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Suboxone treatment and recovery trial

Optimizing opioid assisted therapy : personalizing treatment using therapeutic drug monitoring and medication management

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41645723
Enrollment
144
Registered
2016-08-07
Start date
2014-09-01
Completion date
Unknown
Last updated
2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid use disorders (prescription opioids and illicit opiates) Mental and Behavioural Disorders

Interventions

Inpatient phase (4 weeks): Participants using illicit opioid dependence will receive a 3-day BNX-F dose induction
those using prescription opioid use will receive a 5-day induction. This is followed by a 14-day dose stabilisation (patients allocated to daily, alternate day or thrice weekly dosing regimens) accord

Sponsors

National Rehabilitation Center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Males and females aged 18- 64 years 2. Diagnosed with current opioid use disorder (ICD-10) 3. Current use of street heroin and/or pharmaceutical opioid 4. Able to comprehend instructions and consent to the trial participation 5. Voluntarily seeking treatment 6. Able to be discharged to stable accommodation

Exclusion criteria

Exclusion criteria: 1. Pregnant 2. Patients with known hypersensitivity to naloxone or buprenorphine 3. Hepatic Impairment (>3 times elevated liver function) 4. Any prior suicidal attempt and current active suicide plan 5. Involvement in current criminal justice proceedings 6. Active uncontrolled severe mental illness or evidence of organic brain disease that is judged by clinical director to compromise patient safety 7. Acute and severe respiratory illness 8. Paralytic ileus 9. Benzodiazepine use (in the past 28 days) in excess of 20 mg daily diazepam equivalent ,2

Design outcomes

Primary

MeasureTime frame
Mean % of UDS negative tests for opioid class.

Secondary

MeasureTime frame
1. Mean % of patients completing study period (retention) 2. Mean change in the following clinical parameters (depression, anxiety, impulsiveness, addiction severity index (ASI), work and social adjustment

Countries

United Arab Emirates

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026