Investigating the effectiveness of adding Clonidine and Gabapentin to Buprenorphine during detoxification of children and adolescents with Opioid Use Disorders

Investigating the effectiveness of adding Clonidine and Gabapentin to Buprenorphine during detoxification of children and adolescents with Opioid Use Disorders

Clinical trial with control group with randomized parallel groups on 40 patients

40 children aged 5 to 18 years with opioid use disorder will be studied according to the process of block randomization in two groups (buprenorphine) and (buprenorphine and clonidine and gabapentin). To collect information, the Opioid Withdrawal Clinical Symptoms Scale and the Opioid Withdrawal Mental Symptoms Scale will be completed on days 1 to 14. In both groups, buprenorphine will start at a dose of 2 mg per day and a maximum of 8 mg per day. Patients in the intervention group will also receive clonidine at a starting dose of 0.1 mg and then increase to 0.2 mg and gabapentin 100 to 300 mg three times daily.

Inclusion criteria:Diagnosis of opioid use disorder based on DSM-5 By child and adolescent psychiatrist ;age 5-18 years old. Exclusion Criteria:allergy to buprenorphine or clonidine or gabapentin; chronic or inflammatory diseases ; serious psychiatric illnesses ; Dissatisfaction of the patient's parent or Legal guardian to continue the plan

The control group receive 2 to 8 mg buprenorphine according to the protocol and in the intervention group receive 0.1 mg of clonidine in divided doses in first day then increased to 0.2 mg in latter days and gabapentin capsules at a dose of 100 to 300 mg every 8 hours from the first day in addition to buprenorphine.

Withdrawal symptoms according to psychiatrist examination and patient report

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.

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.

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.

Prior to the publication of the data, only the project executor and the main project partners.

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.

executor of plan. Main contributors. Kerman University of Medical Sciences and Neuroscience Center

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.