Feasibility of Opioid Injectable Treatment

Phase 4

Active, not recruiting

• Conditions: Opioid Use Disorder; Mental Health - Addiction

• Registration Number: ACTRN12621001729819
• Lead Sponsor: St Vincent's Hospital Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-17
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Participants should:
1. aged 21-60 years
2. have minimum 5 years opioid dependence, and current physical opioid dependence as assessed using ICD-10 criteria
3. had previous access to treatment
4. currently injecting opioids > 3 times weekly
5. have evidence of harm (self-reported crime, or comorbid health or mental health conditions, impaired social functioning)
6. have ability to provide written, informed consent to participate as assessed by trial medical staff

Exclusion Criteria

1. pregnant, breastfeeding, or planning to become pregnant (participants at risk of pregnancy should avoid pregnancy while receiving study treatment; participants who become pregnant will be transferred to oral Opioid Agonist Therapy [OAT])
2. advanced liver disease (Childs-Pugh B)
3. chronic airflow limitation or other respiratory compromise producing dyspnoea on mild exertion
4. other severe and active medical condition as assessed by study medical officer
5. requires prescribed medication which interacts with trial medication in ways which make treatment unsafe
6. severe psychiatric disorder at the time of assessment (e.g. acute psychosis, severe anxiety and/or mood disorder, intent to harm self or others assessed by study medical officer and/or psychiatrist).
7. severe cognitive impairment making it difficult for person to complete study requirements
8. previous adverse reaction to hydromorphone
9. concurrent monoamine oxidase inhibitors (MAOIs), or within 14 days of treatment with MAOIs
10. inability to provide informed consent, even with a registered medical interpreter

Study & Design

• Study Type: Interventional
• Study Design: Not specified