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IRCT20170702034844N3 IRCT 2018-02-16 Tehran University of Medical Sciences Efficacy of outpatient treatment of alcohol use disorder Efficacy and safety of outpatient alcohol treatment among people with alcohol use disorder referring to INCAS psychiatric clinic 2018-04-21 anticipated 31 Complete https://irct.ir/trial/26518 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Alcohol use disorder. All patient who meet study eligibility criteria will receive outpatient fixed-schedule alcohol withdrawal treatment with benzodiazepines (diazepam) for 1 to 3 weeks according to national alcohol treatment guidelines if needed (score of Severity of Alcohol Dependence Questionnaire between 15 and 30) and then entered to replace prevention pharmacotherapy with naltrexone 50 mg daily till end of week 12. Furthermore all patients will receive psychological interventions including structured weekly individual psychotherapy session on alcohol relapse prevention.. Yes - There is a plan to make this available What will be shared: Participants data file: The participants data without identifying information will be available after completion of the study. Clinical study report: The clinical study report will be available after completion of the study. When: July 2019 To whom: Researchers of psychiatric disorders clinical studies Conditions: Using study data for systematic reviews and meta-analysis studies ispermitted. Where to obtain: Dr. Alireza Noroozi Psychiatric Clinic, Iranian National Center for Addiction Studies (INCAS) Address: No 486, South Kargar St, Tehran, Iran Email: a_r_noroozi@yahoo.com How to obtain: The data request need to clearly define data needs. The study contact person will provide available data within 1 week after receiving the req Comments: NA
public Dr. Alireza Noroozi
No 486, South Kargar St., Qazvin Sq., Next to Farabi Hospital
Tehran Iran (Islamic Republic of) 1336616357 +98 21 5541 5225 a_r_noroozi@yahoo.com Tehran University of Medical Sciences scientific Dr.Alireza Noroozi
No 486, South Kargar St., Qazvin Sq., Next to Farabi Hospital
Tehran Iran (Islamic Republic of) 1336616357 +98 21 5541 5225 a_r_noroozi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age: 18 to 65 years old Diagnosis of alcohol use disorder based on DSM-5 Providing informed written consent 18 years 65 years Both Severe co-morbid psychiatric disorder including psychosis or suicide Inappropriate for outpatient treatment due to lack of family support, history of delirium tremens (DT) or seizures during previous alcohol withdrawal attempts Inappropriate for outpatient treatment due to severe alcohol dependence defined by score over 30 in SADQ test F10.2 A cluster of behavioural, cognitive, and physiological phenomena that develop after repeated substance use and that typically include a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences Treatment - Other All patient who meet study eligibility criteria will receive outpatient fixed-schedule alcohol withdrawal treatment with benzodiazepines (diazepam) for 1 to 3 weeks according to national alcohol treatment guidelines if needed (score of Severity of Alcohol Dependence Questionnaire between 15 and 30) and then entered to replace prevention pharmacotherapy with naltrexone 50 mg daily till end of week 12. Furthermore all patients will receive psychological interventions including structured weekly individual psychotherapy session on alcohol relapse prevention. Treatment retention. Timepoint: Weekly for 12 weeks. Method of measurement: Participation in weekly individual psychotherapy session. Alcohol use disorders screening. Timepoint: Baseline and weeks 4 and 12. Method of measurement: Alcohol Use Disorder Identification Test (AUDIT). Severity of alcohol dependence. Timepoint: Baseline and weeks 4 and 12. Method of measurement: Severity of Alcohol Dependence Questionnaire (SADQ). Alcohol addiction severity. Timepoint: Baseline and week 12. Method of measurement: Alcohol section of Addiction Severity Index (ASI). Aspartate Aminotransferase (AST). Timepoint: Baseline and weeks 4 and 12. Method of measurement: Blood test. Alanine Aminotransferase (ALT). Timepoint: Baseline and weeks 4 and 12. Method of measurement: Blood test. Gamma-Glutamyl Transferase (GGT). Timepoint: Baseline and weeks 4 and 12. Method of measurement: Blood test. Tehran University of Medical Sciences Approved 2018-01-08 Ethics Committee of Tehran University of Medical Sciences (TUMS), Vice-Chancellor for Research 6th Floor, Central Building of Tehran University of Medical Sciences (TUMS), Ghods St., Keshavarz Blv. Tehran, Iran, Islamic Republic Of Tehran Tehran Iran (Islamic Republic of)