Medical condition: Adults enrolled in OAT (Opioid Agonist Treatment) with DSM-5-diagnosed substance (benzodiazepine) use disorder with toxicologically verified non-prescription benzodiazepine use in the previous month. Medical condition in lay language: Adults who are enrolled in Opioid Agonist Treatment programme (methadone or buprenorphine) who are using non-prescribed (street) benzodiazepine. Therapeutic areas: Psychiatry and Psychology [F] - Behaviours [F01] Mental and Behavioural Disorders
Conditions
Interventions
An online tool will randomly assign In-BOAT participants to either the diazepam maintenance intervention (a maintenance maximum daily dose of 30mg diazepam with tailored psychosocial support) or Stand
Sponsors
University of Stirling
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 and over enrolled in OAT who are clinically stable on OAT (methadone or buprenorphine) 2. With toxicologically verified non-prescription benzodiazepine use in the previous month 3. With DSM-5-diagnosed substance (benzodiazepine) use disorder 4. At risk of harm from street benzodiazepine use. Risk of harm is defined as regular use of unregulated street benzodiazepines, overdose (defined as ambulance call or emergency department attendance) or reported binge use (defined as black-out/loss of memory)
Exclusion criteria
Exclusion criteria: 1. Co-occurring alcohol dependence 2. Already prescribed a benzodiazepine or have had a benzodiazepine prescription in the previous month 3. Current pregnancy or breastfeeding 4. Non-English speaking 5. Diagnosed with severe mental illness or severe cognitive impairment 6. Contraindications with diazepam therapy 7. Inability or incapacity to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of positive tests for street benzodiazepines as determined by toxicology via monthly oral fluid testing (or urine if preferred by patient), in a 12-month period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Substance use over the previous month, including compensatory substance use (drugs and alcohol); high dose and polydrug use; heavy drinking days; days of abstinence; drug use trajectory over time; overdose requiring emergency care (naloxone, ambulance or emergency department attendance or hospital admission) measured using bespoke questions capturing participant self-report, at Baseline and monthly for 12 months 2. Resource use (including ambulance calls, hospital admissions, accident and emergency primary care and outpatient clinics, social work appointments) measured using bespoke questions capturing participant self-report, at Baseline and monthly for 12 months 3. Adverse events capturing participant self-report and any events documented in their case notes, monthly for 12 months 4. Retention in treatment, changes to prescribed medication, including OAT dose, and engagement with treatment measured using bespoke questions capturing participant self-report, impression of site researcher and data extracted from medical notes, monthly for 12 months 5. Demographics, Health, occupational and education status, social circumstances measured using bespoke questions capturing participant self-report, at Baseline and 12 months 6. Mental health (anxiety and depression); Cognition and memory; Participant-reported improvement and recovery; Quality of life; Satisfaction with treatment; GAD-7, PHQ-9, ACEIII, SURE, EQ-5D-5L and TPQ questionnaires; at Baseline (apart from TPQ), 6 months and 12 months timepoint 7. Cost-effectiveness, in terms of the incremental cost per quality-adjusted life year, and cost-consequences measured using analysis based on data captured under ‘Resource used’ | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactChristine Kennedy
Outcome results
None listed