A new clinical trial is underway to evaluate two distinct approaches for managing benzodiazepine dependence in patients receiving opioid agonist treatment (OAT). The study, being conducted across six OAT clinics, compares a novel stabilization strategy against the current standard tapering protocol.
Treatment Protocol Design
The intervention arm will receive stabilizing agonist treatment with either diazepam (15-30 mg/day) or oxazepam (50-100 mg/day) over 26 weeks. In contrast, the control group will undergo the standard tapering protocol with the same medications over a maximum of 20 weeks, following current Norwegian OAT guidelines.
Medication choice between diazepam and oxazepam will be individualized based on several factors, including patient preferences, medical history, and current health status. Starting doses will be determined by considering the degree of dependence, previous illicit benzodiazepine use, and individual clinical conditions.
Comprehensive Monitoring and Safety Measures
The trial implements rigorous safety protocols and monitoring procedures. Participants will receive frequent clinical observations during the first two weeks of treatment to ensure safety. Regular follow-up includes:
- Weekly monitoring by OAT staff or research nurses
- Monthly randomized urine drug screening
- Assessment of medication adherence through prescription pickup frequency
- Self-reported compliance measures
- Systematic reporting of potential adverse effects
Outcome Measurements
The study will evaluate multiple outcomes at baseline and week 24, including:
- Mental health symptoms using the Hopkins symptom checklist
- Health-related quality of life via EQ-5D-5L questionnaire
- Cognitive performance through reaction time testing
- Risk of violent behavior assessment
- Treatment satisfaction ratings
- OAT retention rates
- Frequency of alcohol and illicit substance use
- Occurrence of non-fatal overdoses
- Cost-effectiveness analysis
Statistical Power and Recruitment
The trial aims to enroll 108 participants, with 54 in each arm, accounting for an anticipated 20% dropout rate. This sample size was calculated to detect a minimal clinically relevant difference of 0.3 between groups in illicit benzodiazepine use, with 80% power at a two-sided significance level of 0.05.
Post-Trial Care Considerations
Following the 26-week intervention period, participants will undergo individual clinical assessments to determine appropriate ongoing care. Some participants in the stabilization arm may continue their prescribed regimen, while others may transition to supervised tapering, based on their clinical outcomes and individual needs.
The study represents a significant step forward in understanding optimal treatment approaches for benzodiazepine dependence in OAT patients, with potential implications for future clinical practice guidelines and patient care protocols.
