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IRCT20230914059433N1 IRCT 2023-10-12 Arak University of Medical Sciences Comparison of effect of methadone and methadone adjuvant Olanzapine on treatment in heroin and methamphetamine dependents with Novelty seeking temperament Comparison of the effectiveness of methadone and temperament-based pharmacotherapy on treatment retention, relapse, and treatment boredom in heroin and methamphetamine dependents 2023-04-04 anticipated 42 Complete https://irct.ir/trial/72634 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be assigned to two intervention and control groups based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 2 blocks will be used to allocate the samples. In this way, by using the block method random number generation software, the randomization sequence will be produced according to the required sample size for two groups. In the beginning, all the modes where 2 letters A and B can be put together in a block of 2 are produced. Then a block will be selected randomly and by placement among the blocks, and the arrangement pattern in that block will be used to allocate the participants. Then this block will be placed in the main container and another block will be selected again. All these works will be done with a software called Sealed Envelope. Using this method, concealment will also be observed. The concept of concealment is the unpredictability of assigning people to groups. In fact, the researcher will not be able to predict which group the next person will be in, Blinding description: It only happens when the data analysis is done in such a way that the statistician does not know which group the data belongs to in order to eliminate the bias. 3 Condition 1: methamphetamine dependents. Condition 2: heroin dependents. Intervention 1: Intervention group:Methadon meintenance therapy adjuctive temprament-based psychopharmacotherapy with 5-10 mg olanzapine orally daily .In this group, people are treated with methadone with a dose determined by the clinisiane in charge of the clinic based on the national protocol, and this dose is from 40 to 60 mg. In the mornings, this dose is given to him in the form of methadone syrup through the clinic, and along with it, he is treated with 5 mg Elanzapine tablets in each unit of the second generation antipsychotic drugs with a dose of 5 to 10 mg based on the discretion of the relevant psychiatric assistant. It starts from Subhan company and is given to him for one month in the number of 30 to 60 pieces according to the prescribed amount. Intervention 2: Control group: Methadon meintenance therapy.ln this group: methadone therapy. This group is treated with methadone syrup at a dose of 40 to 60 mg per day according to the discretion of the clinisiane in charge of the addiction treatment clinic, and this dose is determined based on the national protocol of methadone maintenance treatment. And for one week, the total dose It is given to the patient in the form of syrup, and the patient returns weekly to receive the next doses. Yes - There is a plan to make this available What will be shared: All data can be shared. When: Since 1403 To whom: Medical students Conditions: Scientific and therapeutic use is unimpeded. Where to obtain: You can contact Dr. Akram Rasti Barzaki located in AmirKabir Arak Medical Center with mobile number 09188487448. How to obtain: 3 months Comments:
public Rastibarzoki Akram
Behdari St.Niyayesh4
Arak Iran (Islamic Republic of) 3815646914 +98 86 3313 7948 akrmrastybrzky@gmail.com Arak University of Medical Sciences scientific Dr Nokani,Mostafa
Amirkabir Hospital
Arak Iran (Islamic Republic of) 381963181 +98 86 3313 2510 Hajinokani@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Consent to participate in the study All dependent patients on heroin and meth-amphetamine Having Novelty seeking temperament Age 18 to 45 years Having desire to methadone maintenance treatment 18 years 45 years Both Having past history of medical complication after use antipsychotic Having past history of Renal and liver disease Having past history of Heart disease T43.625 T40.1 Adverse effect of amphetamines Poisoning by and adverse effect of heroin Treatment - Drugs Treatment - Drugs Intervention group:Methadon meintenance therapy adjuctive temprament-based psychopharmacotherapy with 5-10 mg olanzapine orally daily .In this group, people are treated with methadone with a dose determined by the clinisiane in charge of the clinic based on the national protocol, and this dose is from 40 to 60 mg. In the mornings, this dose is given to him in the form of methadone syrup through the clinic, and along with it, he is treated with 5 mg Elanzapine tablets in each unit of the second generation antipsychotic drugs with a dose of 5 to 10 mg based on the discretion of the relevant psychiatric assistant. It starts from Subhan company and is given to him for one month in the number of 30 to 60 pieces according to the prescribed amount. Control group: Methadon meintenance therapy.ln this group: methadone therapy. This group is treated with methadone syrup at a dose of 40 to 60 mg per day according to the discretion of the clinisiane in charge of the addiction treatment clinic, and this dose is determined based on the national protocol of methadone maintenance treatment. And for one week, the total dose It is given to the patient in the form of syrup, and the patient returns weekly to receive the next doses. Boredom. Timepoint: 6 months. Method of measurement: Boredom questionnaire. Relapse. Timepoint: 6 months. Method of measurement: Urine anlysis. Arak University of Medical Sciences Approved 2022-09-11 Ethics committee of Arak University of Medical Sciences Sardasht St Arak Markazi Iran (Islamic Republic of)