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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
| Lade Behandlingssenter, Blå Kors | UNKNOWN |
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The goal of this clinical trial is to learn if oxytocin administered as a nasal spray will reduce withdrawal symptoms in adults during benzodiazepine tapering for 21 days. It will also learn about the safety of oxytocin. The main question it aims to answer are:
Does oxytocin reduce benzodiazepine withdrawal symptoms and make it easier to succeed tapering? Does oxytocin help reduce sleep difficulties and anxiety or restlessness during benzodiazepine tapering? Does oxytocin help reduce benzodiazepine craving?
We will compare oxytocin nasal spray to a placebo nasal spray containing regular saline to see if oxytocin works accordingly.
Participants will:
Take oxytocin or a placebo nasalspray, thrice daily for 21 days during inpatient benzodiazepine tapering.
Fill out an online questionnaire every day and keep a record of their symptoms.
Background Benzodiazepine withdrawal can be challenging, often accompanied by severe anxiety, insomnia, and other withdrawal symptoms. Recent studies suggest that intranasal oxytocin (OT) may have anxiolytic properties and could potentially ease withdrawal symptoms. This pilot study aims to evaluate the efficacy and safety of intranasal OT in the treatment of benzodiazepine withdrawal.
Objectives The primary objective is to evaluate if intranasal OT can reduce withdrawal symptoms in patients during benzodiazepine tapering. Secondary objectives include evaluating the safety and tolerability of intranasal OT and its impact on anxiety levels and sleep quality.
Methods
Procedure
Expected Outcomes It is hypothesized that participants receiving intranasal OT will experience a significant reduction in withdrawal symptoms compared to the placebo group. Improvements in anxiety levels and sleep quality are also anticipated.
Significance This study could provide preliminary evidence for the use of intranasal OT as a supportive treatment for benzodiazepine withdrawal, potentially improving patient outcomes and comfort during the tapering process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants in the placebo arm will receive a saline solution. Saline is an inert substance, meaning it has no therapeutic effect, making it an ideal placebo. The saline solution will be administered in the same manner as the experimental treatment. The treatment is administered intranasally. The treatment is blinded. Neither the participants nor the researchers know who is receiving the placebo and who is receiving the active treatment. Participants in the placebo arm will be monitored the same as those in the treatment arm. Participants will be fully informed about the possibility of receiving a placebo and will provide informed consent. The same outcome measures will be used for both the placebo and treatment arms. |
|
| Oxytocin | Experimental | Participants in this arm will receive intranasal oxytocin. The dosage and administration schedule will be consistent with the study protocol. Participants will receive 48 international units (IU) of oxytocin. The oxytocin will be administered intranasally using a nasal spray. Participants will insert the nasal spray container approximately 1 cm into each nostril and spray. They will wait 15 seconds before repeating administration until they have received a total of 4 puffs (2 in each nostril) per session thrice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin nasal spray | Drug | Syntocinon contains synthetic oxytocinfor intranasal use, 6.7 microg (4 IU) per dose. We are planning to use 4 insufflations (16 IU) three times daily (i.e. a total daily dose of 48 IU). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Benzodiazepine craving | To test whether there is a difference between oxytocin and placebo on cravings. Comparing cravings scores 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. Specifically, the change in scores from baseline to day 21 will compared between the two groups. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up: Relapse | To test whether there is a difference between oxytocin and placebo in time to first benzodiazepine intake (up to 12 weeks after discharge). Comparing time (number of days) to first self-reported benzodiazepine intake after discharge (week 3) between the two study groups, by registration on the follow-up visits at week 7 and week 15. | 15 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tone Aurora Pleym, MD, PhD-candidate | Contact | +47 97 62 55 83 | tone.pleym@ntnu.no | |
| Olav Spigset MD, Professor of Clinical Pharmacology | Contact | +47 725 73 000 | olav.spigset@legemidler.no |
| Name | Affiliation | Role |
|---|---|---|
| Tone Aurora Pleym, MD, PhD-candidate | NTNU, Blue Cross, Clinic Lade, St. Olavs hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blue Cross, Clinic Lade | Recruiting | Trondheim | Trøndelag | 7091 | Norway |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Saline (NaCl 0,9 %) (placebo) | Drug | Saline intranasal placebo comparator |
|
| Benzodiazepine anxiety and depression symptoms | To test whether there is a difference between oxytocin and placebo on rebound anxiety and depression symptoms. Comparing Hospital Anxiety and Depression rating scale (HAD) scores measuring psychological distress, anxiety and depression between the two study groups measured weekly from baseline to day 21. Specifically, the change in scores from baseline to day 21 will compared between the two groups. | 21 days |
| Benzodiazepine sleep distress | To test whether there is a difference between oxytocin and placebo on sleep. Comparing Insomnia Severity Index (ISI) scores measuring sleep difficulties, and sleep variables assessed by actigraphy and Somnofy, between the two study groups from baseline to day 21 during intervention. | 21 days |
| Benzodiazepine tapering "freezes" | To test whether there is a difference between oxytocin and placebo in the number of "freezes" in diazepam tapering. A "freeze" (not reducing the diazepam dose as scheduled during tapering) will be noted for each subject and compared between the two study groups. | 21 days |
| Follow-up: Benzodiazepine withdrawal symptoms | Difference between oxytocin and placebo group on withdrawal symptoms measured with CIWA-B at week 7 and week 15 after discharge. | 15 weeks |
| Follow-up: Benzodiazepine craving | To test whether there is a difference between oxytocin and placebo on cravings. Comparing cravings scores measured at week 7 and week 15 after discharge 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. | 15 weeks |
| Follow-up: Benzodiazepine anxiety and depression symptoms | To test whether there is a difference between oxytocin and placebo on rebound anxiety and depression symptoms at week 7 and week 15 after discharge. Comparing Hospital Anxiety and Depression rating scale (HAD) scores measuring psychological distress, anxiety and depression between the two study groups. | 15 weeks |
| Follow-up: Benzodiazepine sleep distress | To test whether there is a difference between oxytocin and placebo on sleep distress at week 7 and week 15 after discharge. Comparing Insomnia Severity Index (ISI) scores measuring sleep difficulties. | 15 weeks |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |