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Study on Oxytocin and Sodium Chloride for Preventing Drug Relapse in Individuals with Substance Use Disorder

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What is this trial about?

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

This clinical trial is focused on studying substance use disorder, a condition where individuals have an uncontrollable urge to use drugs such as heroin or cocaine. The study is testing a treatment called Syntocinon, which is a nasal spray containing the active substance oxytocin. Oxytocin is a hormone that is naturally produced in the body and is known for its role in social bonding and reducing stress. The trial will also use a nasal spray with sodium chloride, which is a simple salt solution, as a comparison.

The purpose of the study is to see if Syntocinon can help reduce cravings for drugs and prevent relapse in individuals with substance use disorder. Participants in the study will use the nasal spray for a period of four weeks. During this time, they will be monitored to see how their cravings change and whether they are able to stay away from drug use. The study will also look at how the brain responds to the treatment using a special type of brain scan called fMRI, which helps to see which areas of the brain are active.

Throughout the study, participants will be asked to complete tasks that measure their social and emotional responses. These tasks are designed to see if the treatment has any effect on how they interact with others and manage their emotions. The study will also follow up with participants at three and six months after the treatment to see how long they can maintain abstinence from drug use. The goal is to find out if Syntocinon can be an effective tool in helping people with substance use disorder to reduce cravings and avoid relapse.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study's purpose and procedures.

    You will need to confirm your primary diagnosis of substance use disorder and meet other criteria such as age and language requirements.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your current condition. This may include questionnaires and interviews to understand your history with substance use.

  3. Step 3

    Treatment period

    During the treatment period, you will receive a nasal spray called Syntocinon, which contains oxytocin and sodium chloride. This is administered through the nose.

    The treatment will last for four weeks. You will use the nasal spray as directed by the study team.

  4. Step 4

    Evaluation of cravings

    Your cravings for substances will be evaluated at different points: on day 7 and day 30 of the treatment period. This involves self-reporting your cravings after being exposed to certain cues.

    On day 30, a brain scan may be conducted to observe changes in brain activity.

  5. Step 5

    Social and emotional tasks

    You will participate in tasks designed to measure social and emotional responses. These tasks include viewing pictures, responding to cues, and engaging in interactive activities.

    These tasks will be conducted on day 7 and day 30 to assess any changes in your responses.

  6. Step 6

    Follow-up assessments

    After the treatment period ends, follow-up assessments will be conducted at 3 and 6 months. These assessments will evaluate your duration of abstinence from substance use.

    You will be asked about your substance use during these follow-ups to monitor any changes.

Who can join the trial?

6 criteria

  • Have a primary diagnosis of substance use disorder according to DSMV criteria. This means a doctor has determined that you have a pattern of using substances like drugs that leads to significant problems or distress.
  • Be a male or a non-pregnant, non-lactating female. This means you can be a man or a woman who is not currently pregnant or breastfeeding.
  • Be aged between 18 and 55 years old.
  • Be willing and able to give informed consent. This means you understand the study and agree to participate.
  • Have an understanding of the Italian language.
  • Provide an identity document, such as a passport or ID card.

Who cannot join the trial?

3 criteria

  • Individuals who are not within the age range specified for the study.
  • Individuals who are not diagnosed with a substance use disorder (a condition where a person is dependent on drugs like heroin or cocaine).
  • Individuals who are part of a vulnerable population (groups that may need special protection, such as children or people with certain disabilities).
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Investigated drugs

Syntocinon is a medication used in this clinical trial to help people who are dependent on drugs like heroin or cocaine. The main goal of using Syntocinon is to reduce the strong desire or craving for these drugs. By doing so, it aims to help prevent individuals from returning to drug use after they have stopped. Syntocinon works by influencing certain brain mechanisms related to social reward, which may play a role in reducing cravings and supporting recovery from drug addiction.

What is already known about the treatment

Syntocinon – Syntocinon is administered as a nasal spray, making it easy to use. It is currently being studied in clinical trials to assess its effectiveness in reducing cravings for drugs like heroin and cocaine, and in preventing relapse in individuals with substance use disorders. The medication works by influencing the brain's reward system, potentially altering the neural mechanisms associated with social reward, which may help reduce the desire for drug use. Syntocinon is classified pharmacologically as a synthetic form of oxytocin, a hormone that plays a role in social bonding and behavior.

Investigated diseases

Substance Use Disorder – Substance use disorder is a condition characterized by an individual's inability to control the use of a legal or illegal drug or medication. The disorder involves a pattern of behaviors where the person continues to use the substance despite harmful consequences. Over time, the individual may develop a tolerance, requiring more of the substance to achieve the same effect. The progression of the disorder often includes withdrawal symptoms when the substance is not used. It can lead to significant impairment in daily life, affecting personal and professional responsibilities. The disorder can involve a variety of substances, including alcohol, prescription medications, and illicit drugs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504518-31-00Estimated enrolment70 patientsSponsorFondazione Santa Lucia

sourced from the EU Clinical Trials Register and site verification

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