 2017-08-10 Isfahan University of Medical Sciences comparisson of gabapentne and pregabalin in controling of opioid withdrawal A comparative study of Pregabalin and gabapentin on the control of opioid withdrawal symptoms 2017-04-04 anticipated 60 Complete https://irct.ir/trial/1906 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Opium Dependency. Intervention 1: pregabalin group:patients in this groups will be receive Bupronorphine. Bupronorphine dose will be adjusted based on patients need and all of them will be stabilized on Bupronorphine during 3-5 days. We will start tapering of Bupronorphine at 7th days with a same pattern for all the patients during 2 weeks and the final dose of Bupronorphine will be prescribed at 21th day. Pegabalin produced by sobhan darou Tehran,Iran will be started with dose of 150mg in the first week and the dose will be increased to 300mg for next week. Finally in 3rd and 4th weeks patients will be recieve 450mg of pregabalin/day. Intervention 2: Gabapentine group: patients in this groups will be receive Bupronorphine. Bupronorphine dose will be adjusted based on patients need and all of them will be stabilized on Bupronorphine during 3-5 days. We will start tapering of Bupronorphine at 7th days with a same pattern for all the patients during 2 weeks and the final dose of Bupronorphine will be prescribed at 21th day. We will start tapering of Bupronorphine at 7th days with a same pattern for all the patients during 2 weeks and the final dose of Bupronorphine will be prescribed at 21th day. Gabapentine produced by sobhan darou Tehran,Iran will be started with dose of 400 mg/day in the first week, 800mg in second week and the dose will be increased to 1600mg in 3rd and 4th weeks. Intervention 3: Placebo group: patients in this groups al so will be receive Bupronorphine. Bupronorphine dose will be adjusted based on patients need and all of them will be stabilized on Bupronorphine during 3-5 days. We will start tapering of Bupronorphine at 7th days with a same pattern for all the patients during 2 weeks and the final dose of Bupronorphine will be prescribed at 21th day. Placebo produced by department of pharmacology in Isfahan University of medical sciences will be started and continued in the same manner of gabapentine and pregabalin groups.
public Dr Gholam Reza Kheirabadi
Department of psychiatry, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) +98 31 3222 2135 kheirabadi@bsrc.mui.ac.ir Isfahan University of Medical Sciences scientific Dr Gholam Reza Kheirabadi
Department of psychiatry, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) +98 31 3222 2135 kheirabadi@bsrc.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: having DSM-V criteria for drug dependence; regular orally/smoking daily consumption of opium; using no other medication including psychiatric drugs and also other substances except cigarette; not taking pain medications; absence of other comorbid psychiatric disorders; not having any special disease which causes opium withdrawal prohibition; no contraindication for pregabalin and gabapentin consumption . Exclusion criteria : lack of patients' interest for participation and continuation of study; any ethical or medical conflict for continuation; incidence of any physical/mental complication that needs special interventions. ;pregnancy and brestfeeding. 20 years 50 years Both F11 Mental and behavioural disorders due to use of opioids Treatment - Drugs Treatment - Drugs Treatment - Drugs pregabalin group:patients in this groups will be receive Bupronorphine. Bupronorphine dose will be adjusted based on patients need and all of them will be stabilized on Bupronorphine during 3-5 days. We will start tapering of Bupronorphine at 7th days with a same pattern for all the patients during 2 weeks and the final dose of Bupronorphine will be prescribed at 21th day. Pegabalin produced by sobhan darou Tehran,Iran will be started with dose of 150mg in the first week and the dose will be increased to 300mg for next week. Finally in 3rd and 4th weeks patients will be recieve 450mg of pregabalin/day. Gabapentine group: patients in this groups will be receive Bupronorphine. Bupronorphine dose will be adjusted based on patients need and all of them will be stabilized on Bupronorphine during 3-5 days. We will start tapering of Bupronorphine at 7th days with a same pattern for all the patients during 2 weeks and the final dose of Bupronorphine will be prescribed at 21th day. We will start tapering of Bupronorphine at 7th days with a same pattern for all the patients during 2 weeks and the final dose of Bupronorphine will be prescribed at 21th day. Gabapentine produced by sobhan darou Tehran,Iran will be started with dose of 400 mg/day in the first week, 800mg in second week and the dose will be increased to 1600mg in 3rd and 4th weeks Placebo group: patients in this groups al so will be receive Bupronorphine. Bupronorphine dose will be adjusted based on patients need and all of them will be stabilized on Bupronorphine during 3-5 days. We will start tapering of Bupronorphine at 7th days with a same pattern for all the patients during 2 weeks and the final dose of Bupronorphine will be prescribed at 21th day. Placebo produced by department of pharmacology in Isfahan University of medical sciences will be started and continued in the same manner of gabapentine and pregabalin groups. Severity of opium withdrawal. Timepoint: first, 7th, 15th and 22th days. Method of measurement: Qustionair. Drugs sideffects. Timepoint: first, 7th, 15th, 22th days. Method of measurement: check list. Isfahan University of Medical Sciences Approved 2017-03-10 Isfahan University of medical sciences Isfahan Isfahan Iran (Islamic Republic of)