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IRCT20110411006168N5 IRCT 2023-04-29 Kerman University of Medical Sciences The efficacy of Buspirone on withdrawal symptoms in children and adolescents with substance use disorder on treatment with buprenorphine The efficacy of Buspirone on withdrawal symptoms in children and adolescents with substance use disorder on treatment with buprenorphine 2022-10-23 anticipated 40 Complete https://irct.ir/trial/65993 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This clinical study will be conducted using blocked randomization scheme. In this trial with 40 individuals, this scheme randomizes individuals by performing a block randomization with equal block sizes of four participant randomly ordered, making sure two of them are with the “A” card representing treatment group and two with the “B” card representing control group. Allocation proceeds by sortition selecting one of the ordering of each block to finalize a sequence of 40 aforementioned cards. Each card is placed in an envelope, sealed and placed in the same order. Finally, for each patient enters the study, the corresponding envelope to their sequence is opened to determine the group allocation, Blinding description: Buspirone and placebo tablets are completely similar in terms of color and size, and neither the researcher nor the patient will know the type of drug prescribed. N/A Opioid Use Disorders. Intervention 1: Intervention group: After emergence of withdrawal symptoms, an average of 2 mg of buprenorphine is started in two divided doses and if needed, 2 mg of buprenorphine up to a maximum of 8 mg is given to patients every 2 hours, and the second day is equivalent to the first day dose or if mild to moderate withdrawal symptoms are emerged, 2-4 mg buprenorphine more than the first day (maximum 8 mg) will be prescribed. From the 4th day, gradually decrease to 0.5 to 1 mg daily to be discontinued. In addition on the first day, 0.5 mg/kg of buspirone is given to patients in divided doses three times a day, and increased to a maximum dose of 15 to 45 mg per day until the end of the study. Intervention 2: Control group: after emergence of withdrawal symptoms, an average of 2 mg of buprenorphine is started in two divided doses and if needed, 2 mg of buprenorphine up to a maximum of 8 mg is given to patients every 2 hours, and the second day is equivalent to the first day dose or if mild to moderate withdrawal symptoms have emerged, 2-4 mg buprenorphine more than the first day (maximum 8 mg) will be prescribed.From the 4th day, gradually decrease to 0.5 to 1 mg daily to be discontinued. Also, from the first day, they receive a placebo pill of the same shape and size as buspirone. Yes - There is a plan to make this available What will be shared: At the end of the study and after its approval and analysis, the study is supposed to be in the form of an article, in which part of the data is mentioned and not necessarily all of it. The data will be available after the patients are not identified, and specialized and enthusiastic people will be able to access the participants' data file. When: After completing the study and obtaining permission from the project manager and the University of Medical Sciences. Approximately 1 to 2 years after the end of the study. To whom: Prior to the publication of the data, only the project executor and the main project partners. Conditions: Files are provided to specific individuals only after the completion of the study and with the permission of the University of Medical Sciences for the use of data for use in meta-analysis studies and systematic reviews. Where to obtain: executor of plan. Main contributors. Kerman University of Medical Sciences and Neuroscience Center How to obtain: In order to receive the published files, the necessary permits must be obtained from Kerman University of Medical Sciences and the Center for Neuroscience and Executors Comments:
public Dr. Mahin Eslami Sharbabaki
Shahid Beheshti Hospital, Jomhori Bulv ,Kerman
kerman Iran (Islamic Republic of) 7618834115 +98 34 3211 7623 m_eslami@kmu.ac.ir Kerman University of Medical Sciences scientific Dr. Mahin Eslami Sharbabaki
Shahid Beheshti Hospital, Jomhori Bulv ,Kerman
kerman Iran (Islamic Republic of) 7618834115 +98 34 3211 7623 m_eslami@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Diagnosis of opioid use disorder based on DSM-5 by a child and adolescent psychiatrist age 5-18 years old 5 years 18 years Both Allergy to buprenorphine orBuspirone. .Chronic or inflammatory diseases (heart, lung, liver, kidney or neurological diseases such as epilepsy) Serious psychiatric illnesses such as schizophrenia and other psychotic disorders, acute phase of bipolar disorder and moderate to severe mental disability Dissatisfaction of the patient's parent or Legal guardian to continue the plan. F11.1 Opioid abuse Treatment - Drugs Placebo Intervention group: After emergence of withdrawal symptoms, an average of 2 mg of buprenorphine is started in two divided doses and if needed, 2 mg of buprenorphine up to a maximum of 8 mg is given to patients every 2 hours, and the second day is equivalent to the first day dose or if mild to moderate withdrawal symptoms are emerged, 2-4 mg buprenorphine more than the first day (maximum 8 mg) will be prescribed. From the 4th day, gradually decrease to 0.5 to 1 mg daily to be discontinued. In addition on the first day, 0.5 mg/kg of buspirone is given to patients in divided doses three times a day, and increased to a maximum dose of 15 to 45 mg per day until the end of the study. Control group: after emergence of withdrawal symptoms, an average of 2 mg of buprenorphine is started in two divided doses and if needed, 2 mg of buprenorphine up to a maximum of 8 mg is given to patients every 2 hours, and the second day is equivalent to the first day dose or if mild to moderate withdrawal symptoms have emerged, 2-4 mg buprenorphine more than the first day (maximum 8 mg) will be prescribed.From the 4th day, gradually decrease to 0.5 to 1 mg daily to be discontinued. Also, from the first day, they receive a placebo pill of the same shape and size as buspirone. Withdrawal symptoms according to psychiatrist examination and patient report. Timepoint: days 1 to 14. Method of measurement: Clinical opioid withdrawal scale and subjective opioid withdrawal scale. Drug side effects. Timepoint: day 1 to 14. Method of measurement: Checklist of drug side effects. Kerman University of Medical Sciences Approved 2022-09-21 Working Group / Research Ethics Committee of Kerman University of Medical Sciences the beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences kerman Kerman Iran (Islamic Republic of)