Diazepam for Benzodiazepine dependence | Opioid dependence

Inclusion criteria

• {"criterion_text":"- Adult age (≥ 18 years)\n- Opioid dependence according to ICD-10, and ongoing OAT\n- Benzodiazepine dependence according to ICD-10 under the following conditions: Minimum duration is the last 5 years Use 5-7 days a week during the last month Minimum dose used is equivalent to 15 mg diazepam/d or higher [21] Previous attempts with outpatient or inpatient tapering of benzodiazepines Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol The eligibility will be determined by clinical assessment with a medical doctor"}

Exclusion criteria

• {"criterion_text":"- Severe respiratory failure (GOLD 3-4)\n- High risk of violent behavior (current violence episodes i.e., during the last 6 months)\n- High risk of substance related overdose (current overdoses i.e., during the last 6 months)\n- Severe cognitive impairment (IQ<70; assessed if needed based on clinical decision)\n- Severe psychosis (current psychotic symptoms and functioning i.e., during the last 6 months based on clinical decision)\n- Severe depression and high suicide risk (current episodes i.e., during the last 6 months based on clinical decision)\n- Patients who are already being stabilized with prescribed continuous benzodiazepines\n- Pregnancy and breastfeeding (It is a requirement that female participants use a safe method of contraception. In doubtful cases, a negative pregnancy test will be required)\n- Challenges related to ability to understand, consent, or willingness to collaborate in following-up of the study and its protocol"}

Primary endpoints

• {"endpoint_text":"- The main endpoint is difference in the illegal index which measures the use of illicit benzodiazepines (as assessed by weekly or monthly supervised urinary tests) at week 24 compared to baseline. The illegal index is defined as the proportion of positive tests and is considered continuous.","definition_or_measurement_approach":"Measured by weekly or monthly supervised urinary tests; the 'illegal index' is defined as the proportion of positive tests and treated as a continuous variable; comparison at week 24 vs baseline."}

Secondary endpoints

• {"endpoint_text":"- Differences between the two study arms (baseline compared to week 24 in terms of: Mental health symptoms score using Hopkins symptom check list (SCL-10)","definition_or_measurement_approach":"Measured by Hopkins Symptom Checklist (SCL-10) score change from baseline to week 24."}
• {"endpoint_text":"- Difference between the two study arms (baseline compared to week 24 in terms of: Reaction time (https://www.justpark.com/creative/reaction-time-test/)","definition_or_measurement_approach":"Measured by reaction time test (link provided); comparison of baseline to week 24."}
• {"endpoint_text":"- Differences between the two study arms (baseline compared to week 24 in terms of: Health related quality of life score using EQ-5D-5L","definition_or_measurement_approach":"Measured by EQ-5D-5L health-related quality of life score change from baseline to week 24."}
• {"endpoint_text":"- Differences between the two study arms in terms of: Satisfaction with the treatment using Visual Analogue Scale (VAS)","definition_or_measurement_approach":"Measured by Visual Analogue Scale (VAS) for treatment satisfaction; comparison between arms."}
• {"endpoint_text":"- Differences between the two study arms in terms of: Retention rate in OAT (days in treatment during the study period)","definition_or_measurement_approach":"Retention measured as days in opioid agonist therapy (OAT) during the study period."}
• {"endpoint_text":"- Differences between the two study arms in terms of: Use of other illicit substances (stimulants, opioids, cannabis) and alcohol, based on urinary tests and self-reports, and illicit benzodiazepines based on self-reports","definition_or_measurement_approach":"Measured by urinary tests and self-reports for other substances and alcohol; illicit benzodiazepine use also assessed by self-report."}
• {"endpoint_text":"- Differences between the two study arms in terms of: Violent behaviour and threats on violence, based on Brøset Violence checklist score (BVC)","definition_or_measurement_approach":"Measured by Brøset Violence Checklist (BVC) score; comparison between arms."}
• {"endpoint_text":"- Differences between the two study arms in terms of: Numbers of non-fatal overdose and death (if any)","definition_or_measurement_approach":"Count of non-fatal overdoses and deaths during study period; comparison between arms."}

Norway

Earliest CTIS Part Ii Submission Date

03-10-2024

Latest Decision Or Authorization Date

07-07-2025

Processing Time Days

277

Number Of Sites

6

Number Of Participants

108

Primary sponsor

Full Name

Helse Bergen HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway