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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Blfw Csmucr Cwkktu Lits	Trondheim	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not yet recruiting	01.03.2022

Trial locations

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.

Investigated diseases:

Drug use disorder

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 ID:

2024-516262-11-00

Protocol code:

LBS180319

Trial Phase:

Therapeutic exploratory (Phase II)

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