Clinical trial NCT06757517: Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot RCT
Official title: Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot Randomized Parallell Group Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Benzodiazepine Dependence
Keywords: intranasal oxytocin
oxytocin
benzodiazepines
benzodiazepine dependence
benzodiazepine withdrawal
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Lade Behandlingssenter, Blå Kors
First posted: 2025-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

* Design: This is a randomized, parallel-group, placebo-controlled trial.
* Participants: 60 adults (aged 18-65) who are undergoing benzodiazepine tapering.
* Intervention: Participants will be randomly assigned to receive either intranasal OT (24 IU) or a placebo, administered twice daily for four weeks.
* Assessments: Withdrawal symptoms will be measured using the Clinical Institute Withdrawal Assessment for Benzodiazepines (CIWA-B) scale. Anxiety levels will be assessed using the Hamilton Anxiety Rating Scale (HAM-A), and sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) and actigraphy recordings.

Procedure

1. Screening: Eligible participants will undergo a screening process, including medical history, physical examination, and baseline assessments.
2. Randomization: Participants will be randomly assigned to the OT or placebo group.
3. Treatment Phase: Participants will self-administer the nasal spray thrice daily for three weeks. Participants will fill out daily questionnaires to monitor symptoms and side effects. Weekly urine- and blood samples will be collected.
4. Post-Treatment Follow-Up: Participants will be assessed at the end of the treatment period and again four and twelve weeks post-treatment to evaluate the persistence of effects.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Benzodiazepine withdrawal symptoms
timeFrame: 21 days
Secondary outcomes:
measure: Benzodiazepine craving
timeFrame: 21 days
measure: Benzodiazepine anxiety and depression symptoms
timeFrame: 21 days
measure: Benzodiazepine sleep distress
timeFrame: 21 days
measure: Benzodiazepine tapering "freezes"
timeFrame: 21 days
Other outcomes:
measure: Follow-up: Relapse
timeFrame: 15 weeks
measure: Follow-up: Benzodiazepine withdrawal symptoms
timeFrame: 15 weeks
measure: Follow-up: Benzodiazepine craving
timeFrame: 15 weeks
measure: Follow-up: Benzodiazepine anxiety and depression symptoms
timeFrame: 15 weeks
measure: Follow-up: Benzodiazepine sleep distress
timeFrame: 15 weeks
Locations:
city: Trondheim
country: Norway
facility: Blue Cross, Clinic Lade
state: Trøndelag
Study officials:
affiliation: NTNU, Blue Cross, Clinic Lade, St. Olavs hospital
name: Tone Aurora Pleym, MD, PhD-candidate
role: STUDY_CHAIR
References: