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AuthorisedTherapeutic confirmatory (Phase III)Interventional

Women victims of violences : PTSD treatment by traumatic memory reactivation under the influence of propranolol (VIOFEM)

Post-traumatic stress disorder (PTSD) can cause distressing flashbacks, severe anxiety, and low mood after going through traumatic events such as violence. This clinical trial, called VIOFEM, is investigating whether combining a medication called propranolol with memory recall therapy can help women recover. Propranolol is a widely used tablet often prescribed for high blood pressure and physical symptoms of anxiety. In this study, participants take the tablet before briefly recalling their painful memory with a trained professional. The goal is to weaken the intense emotional response linked to that memory over time. Researchers will compare this approach with a standard talking therapy for trauma called Prolonged Exposure. They will track changes in PTSD symptoms, depression, and general wellbeing over six months to see which treatment offers better and longer-lasting relief.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Centre Hospitalier Universitaire De Toulouse
Enrolment target
76
Start
24 Jun 2026

What is this study about?

Experiencing violence can have a profound impact on emotional and mental health. Many women develop post-traumatic stress disorder (PTSD), where distressing memories remain vividly 'stuck' in the mind. These memories can trigger severe panic, nightmares, and feelings of constant danger long after the trauma has passed. Finding treatments that bring gentle, reliable relief is crucial for long-term healing.

The VIOFEM study tests an approach known as memory reactivation under propranolol. Propranolol is a beta-blocker medication that temporarily calms the body's physical 'fight or flight' stress response. Scientists believe that when a traumatic memory is remembered while the physical stress response is blocked, the brain can store that memory again in a much calmer, less painful way. The memory itself is not erased, but its distressing emotional charge is reduced.

In this Phase III study, researchers are comparing this medication-assisted therapy to Prolonged Exposure, which is one of the most common standard talking therapies for PTSD. Women taking part will complete several treatment sessions and regular check-ins to see how their symptoms change over time.

By following participants for up to six months, the study hopes to discover whether this combined treatment is quicker or more effective than traditional therapy alone. If successful, it could provide doctors with a valuable new tool to help survivors of trauma rebuild their lives.

Key takeaways

  • The study tests whether taking propranolol before recalling a trauma memory helps treat PTSD in women.
  • The new method is being compared directly against standard talking therapy for trauma.
  • Propranolol aims to calm the physical stress response, not wipe away memories.
  • Participants will attend therapy sessions and have progress check-ins over six months.
  • Joining is completely voluntary, and you can withdraw at any time.

Who may be eligible?

This study is designed specifically for adult women aged 18 and older who are living with PTSD following experiences of violence. Participants need to have a formal diagnosis of PTSD or symptoms that match clinical criteria.

Because this trial involves the medication propranolol, participants must be medically safe to take a beta-blocker. People with certain heart conditions, very low blood pressure, or severe asthma may not be able to join, as propranolol can affect heart rate and breathing.

If you are already receiving other forms of psychological support or psychiatric medication, the study team will review these to ensure they do not interfere with the trial. A doctor or clinical researcher will go through a full health check with you before you agree to take part.

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. I am a woman aged 18 or older.
  2. I have experienced violence and am struggling with PTSD symptoms.
  3. I do not have severe asthma or heart conditions that prevent me from taking beta-blockers.
  4. I am able to attend weekly therapy sessions at the study centre.
  5. I am willing to complete follow-up questionnaires for up to six months.
Answer every question to see your result.

What does participation involve?

Taking part involves attending between six and eight guided therapy sessions over several weeks at a clinical centre. If you are allocated to the propranolol group, you will take a single tablet about an hour before a brief session where you re-read or discuss your trauma memory with a clinician. If you are in the comparison group, you will take part in structured Prolonged Exposure therapy sessions without the medication. Throughout the study, you will complete clinical interviews and questionnaires to assess your PTSD, mood, and emotional wellbeing. Follow-up appointments will take place one week, three months, and six months after your final session to see how well the benefits last. In total, your participation will last around six to seven months.

Potential risks and benefits

You may experience a meaningful reduction in your PTSD symptoms, emotional distress, and low mood, while helping researchers find better treatments for other women. However, no clinical trial can guarantee personal improvement. Talking about past trauma can feel upsetting or emotionally tiring, especially in the early stages. Propranolol is generally well tolerated, but common side effects can include temporary tiredness, dizziness, cold fingers, or a slower heart rate. You will be closely supported by trained mental health professionals throughout, and you have the absolute right to leave the study at any time without your regular medical care being affected.

Locations (1)

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

Common questions

Will propranolol erase my memories?

No. The medication does not erase your memories. Instead, it aims to reduce the intense physical fear and emotional panic attached to the memory when you recall it.

What is propranolol normally used for?

Propranolol is a commonly prescribed beta-blocker. It is routinely used in the NHS to treat high blood pressure, migraines, and the physical symptoms of anxiety, such as a racing heart.

Is taking part free?

Yes. Clinical trials do not charge participants for study medicines, therapy sessions, or research assessments.

What happens if I find the sessions too upsetting?

Trauma therapy can bring up difficult feelings. The clinical team includes trained mental health specialists who will support you. You can take a break or stop your participation at any time.

Can I choose which treatment group I join?

No. Participants are placed into treatment groups randomly by a computer. This ensures the study remains fair and scientific.

How to find out more

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

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