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IRCT20090801002266N12 IRCT 2020-03-17 Esfarayen University of Medical Sciences buprenorphine efficacy in methamphetamin dependency Efficacy of add on buprenorphine vs. placebo on reduction of relapse among people with Met Amphetamine dependency during Matrix program 2019-08-23 anticipated 40 Complete https://irct.ir/trial/41171 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Given the sample size of 40 people, Sampling will be done in ten blocks of four, In each block, two individuals will be randomly assigned to the intervention group and two to the control group, so that all six states of a four-block may be selected ten times randomly from the six blocks. By the end, twenty people in each group will be randomly assigned blocks, Blinding description: Participants in the study did not know whether they would take the drug placebo. Principal investigators are also blinded to this, and the drug and placebo are provided in code-packs by the person who is not directly involved in the study. People who are evaluating and recording the study outcomes are also unaware that the patient has received the drug or the placebo. 3 Methamphetamine use disorder. Intervention 1: Intervention group: buprenorphine In the intervention group, buprenorphine will be started in a sublingual form (made by Mehr Pharmaceutical Company) at a dose of 2 mg daily and increased to 4 mg daily (2 sublingual tablets) over a 7-day period and continued for 1 month. And then gradually discontinue within 2 weeks. Patients will be evaluated by urine methamphetamine test and CCQ-Brief questionnaire at the time of each week during intervention and after the 1 month in follow-up period. Intervention 2: Control group: placebo In the control group, placebo with the same form as buprenorphine (prepared by the Faculty of Pharmacy) would be used in sublingual and with a similar protocol to the intervention group for up to 1 month. and similar to the intervention group they would be assessed with a urine amphetamine test and a CCQ-Brief questionnaire weekly at the time of intervention and monthly during the follow-up period. No - There is not a plan to make this available Justification or reason for not sharing IPD is there are no more data
public Gholamreza Kheirabadi
Khorshid Hospital, Ostandari St. Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81458-31451 +98 31 3222 2135 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences scientific gholamreza kheirabadi
Behavioral Sciences Research Center, Khorshid hospitalm, Ostandari St, Isfahan, iran
Esfahan Iran (Islamic Republic of) 8145831451 +98 31 3222 2135 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 1) People 18-60 years old 2)Having the DSM-V criteria for methamphetamine use disorder 3) It is dependent only on methamphetamine 4) No pregnancy and lactation 18 years 60 years Both 1)Any psychiatric disorder that require hospitalization 2) Medical condition that interfere with participating in the study 3)Any side effect that interfere with continuation of buprenorphin F10-F19 Mental and behavioral disorders due to use of other stimulants, including caffeine Treatment - Drugs Placebo Intervention group: buprenorphine In the intervention group, buprenorphine will be started in a sublingual form (made by Mehr Pharmaceutical Company) at a dose of 2 mg daily and increased to 4 mg daily (2 sublingual tablets) over a 7-day period and continued for 1 month. And then gradually discontinue within 2 weeks. Patients will be evaluated by urine methamphetamine test and CCQ-Brief questionnaire at the time of each week during intervention and after the 1 month in follow-up period Control group: placebo In the control group, placebo with the same form as buprenorphine (prepared by the Faculty of Pharmacy) would be used in sublingual and with a similar protocol to the intervention group for up to 1 month. and similar to the intervention group they would be assessed with a urine amphetamine test and a CCQ-Brief questionnaire weekly at the time of intervention and monthly during the follow-up period Substance use craving. Timepoint: weeks 1-8 and 12,16,20,and 24. Method of measurement: questionair. Esfarayen University of Medical Sciences Approved 2019-07-28 etic commeettee of Isfahan University of Medical Sciences vicechancelor for research , Isfahan University of Medical Sciences, Hezarjerib St. Isfahan Iran Isfahan Isfehan Iran (Islamic Republic of)