Opioid use disorder. Opioid dependence
Conditions
Interventions
Intervention 1: Intervention group: withdrawal management with oral naltrexone. In this group, the withdrawal management program, or detoxification, lasts for 7 days. On the first day, patients are in
Sponsors
Tehran University of Medical Sciences
Nano Daru Pharmaceutical
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: A current diagnosis of moderate to severe opioid use disorder based on DSM-V Age between 18 and 60 years Residency in Tehran A minimum of 3 months of continuous opioid use Positive urine test for morphine, tramadol, methadone, or buprenorphine Ability to provide written informed consent No severe or acute medical or psychiatric disorders No physiological dependence on alcohol or sedative-hypnotic drugs No history of opioid overdose in the past 3 years Not receiving opioid-based medications (e.g., oxycodone) for chronic pain management No regular use of methadone or buprenorphine (not undergoing methadone or buprenorphine maintenance therapy) Not pregnant or breastfeeding No history of allergy or hypersensitivity to naltrexone or components of XR-NTX No known hypersensitivity to poly lactide-co-glycolide, carboxymethyl cellulose, or any diluent agents
Exclusion criteria
Exclusion criteria: Impaired liver function enzymes Coagulation disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Injection of the First Dose of Extended-Release Naltrexone. Timepoint: The primary outcome will be measured on day 8 after the start of the study in the oral naltrexone withdrawal management group and on day 15 in the sublingual buprenorphine withdrawal management group. Method of measurement: By direct observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Craving Intensity. Timepoint: In the oral naltrexone group, at the beginning of the study (before the intervention) and on days 2, 3, 4, 5, 6, 7, and 8 after the start of the intervention. In the sublingual buprenorphine group, at the beginning of the study (before the intervention) and on days 2, 3, 4, 5, 6, 7, and 15 after the start of the intervention. Method of measurement: Visual Analogue Scale.;Experienced Clinical Withdrawal Symptoms. Timepoint: In the oral naltrexone group, at the beginning of the study (before the intervention) and on days 2, 3, 4, 5, 6, 7, and 8 after the start of the intervention. In the sublingual buprenorphine group, at the beginning of the study (before the intervention) and on days 2, 3, 4, 5, 6, 7, and 15 after the start of the intervention. Method of measurement: Clinical Opiate Withdrawal Scale.;Experienced Subjective Withdrawal Symptoms. Timepoint: In the oral naltrexone group, at the beginning of the study (before the intervention) and on days 2, 3, 4, 5, 6, 7, and 8 after the start of the intervention. In the sublingual buprenorphine group, at the beginning of the study (before the intervention) and on days 2, 3, 4, 5, 6, 7, and 15 after the start of the intervention. Method of measurement: Subjective Opiate Withdrawal Scale.;Retention in Treatment. Timepoint: In the oral naltrexone group, on days 2, 3, 4, 5, 6, 7, and 8 after the start of the intervention. In the sublingual buprenorphine group, on days 2, 3, 4, 5, 6, 7, and 15 after the start of the intervention. Method of measurement: By direct observation.;Safety. Timepoint: In the oral naltrexone group, on days 2, 3, 4, 5, 6, 7, and 8 after the start of the intervention. In the sublingual buprenorphine group, on days 2, 3, 4, 5, 6, 7, and 15 after the start of the intervention. Method of measurement: By asking an open-ended question: "In addition to the experienced withdrawal symptoms, have you experienced any other specific adverse effects?". | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeede Jafari
Tehran University of Medical Sciences
Outcome results
None listed