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AuthorisedTherapeutic exploratory (Phase II)Interventional

Leveraging the neural mechanisms of social reward for drug relapse prevention

This study is investigating if a special nose spray, called Syntocinon, can help people who are trying to recover from substance use disorder. The spray works by affecting certain brain processes linked to how we feel about social rewards. Researchers believe that by influencing these brain areas, Syntocinon might help reduce cravings for substances and prevent people from relapsing back into old habits. Participants will use either the Syntocinon spray or a non-active (placebo) nose spray. The study will look at how their cravings change over time, and use special brain scans (fMRI) to see how their brains respond. This research hopes to find new ways to support people in their journey to recovery.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Fondazione Santa Lucia IRCCS
Enrolment target
70
Start
29 May 2026

What is this study about?

This research study is looking into new ways to help people who are recovering from substance use disorder. This is a condition where someone uses substances in a way that harms them or others. The study is particularly interested in how our brains respond to social rewards — these are feelings of pleasure we get from interacting with other people or being part of a group. Some scientists believe that by helping the brain respond more positively to social interactions, it might reduce the strong urge, or 'craving', for substances.

The study will involve a special nose spray called Syntocinon. This spray is being investigated to see if it can help reduce cravings and prevent people from returning to substance use. Participants will receive either the active Syntocinon spray or a placebo spray, which looks and feels the same but doesn't contain the active ingredient. Comparing these two groups helps researchers understand if the Syntocinon spray is actually having an effect.

Researchers will use different methods to understand how the spray might be working. This includes asking participants about their cravings and using a special type of brain scan called fMRI. These scans help to see which parts of the brain are active when people are shown things that might trigger cravings. The study will also look at how long people are able to stay abstinent (not use substances). This is a Phase II study, which means it’s still in the early stages of exploring if the treatment works and is safe.

Key takeaways

  • The study explores a nose spray (Syntocinon) for substance use disorder.
  • It aims to see if the spray can reduce cravings and prevent relapse.
  • Brain scans (fMRI) and questionnaires will measure changes.
  • Participants will receive either the active spray or a placebo.
  • Follow-up will continue for several months after treatment.
  • The study could lead to new ways to help people in recovery.

Who may be eligible?

To join this study, participants need to be at least 18 years old – there's no upper age limit. The study is open to both men and women.

Beyond basic age and gender, further specific details about who can or cannot join will be discussed with the research team. This might include aspects of your medical history, current health, and the type of substance use disorder you have. These details are important to make sure the study is safe and suitable for you, and that the results will be accurate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you at least 18 years old?
  2. Are you able to attend regular appointments for the study?
  3. Are you willing to complete questionnaires about your cravings?
  4. Are you able to have a brain scan (fMRI)?
  5. Are you comfortable potentially receiving a placebo instead of active treatment?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the active Syntocinon nose spray or a placebo nose spray. You won't know which one you're getting, as this helps to make the study fair. You'll use this spray for a period of time, and throughout this time, researchers will check in with you.

Participation will involve several visits. You'll be asked to complete questionnaires about your cravings for substances, usually on specific days like day 1, day 7, and day 30. You'll also have brain scans (fMRI) at the beginning (day 1) and again after about a month (day 30) to see how your brain activity might change. On some visits, you'll do tasks on a computer or screen that look at how your brain responds to social situations and emotions.

After you finish using the spray, the research team will follow up with you at 3 and 6 months to see how you're doing and to check on your abstinence from substances. The whole process, from starting the spray to the final follow-up, will last for several months.

Potential risks and benefits

Participating in this study might offer a chance to receive a new treatment that could help reduce cravings and prevent relapse if the Syntocinon spray proves effective. This research could also provide valuable information to help others with substance use disorder in the future. As with any medication, there's always a chance of side effects from the Syntocinon spray, though these would be carefully monitored. The placebo spray is considered very safe as it doesn't contain any active medication. The fMRI scans are generally safe but involve lying still in a scanner. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Italy

Common questions

What is Syntocinon?

Syntocinon is a nose spray that researchers believe might help reduce cravings for substances by affecting how our brain processes social rewards.

What is a placebo nose spray?

A placebo nose spray looks and feels exactly like the active Syntocinon spray but does not contain any active medicine. It's used to fairly compare the effects of the active spray.

What does a brain scan (fMRI) involve?

An fMRI scan is a special kind of brain scan that shows which parts of your brain are active. You'll lie still in a scanner for a period of time.

How long will I be in the study?

The main treatment period is about a month, but researchers will follow up with you for several months after that to see how you're doing.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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