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Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot RCT

ConditionBenzodiazepine Dependence
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSt. Olavs Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 - 65 years, taking benzodiazepines at a daily dose of 20-80 mg diazepam-equivalent, and requiring inpatient benzodiazepine withdrawal. Included patients must consent to participate in the study.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • Saline (NaCl 0,9 %) (placebo)

    Drug

    Saline intranasal placebo comparator

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: OxytocinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
21 days

Secondary outcomes

1

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.

Time frame
21 days
2

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.

Time frame
21 days
3

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.

Time frame
21 days
4

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.

Time frame
21 days

Other outcomes

1

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.

Time frame
15 weeks
2

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.

Time frame
15 weeks
3

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.

Time frame
15 weeks
4

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.

Time frame
15 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Olavs Hospital

Lead sponsor

Norwegian University of Science and Technology

Collaborator

Lade Behandlingssenter, Blå Kors

Collaborator

Source ClinicalTrials.gov
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