Benzodiazepine withdrawal and craving MedDRA version: 20.0 Level: PT Classification code 10033329 Term: Oxytocin System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Syntocinon
Product Name: Syntocinon
Pharmaceutical Form: Nasal spray, suspension
Pharmaceutical form of the placebo: Nasal spray
Route of administration of the placebo: Intranasal use (Non
Sponsors
St. Olav's University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 – 65 years, taking BZDs at a daily dose of 20-80 mg diazepam-equivalent, and requiring inpatient BZD withdrawal. Included patients must consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Female patients will be excluded if they are pregnant or are planning to become so, or if they are breast-feeding. Individuals incapable of completing questionnaires or giving informed consent will be excluded. Patients with concurrent acute medical or psychiatric illness requiring acute care hospitalization, misuse or dependency of alcohol or pregabalin/gabapentin will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the study is to test whether there is a difference between daily intranasal administration of oxytocin or placebo for 21 days added to a dose reduction regime of diazepam in benzodiazepine withdrawal symptoms. Benzodiazepine withdrawal symptoms severity is measured with CIWA-B score, a 20-item scale where each item can be assigned a score from 0 to 4, i.e. the total score can range from 0 and 80 points. CIWA-B score will be measured daily from baseline (i.e. the day before the intervention starts) to day 21. Change in CIWA-B from baseline to day 21 will compared between the two groups. ;Secondary Objective: The secondary aims are to test whether there is a difference between oxytocin and placebo on cravings (measured daily with a 6-item Likert scale where the score can range between 0 to 5 points between the two study groups from baseline to day 21), on rebound anxiety and depression symptoms (comparing HAD scores measured weekly from baseline to day 21), on sleep (assessed by actigraphy and Somnofy), number of "freezes" in diazepam tapering (number of times not reducing the diazepam dosage as scheduled).;Primary end point(s): 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. The Clinical Institute Withdrawal Assessment Scale for Benzodiazepines (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 points and 80 points. Three items are considered objective measurements in which they are reviewed by health personnel. Few previous studies have been conducted with the use of the CIWA-B scale. What score can be considered of clinical interest is therefore based upon the results from previous studies using CIWA-B as a measurement for benzodiazepine withdrawal sym | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Hamilton Anxiety and Depression Scale (HAD), Insomnia Severity Index (ISI) and actigraphy and Somnofy assessed akathisia and sleep.;Timepoint(s) of evaluation of this end point: After completed 4 weeks inpatient stay (day 21 of intervention period). | — |
Countries
Norway
Contacts
Public ContactPI's representative (Tone Pleym)
Lade Addiction Treatment Center
Outcome results
None listed