Moderate to severe opioids use disorder. Opioid dependence
Conditions
Interventions
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
Sponsors
Faran Shimi Pharmaceutical Company
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of negative morphine urine tests. Timepoint: Baseline assessment and then weekly during study. Method of measurement: Rapid morphine urine test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Retention in treatment. Timepoint: Baseline assessment and then weekly during study. Method of measurement: Continuous referrals to receive study medications and physician's visit. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAlireza Noroozi
Tehran University of Medical Sciences
Outcome results
None listed