Using intranasal oxytocin to ease benzodiazepine withdrawal symptoms
Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot Randomized Parallell Group Placebo-Controlled Trial
This study is testing if a nasal spray of oxytocin can help adults feel better during benzodiazepine withdrawal by reducing anxiety, improving sleep, and lowering cravings.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Locations | 1 site (Trondheim, Trøndelag) |
| Trial ID | NCT06757517 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intranasal oxytocin in reducing withdrawal symptoms in adults undergoing benzodiazepine tapering over a 21-day period. Participants will be randomly assigned to receive either oxytocin or a placebo nasal spray, administered three times daily. The study will assess the impact of oxytocin on anxiety, sleep quality, and benzodiazepine cravings, using standardized scales for measurement. Daily questionnaires will be completed by participants to track their symptoms throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who are currently taking benzodiazepines and require inpatient withdrawal management.
Not a fit: Patients who are pregnant, breastfeeding, or have acute medical or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate withdrawal symptoms for patients tapering off benzodiazepines, improving their overall experience and outcomes.
How similar studies have performed: While the use of intranasal oxytocin for benzodiazepine withdrawal is a novel approach, preliminary studies suggest potential benefits in anxiety reduction.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Trondheim, Trøndelag
- Blue Cross, Clinic Lade — Trondheim, Trøndelag, Norway (Recruiting)
Study contacts
- Study coordinator: Tone Aurora Pleym, MD, PhD-candidate
- Email: tone.pleym@ntnu.no
- Phone: +47 97 62 55 83
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.