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IRCT20170702034844N7 IRCT 2020-08-16 Faran Shimi Pharmaceutical Company Comparison of opioid maintenance treatments (OMTs) in prison Comparison of buprenorphine and methadone maintenance treatments in prison: a randomized controlled trial 2020-09-05 anticipated 100 Complete https://irct.ir/trial/48991 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random codes are created by the person responsible for data randomization using the website www.sealedenvelope.com. Patients are randomly allocated to one of two study arms including sublingual buprenorphine plus placebo syrup and sublingual placebo plus methadone syrup based on random sequence blocks with block size of 4. The codes created by the person responsible for the randomization, are attached to the medications of study groups, and each patient's code is given to the treatment provider in a sealed envelope, consecutively, Blinding description: Due to the different formulations of buprenorphine and methadone, for blinding, patients in intervention group will receive sublingual buprenorphine tablets and placebo syrup and patients in control group will receive placebo sublingual tablets and methadone syrup. The study is blind, meaning that the patient, therapists, and the statistical analyst will be unaware of the allocation group. 3 Moderate to severe opioids use disorder. Intervention 1: Intervention group: Sublingual buprenorphine plus placebo syrup. In this study, each unit of sublingual tablet is equal to 2 mg buprenorphine or placebo and each unit of syrup is equal to 5 mg (1 cc) of methadone or placebo. All study active and placebo medications are manufactured by Faran Shimi Pharmaceutical Company. Treatment is initiated with sublingual buprenorphine up to 6 mg/day plus placebo syrup up to 6 cc in the first day. During first week, patient is visited 2 more times and patient' doses are increased up to 8 mg/day of sublingual buprenorphine plus up to 8 cc of placebo syrup, if needed. During weeks 2 to 24, patient is visited on weekly basis and patient's doses are increased up to 24 mg/day of buprenorphine plus 22 cc of placebo syrup, if needed. Intervention 2: Intervention group: Sublingual placebo plus methadone syrup. Treatment is initiated with methadone syrup up to 6 units per day plus sublingual placebo up to 3 units in the first day. During first week, patients are visited 2 more times and patient's doses are increased up to 8 units day of methadone syrup plus 4 units of sublingual placebo, if needed. During weeks 2 to 24, patient is visited on weekly basis and patient's doses are increased up to 22 units of methadone syrup plus up to 12 units of sublingual placebo, if needed. Yes - There is a plan to make this available What will be shared: It is planned to share IPD and report of the clinical study. When: IPD will be shared after completion of the data gathering phase. Report of the clinical study will be finalized at the end of study . To whom: Clinical researchers Conditions: IPD will be available for researchers who are conducting review studies. Study report will be published as English article. Where to obtain: Email to the individual who is responsible for scientific inquiries of this project How to obtain: It will be responded after processing within the project team. Comments:
public Alireza Noroozi
No 486, South Kargar St., Qazvin Sq.
Tehran Iran (Islamic Republic of) 1336616357 +98 21 5542 1144 a_r_noroozi@yahoo.com Tehran University of Medical Sciences scientific Alireza Noroozi
No 486, South Kargar St., Qazvin Sq.
Tehran Iran (Islamic Republic of) 1336616357 +98 21 5542 1144 a_r_noroozi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of moderate to severe opioid use disorder based on DSM-5 Continuous consumption of illegal opioids in the past month prior to incarceration Age 18 to 50 years Informed written consent to enter the study Conviction period more than 6 months 18 years 50 years Male Concurrent diagnosis of other substance use disorders (except tobacco) Uncontrolled severe psychiatric disorders including serious suicidality or psychosis based on a study physician's diagnosis Severe and uncontrolled physical conditions including unstable angina, liver failure and a history of myocardial infarction during last month based on physician' s diagnosis and laboratory evaluations Inability to understand the study protocol or respond to study assessments More than three times raise of liver enzymes F11.2 Opioid dependence Treatment - Drugs Treatment - Drugs Intervention group: Sublingual buprenorphine plus placebo syrup. In this study, each unit of sublingual tablet is equal to 2 mg buprenorphine or placebo and each unit of syrup is equal to 5 mg (1 cc) of methadone or placebo. All study active and placebo medications are manufactured by Faran Shimi Pharmaceutical Company. Treatment is initiated with sublingual buprenorphine up to 6 mg/day plus placebo syrup up to 6 cc in the first day. During first week, patient is visited 2 more times and patient' doses are increased up to 8 mg/day of sublingual buprenorphine plus up to 8 cc of placebo syrup, if needed. During weeks 2 to 24, patient is visited on weekly basis and patient's doses are increased up to 24 mg/day of buprenorphine plus 22 cc of placebo syrup, if needed. Intervention group: Sublingual placebo plus methadone syrup. Treatment is initiated with methadone syrup up to 6 units per day plus sublingual placebo up to 3 units in the first day. During first week, patients are visited 2 more times and patient's doses are increased up to 8 units day of methadone syrup plus 4 units of sublingual placebo, if needed. During weeks 2 to 24, patient is visited on weekly basis and patient's doses are increased up to 22 units of methadone syrup plus up to 12 units of sublingual placebo, if needed. Proportion of negative morphine urine tests. Timepoint: Baseline assessment and then weekly during study. Method of measurement: Rapid morphine urine test. Retention in treatment. Timepoint: Baseline assessment and then weekly during study. Method of measurement: Continuous referrals to receive study medications and physician's visit. Tehran University of Medical Sciences Faran Shimi Pharmaceutical Company Tehran University of Medical Sciences Approved 2020-06-27 Ethic Committee of National Institute for Health Research, Tehran University of Medical Sciences No. 70, North Bozorgmehr St., Vesal Shirazi St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)