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IRCT20090801002266N18 IRCT 2022-08-02 Esfahan University of Medical Sciences Comparison of a modified method of opioid dependence management with the Ministry of Health and Medical Education of Iran method A comparative study of the effect of a modified method of opioid dependence management with the current method proposed by the Ministry of Health and Medical Education of Iran, on satisfaction, craving and relapse in opioids users. 2022-06-24 anticipated 230 Complete https://irct.ir/trial/63735 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The selection of samples is consecutive sampling and will be continued until the required sample size is completed. The intervention and control group will be selected from the clients of the Ariana addiction treatment center in Isfahan (the original center of the modified addiction treatment method). The samples will be selected into two study groups through double random blocks of random allocation. In this way, both eligible people will be in one block and then they will be randomly assigned to one of the study groups. This process will be continued until reaching the required sample size of 230, Blinding description: This study is double-blind, so the participants and those responsible for data collection will be blinded. In such a way both the person participating in the study and the evaluator will not know whether the participant belongs to the intervention group or the control group. 3 Detoxification in regular and daily users of opium or heroin orally, injected or smoked. Intervention 1: Intervention group: With the onset of withdrawal symptoms, we begin treatment with 0.1 mg of clonidine. Then 2 to 4 mg of sublingual buprenorphine is prescribed (2 mg for amounts less than 3 g of opium or equivalent). If there are symptoms of withdrawal, adjuvant drugs are used and the type and dose used and the reason for administration are recorded accurately. To control restlessness and muscle tension, 10 mg of chlorpheniramine is injected and if not controlled, 5 to 10 mg of diazepam is prescribed.We use 4 to 8 mg of dexamethasone to control pain. On the second day, the patient is evaluated and in the absence of obvious withdrawal symptoms, no intervention is performed, and if there are annoying and obvious withdrawal symptoms, we repeat the steps of the first day.On the third day, the patient is re-evaluated and if the withdrawal symptoms are not severe and annoying, start treatment with clonidine and adjuvants as appropriate and buprenorphine is no longer prescribed, but if the withdrawal symptoms were obvious and annoying on the third day, We prescribe 2 mg of buprenorphine sublingually and re-evaluate after one hour. If symptoms persist, the dose is repeated and treatment with clonidine and other adjuvants will be delayed until the fourth day.The protocol for administering clonidine is as follows: From the third day, in the absence or mild withdrawal symptoms, buprenorphine administration is completely discontinued and clonidine administration is started. If withdrawal symptoms are severe, treatment with clonidine and other adjuvant medications should be started from the fourth day. 0.1 mg of clonidine is given every night before bed and this process will be continued for ten days. If the blood pressure drops to less than 85/55 mm Hg, the next dose of clonidine will be not prescribed, the drug will be reduced and discontinued, and if the hypotension persists for more than 4 hours, clonidine will be discontinued. To assess the severity of withdrawal symptoms and possible complications, the patient will be visited 1 to 3 times a week, the dose of medication is adjusted. Also, the cause and amount of prescribed medications are carefully recorded.To follow up and prevent of recurrency: In the first trimester, patients can visit the doctor freely and whenever they need. In addition, on a weekly basis, they will be invited to the center by phone to talk about their situation during the week and how to manage their cravings. In the second trimester every week and in the next six months every two weeks the patient will be contacted. Intervention 2: Control group: According to the method proposed by the Ministry of Health of Iran for outpatient detoxification with buprenorphine, after that withdrawal symptoms appear, 2 to 5 mg of sublingual buprenorphine will be administered and the patient will be evaluated one hour later. If there are withdrawal symptoms, the dose will be repeated. It should be noted that the maximum dose of administered buprenorphine on the first day is 8 mg. If there are no withdrawal symptoms, the drug is enough for the first day. If there are withdrawal symptoms, adjuvant medications should be used. The type of adjuvant medications, doses and the reason for receiving medications will be carefully recorded. On the second day, the dose of buprenorphine will be increased to 2 to 5 mg. We aim to stabilize the patient as quickly as possible, minimize withdrawal symptoms, and reduce substance consumption. The dose reduction phase begins when the patient stops consumption. The dose reduction phase can be continued from a few days to several weeks. The method of the decrease buprenorphine dose is reducing 1 mg every 2 to 3 days until it is completely stopped, which on average this period will last 2 to 4 days. If withdrawal symptoms worsen during these ten days, the dose should be increased and the reduction process should be slowed down again. In addition, for some symptoms, adjuvant medications (tricyclics, especially amitriptyline, NSAIDs, benzodiazepines, baclofen, antihistamines, antipsychotics, metoclopramide, chlorpromazine, and hyoscine) will be used. The dose and cause of administration are also recorded. At the end of this detoxification period and 3-5 days after the last dose of buprenorphine is administered, Naltrexone will be started to prevent recurrency. Before starting treatment with naltrexone (according to the Ministry's protocol), the following should be considered: The patient should not have used any opioids during this period. To ensure detoxification, the Naloxone Challenge Test should be performed.This test can be done either intravenously or subcutaneously. 6 mg of naltrexone daily is sufficient to prevent recurrence of opioid use. Naltrexone capsules should be taken as a water-soluble capsule at least for the first few weeks under family supervision and if the patient agrees.The patient will be visited once a week for the first 6 weeks and once every two weeks for several months. After that, the visits are reduced to once a month. At each visit, naltrexone is dissolved in water and in the presence of a physician. Prevention of recurrence with naltrexone will be continued for 6 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr. Gholamreza Kheirabadi
Behavioral Sciences Research Center, Khorshid Hospital, Ostandari Street.
Isfehan Iran (Islamic Republic of) 8145831451 +98 31 3222 2135 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences scientific Dr Gholamreza Kheirabadi
Behavioral Sciences Research Center, Khorshid Hospital, Ostandari Street.
Isfehan Iran (Islamic Republic of) 8145831451 +98 31 3222 2135 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Consent to participate in the study Having DSM-5 criteria for drug dependence Regular and daily consumption of opium or heroin orally, injected or smoked Not using other substances Age 20 to 60 years Absence of major psychiatric disorders and absence of physical illness, which is a ban on withdrawing drugs Not taking psychiatric drugs or any drugs that affects the central nervous system 20 years 60 years Both The patient's unwillingness to continue cooperation Occurrence of any medical or ethical conflict with the patient's continued participation in the research Occurrence of physical and mental problems requires special interventions in the process of withdrawing drugs Returning to substance abuse in the treatment process F11.23 Opioid dependence with withdrawal Treatment - Drugs Treatment - Drugs Intervention group: With the onset of withdrawal symptoms, we begin treatment with 0.1 mg of clonidine. Then 2 to 4 mg of sublingual buprenorphine is prescribed (2 mg for amounts less than 3 g of opium or equivalent). If there are symptoms of withdrawal, adjuvant drugs are used and the type and dose used and the reason for administration are recorded accurately. To control restlessness and muscle tension, 10 mg of chlorpheniramine is injected and if not controlled, 5 to 10 mg of diazepam is prescribed.We use 4 to 8 mg of dexamethasone to control pain. On the second day, the patient is evaluated and in the absence of obvious withdrawal symptoms, no intervention is performed, and if there are annoying and obvious withdrawal symptoms, we repeat the steps of the first day.On the third day, the patient is re-evaluated and if the withdrawal symptoms are not severe and annoying, start treatment with clonidine and adjuvants as appropriate and buprenorphine is no longer prescribed, but if the withdrawal symptoms were obvious and annoying on the third day, We prescribe 2 mg of buprenorphine sublingually and re-evaluate after one hour. If symptoms persist, the dose is repeated and treatment with clonidine and other adjuvants will be delayed until the fourth day.The protocol for administering clonidine is as follows: From the third day, in the absence or mild withdrawal symptoms, buprenorphine administration is completely discontinued and clonidine administration is started. If withdrawal symptoms are severe, treatment with clonidine and other adjuvant medications should be started from the fourth day. 0.1 mg of clonidine is given every night before bed and this process will be continued for ten days. If the blood pressure drops to less than 85/55 mm Hg, the next dose of clonidine will be not prescribed, the drug will be reduced and discontinued, and if the hypotension persists for more than 4 hours, clonidine will be discontinued. To assess the severity of withdrawal symptoms and possible complications, the patient will be visited 1 to 3 times a week, the dose of medication is adjusted. Also, the cause and amount of prescribed medications are carefully recorded.To follow up and prevent of recurrency: In the first trimester, patients can visit the doctor freely and whenever they need. In addition, on a weekly basis, they will be invited to the center by phone to talk about their situation during the week and how to manage their cravings. In the second trimester every week and in the next six months every two weeks the patient will be contacted. Control group: According to the method proposed by the Ministry of Health of Iran for outpatient detoxification with buprenorphine, after that withdrawal symptoms appear, 2 to 5 mg of sublingual buprenorphine will be administered and the patient will be evaluated one hour later. If there are withdrawal symptoms, the dose will be repeated. It should be noted that the maximum dose of administered buprenorphine on the first day is 8 mg. If there are no withdrawal symptoms, the drug is enough for the first day. If there are withdrawal symptoms, adjuvant medications should be used. The type of adjuvant medications, doses and the reason for receiving medications will be carefully recorded. On the second day, the dose of buprenorphine will be increased to 2 to 5 mg. We aim to stabilize the patient as quickly as possible, minimize withdrawal symptoms, and reduce substance consumption. The dose reduction phase begins when the patient stops consumption. The dose reduction phase can be continued from a few days to several weeks. The method of the decrease buprenorphine dose is reducing 1 mg every 2 to 3 days until it is completely stopped, which on average this period will last 2 to 4 days. If withdrawal symptoms worsen during these ten days, the dose should be increased and the reduction process should be slowed down again. In addition, for some symptoms, adjuvant medications (tricyclics, especially amitriptyline, NSAIDs, benzodiazepines, baclofen, antihistamines, antipsychotics, metoclopramide, chlorpromazine, and hyoscine) will be used. The dose and cause of administration are also recorded. At the end of this detoxification period and 3-5 days after the last dose of buprenorphine is administered, Naltrexone will be started to prevent recurrency. Before starting treatment with naltrexone (according to the Ministry's protocol), the following should be considered: The patient should not have used any opioids during this period. To ensure detoxification, the Naloxone Challenge Test should be performed.This test can be done either intravenously or subcutaneously. 6 mg of naltrexone daily is sufficient to prevent recurrence of opioid use. Naltrexone capsules should be taken as a water-soluble capsule at least for the first few weeks under family supervision and if the patient agrees.The patient will be visited once a week for the first 6 weeks and once every two weeks for several months. After that, the visits are reduced to once a month. At each visit, naltrexone is dissolved in water and in the presence of a physician. Prevention of recurrence with naltrexone will be continued for 6 months. Instant craving score in the Desires for Drug Questionnaire. Timepoint: The patient will be visited once a week for the first 2 weeks and once every two weeks for several months. After that, the visits are reduced to once a month. At each visit, the patient is examined by a physician. Method of measurement: Desires for Drug Questionnaire. Reduction of cases of withdrawal from treatment. Timepoint: In both groups, data related to cases of non-referral and non-follow-up treatment will be recorded and compared at the end of the intervention and follow-up period. Method of measurement: Registration in the patient follow-up checklist. The level of satisfaction with the detoxification process and the one-year follow-up period. Timepoint: The end of the detoxification period and the end of the one-year follow-up period. Method of measurement: at the end of detoxification period and at the end of one-year follow-up period) in the form of two questions in the text of the questionnaire and using It is measured by the Likert scoring scale. Esfahan University of Medical Sciences Approved 2022-04-11 Ethics Committee in Research, School of Medicine, Isfahan University of Medical Sciences Behavioral Sciences Research Center, Khorshid Hospital, Ostandari Street Isfehan Isfehan Iran (Islamic Republic of)