Benzodiazepine dependence (F13.2)
Conditions
Brief summary
The primary endpoint of the study is measuring BZD withdrawal symptoms to see if OT administered intranasally in addition to traditional dose tapering is more effective than BZD tapering and placebo. CIWA-B is a well-known and well-used 20-item questionnaire for BZD withdrawal symptoms where each item can be assigned a score from 0 to 4, i.e. the total score can range between 0-80 points. Based on previous studies a 3.5-point difference is considered clinically relevant.
Detailed description
Hamilton Anxiety and Depression Scale (HAD), Insomnia Severity Index (ISI) and actigraphy and Somnofy assessed akathisia and sleep.
Interventions
Sponsors
St. Olavs Hospital HF
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is measuring BZD withdrawal symptoms to see if OT administered intranasally in addition to traditional dose tapering is more effective than BZD tapering and placebo. CIWA-B is a well-known and well-used 20-item questionnaire for BZD withdrawal symptoms where each item can be assigned a score from 0 to 4, i.e. the total score can range between 0-80 points. Based on previous studies a 3.5-point difference is considered clinically relevant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety and Depression Scale (HAD), Insomnia Severity Index (ISI) and actigraphy and Somnofy assessed akathisia and sleep. | — |
Countries
Norway
Outcome results
None listed