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Study of Intranasal Oxytocin Treatment for Patients with Benzodiazepine Withdrawal Symptoms: A Comparison with Placebo during Diazepam Dose Reduction

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating benzodiazepine dependence, a condition where a person has become dependent on medications commonly used for anxiety and sleep problems. The research examines whether using oxytocin nasal spray along with gradually reducing diazepam doses can help manage withdrawal symptoms when stopping benzodiazepines.

The study compares two approaches: one group receives oxytocin nasal spray while the other receives a placebo, both in addition to a gradual reduction of diazepam over 21 days. Both treatments are given through the nose as a spray. The purpose is to determine if oxytocin can help reduce the discomfort that people experience when stopping benzodiazepine medications.

During the study, participants receive either oxytocin nasal spray or placebo spray daily, while their regular benzodiazepine medication is slowly decreased. The treatment continues for three weeks, during which various aspects of withdrawal symptoms are monitored, including anxiety levels and sleep patterns.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and baseline measurement

    Your withdrawal symptoms will be measured using a special assessment tool called CIWA-B before starting the treatment

    This assessment includes 20 different items related to how you feel during withdrawal

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either oxytocin nasal spray or a placebo nasal spray

    The treatment will be added to your regular diazepam dose reduction plan

  3. Step 3

    Daily treatment period

    You will use the assigned nasal spray daily for 21 days

    Your withdrawal symptoms will be measured daily using the CIWA-B assessment

    The medical team will monitor your progress throughout the treatment period

  4. Step 4

    Additional assessments

    Your anxiety and depression levels will be evaluated using the Hamilton Anxiety and Depression Scale

    Your sleep quality will be assessed using the Insomnia Severity Index

    Special devices will monitor your rest and movement patterns during sleep

  5. Step 5

    Final evaluation

    On day 21, a final assessment of your withdrawal symptoms will be conducted

    The results will be compared to your initial measurements to evaluate the effectiveness of the treatment

Who can join the trial?

8 criteria

  • Must be between 18 and 65 years old
  • Currently taking benzodiazepines (medications commonly used for anxiety and sleep, such as diazepam) at a daily dose equivalent to 20-80 mg of diazepam
  • Requires inpatient withdrawal treatment (treatment that takes place in a hospital or medical facility where you stay overnight)
  • Must provide informed consent (written agreement to participate in the study after understanding all the details)
  • Can be either male or female
  • Must be willing to undergo a 21-day treatment program
  • Must be able to follow the study protocol, including daily assessments of withdrawal symptoms
  • Must be willing to receive either the study medication or placebo (inactive substance) through nasal spray

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Currently pregnant or breastfeeding women
  • History of allergic reactions to oxytocin or similar medications
  • Severe heart, kidney, or liver problems
  • Current diagnosis of severe psychiatric disorders (besides benzodiazepine dependence)
  • Use of other psychoactive substances or alcohol dependence
  • Inability to follow the 21-day treatment schedule
  • Nasal conditions that could interfere with intranasal medication delivery
  • Current participation in other clinical trials
  • Inability to provide informed consent
  • History of seizures or epilepsy
  • Severe respiratory problems
  • Taking medications that could interact with oxytocin
  • Unstable medical conditions that require frequent medication changes
  • History of adverse reactions to benzodiazepine withdrawal
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Investigated drugs

Oxytocin A hormone given as a nasal spray that may help reduce withdrawal symptoms when stopping benzodiazepines. It's being tested to see if it can make the withdrawal process easier and more comfortable for patients. Diazepam A benzodiazepine medication that will be gradually reduced in dose over time. This medication is commonly used for anxiety and sleep problems, and the study looks at ways to help patients safely stop taking it with fewer withdrawal effects. Note: The trial also includes a placebo (inactive substance) administered nasally, but as requested, this has been excluded from the description.

What is already known about the treatment

  • Oxytocin

    A naturally occurring hormone that is being studied as an intranasal medication for treating benzodiazepine withdrawal symptoms. This peptide hormone, administered through nasal spray, is being investigated for its potential to reduce withdrawal symptoms during benzodiazepine tapering, particularly when combined with diazepam dose reduction. Oxytocin works by binding to specific receptors in the brain, potentially helping to regulate anxiety, stress responses, and social behavior, which may be beneficial during drug withdrawal. The medication belongs to the class of neurohypophysial hormones and is currently being evaluated in clinical trials for its effectiveness in addiction treatment.

  • Diazepam

    A long-acting benzodiazepine medication that is administered orally and commonly used in supervised withdrawal protocols. It acts by enhancing the effects of GABA, the main inhibitory neurotransmitter in the brain, producing calming and anxiety-reducing effects. Diazepam belongs to the benzodiazepine class of medications and is used in carefully controlled dose reduction regimens to help patients safely withdraw from benzodiazepine dependence, while minimizing withdrawal symptoms and potential complications.

Investigated diseases

Benzodiazepine Dependence - A condition that develops when a person becomes physically and psychologically dependent on benzodiazepine medications. It typically occurs after regular use of these medications, even when taken as prescribed. The condition is characterized by tolerance, where increasing amounts of the drug are needed to achieve the same effect. When use is reduced or stopped, withdrawal symptoms can develop, including anxiety, sleep problems, and physical discomfort. The body becomes adapted to the presence of benzodiazepines, making it difficult to function normally without them. People with this condition often experience strong cravings and difficulty controlling their medication use.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516262-11-00Protocol codeLBS180319Estimated enrolment60 patientsSponsorSt. Olavs Hospital HF

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