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

NCT06757517 | Recruiting Phase 2 DMC

• 1 other identifier: 32672
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Benzodiazepine Dependence

Keywords

intranasal oxytocin; oxytocin; benzodiazepines; benzodiazepine dependence; benzodiazepine withdrawal

Outcome Measures

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.

  21 days

Secondary Outcomes (4)

• Benzodiazepine craving

  21 days

• Benzodiazepine anxiety and depression symptoms

  21 days

• Benzodiazepine sleep distress

  21 days

• Benzodiazepine tapering "freezes"

  21 days

Other Outcomes (5)

• Follow-up: Relapse

  15 weeks

• Follow-up: Benzodiazepine withdrawal symptoms

  15 weeks

• Follow-up: Benzodiazepine craving

  15 weeks

Study Arms (2)

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.

Drug: Saline (NaCl 0,9 %) (placebo)

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.

Drug: Oxytocin nasal spray

Interventions

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).

Also known as: Syntocinon

Oxytocin

Saline (NaCl 0,9 %) (placebo) DRUG

Saline intranasal placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator
• Lade Behandlingssenter, Blå Kors: collaborator

Study Sites (1)

Blue Cross, Clinic Lade

Trondheim, Trøndelag, 7091, Norway

RECRUITING

MeSH Terms

Interventions

Oxytocin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Tone Aurora Pleym, MD, PhD-candidate

  NTNU, Blue Cross, Clinic Lade, St. Olavs hospital

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: January 3, 2025
• Study Start: March 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 3, 2025

Record last verified: 2025-01

Locations

NO (1)