Post-traumatic Stress DisorderPhase 2REDUCTRAUMA2NCT01713556
Treatment of PTSD by Reduction of Traumatic Memory Reconsolidation by Propranolol : a Multisite Trial
A Phase 2 study testing Propranolol and Trauma reactivation in people with Post-traumatic Stress Disorder, run by University Hospital, Toulouse at 4 sites in France.
Trial summary
The purpose of this study is to test whether propranolol, when given during a re-evocation of a traumatic memory, is capable of reducing subsequent PTSD symptoms associated with that memory. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Propranolol and Trauma reactivation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2012to 30 Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic PTSD
- PTSD CheckList total score >44
Who cannot join
- Systolic blood pressure < 100 mmHg
- Contraindication to Propranolol
- Previous adverse reaction to a β-blocker
- Use of another β-blocker
- Use of medication that could involve potentially dangerous interactions with propranolol
- Psychotherapy or treatment with any pharmacologic PTSD medication within the 2 weeks prior to inclusion (6 weeks for fluoxetine)
Show all 9Show fewer
- Female with reproductive potential without reliable means of contraception
- Pregnancy or lactation
- Alcohol or drug abuse
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalier Charles Perrens
Bordeaux, 33076
Chru Lille
Lille, 59037
Chu Montpellier
Montpellier, 34295
CHU Toulouse
Toulouse, 31000
About this study
The purpose of this study is to test whether propranolol, when given during a re-evocation of a traumatic memory, is capable of reducing subsequent PTSD symptoms associated with that memory.
Read the detailed description
Post-traumatic stress disorder (PTSD) develops following an exposure to a life threatening event. One of the characteristic features of PTSD is the recurrence of intrusive memories of an experienced trauma. The persistence of disturbing traumatic memories in PTSD is often explained in terms of a trauma-induced enhancement of memory encoding. Several studies indicate that an increased noradrenergic activity during trauma enhances the encoding of memory. Elevated levels of norepinephrine in the cerebrospinal fluid of individuals with PTSD and the correlation of this elevation with the severity of PTSD symptoms suggest that increased noradrenergic activity is also involved in the maintenance of PTSD symptoms. Reactivation of memory by retrieval also renders the memory labile and susceptible to treatments. This latter process is referred to as memory reconsolidation. Consolidation and reconsolidation both occur within a distinct time window following new learning (in consolidation) and/or retrieval (in reconsolidation). Even well-consolidated old fear memories undergo reconsolidation and may be disrupted by means of pharmacological manipulation. Propranolol may be effective in treating PTSD long after symptoms have been consolidated. Propranolol given after reactivation of the memory of a past traumatic event reduces physiologic responding during subsequent mental imagery of the event.
HYPOTHESE: Subjects with chronic PTSD who receive propranolol before trauma evocation will subsequently show decreased PTSD symptoms, compared to subjects who receive a placebo.
METHOD: 56 participants with chronic PTSD will be recruited for participation. On Week 1, the subjects will complete a standardized measure of PTSD symptoms. Next, 90 minutes after the administration of the study medication (either propranolol or placebo), participants will undergo a script preparation procedure, during which they will disclose details of their traumatic event. Scripts portraying this event will be prepared for subsequent replay.
On Week 2, after the administration of the study medication (either propranolol or placebo), participants will be asked (reading the script) to engaged in a script-driven mental imagery of the traumatic event. Following this procedure, PTSD symptoms will be assessed.
The same procedure will be repeated on Weeks 3, 4, 5 and 6. On Weeks 7 and 18, the standardized measure of PTSD symptoms will be repeated.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Propranolol, Trauma reactivation, placebo
- Keywords
- PTSD, Propranolol
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Trauma reactivationOther
Trauma reactivation: script-driven mental imagery of the traumatic event
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Propranolol + reactivation | Experimental | they have a script-driven mental imagery of the traumatic event white drug Receives: Drug: Propranolol; Other: Trauma reactivation |
| Placebo + reactivation | Placebo comparator | They have a script-driven mental imagery of the traumatic event with placebo Receives: Other: Trauma reactivation; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTCD CheckList (PCL) total score.
Measured: difference between week 1 (before administration of the study medication) and week 7 (one week after the last intake of study medication)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe BIRMES, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713556
- Sponsor's protocol ID
- 09 106 01
- Acronym
- REDUCTRAUMA2
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2012
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Very E, Leroy A, Richaud L, Vaiva G, Jardri R, Roullet P, Taib S, Bourcier A, Loubinoux I, Birmes P. Hippocampal connectivity changes after traumatic memory reactivation with propranolol for posttraumatic stress disorder: a randomized fMRI study. Eur J Psychotraumatol. 2025 Dec;16(1):2466886. doi: 10.1080/20008066.2025.2466886. Epub 2025 Apr 22.
PubMed 40261001Roullet P, Taib S, Thalamas C, Vaiva G, El Hage W, Yrondi A, Birmes P. Efficacy of traumatic memory reactivation with or without propranolol in PTSD with high dissociative experiences. Eur J Psychotraumatol. 2022 Dec;13(2):2151098. doi: 10.1080/20008066.2022.2151098. Epub 2022 Dec 1.
PubMed 38872596Roullet P, Vaiva G, Very E, Bourcier A, Yrondi A, Dupuch L, Lamy P, Thalamas C, Jasse L, El Hage W, Birmes P. Traumatic memory reactivation with or without propranolol for PTSD and comorbid MD symptoms: a randomised clinical trial. Neuropsychopharmacology. 2021 Aug;46(9):1643-1649. doi: 10.1038/s41386-021-00984-w. Epub 2021 Feb 21.
PubMed 33612830Leroy A, Very E, Birmes P, Yger P, Szaffarczyk S, Lopes R, Outteryck O, Faure C, Duhem S, Grandgenevre P, Warembourg F, Vaiva G, Jardri R. Intrusive experiences in posttraumatic stress disorder: Treatment response induces changes in the directed functional connectivity of the anterior insula. Neuroimage Clin. 2022;34:102964. doi: 10.1016/j.nicl.2022.102964. Epub 2022 Feb 10.
PubMed 35189456Raymond V, Hassan J, Roullet P, Leveque A, Geoffroy PA, Yrondi A, Birmes P. Preferential Improvement of Trauma-Related Distressing Dreams Following Traumatic Memory Reactivation in Severe PTSD: A Secondary Analysis of a Randomized Placebo-Controlled Trial. J Sleep Res. 2026 Nov 4:e70491. doi: 10.1111/jsr.70491. Online ahead of print.
PubMed 42984251
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of PTSD by Reduction of Traumatic Memory Reconsolidation by Propranolol : a Multisite Trial
- ClinicalTrials.gov ID
- NCT01713556
- Acronym / sponsor ID
- REDUCTRAUMA2 / 09 106 01
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- PTSD, Propranolol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 24 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether propranolol, when given during a re-evocation of a traumatic memory, is capable of reducing subsequent PTSD symptoms associated with that memory.
Detailed description
Post-traumatic stress disorder (PTSD) develops following an exposure to a life threatening event. One of the characteristic features of PTSD is the recurrence of intrusive memories of an experienced trauma. The persistence of disturbing traumatic memories in PTSD is often explained in terms of a trauma-induced enhancement of memory encoding. Several studies indicate that an increased noradrenergic activity during trauma enhances the encoding of memory. Elevated levels of norepinephrine in the cerebrospinal fluid of individuals with PTSD and the correlation of this elevation with the severity of PTSD symptoms suggest that increased noradrenergic activity is also involved in the maintenance of PTSD symptoms. Reactivation of memory by retrieval also renders the memory labile and susceptible to treatments. This latter process is referred to as memory reconsolidation. Consolidation and reconsolidation both occur within a distinct time window following new learning (in consolidation) and/or retrieval (in reconsolidation). Even well-consolidated old fear memories undergo reconsolidation and may be disrupted by means of pharmacological manipulation. Propranolol may be effective in treating PTSD long after symptoms have been consolidated. Propranolol given after reactivation of the memory of a past traumatic event reduces physiologic responding during subsequent mental imagery of the event.
HYPOTHESE: Subjects with chronic PTSD who receive propranolol before trauma evocation will subsequently show decreased PTSD symptoms, compared to subjects who receive a placebo.
METHOD: 56 participants with chronic PTSD will be recruited for participation. On Week 1, the subjects will complete a standardized measure of PTSD symptoms. Next, 90 minutes after the administration of the study medication (either propranolol or placebo), participants will undergo a script preparation procedure, during which they will disclose details of their traumatic event. Scripts portraying this event will be prepared for subsequent replay.
On Week 2, after the administration of the study medication (either propranolol or placebo), participants will be asked (reading the script) to engaged in a script-driven mental imagery of the traumatic event. Following this procedure, PTSD symptoms will be assessed.
The same procedure will be repeated on Weeks 3, 4, 5 and 6. On Weeks 7 and 18, the standardized measure of PTSD symptoms will be repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol + reactivation | Experimental | Drug: Propranolol, Other: Trauma reactivationthey have a script-driven mental imagery of the traumatic event white drug |
| Placebo + reactivation | Placebo comparator | Other: Trauma reactivation, Drug: placeboThey have a script-driven mental imagery of the traumatic event with placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of chronic PTSD
- PTSD CheckList total score >44
Key exclusion criteria (9 listed)
- Systolic blood pressure < 100 mmHg
- Contraindication to Propranolol
- Previous adverse reaction to a β-blocker
- Use of another β-blocker
- Use of medication that could involve potentially dangerous interactions with propranolol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol | Drug | Propranolol + reactivation |
| Trauma reactivationTrauma reactivation: script-driven mental imagery of the traumatic event | Other | Placebo + reactivation, Propranolol + reactivation |
| placebo | Drug | Placebo + reactivation |
Primary outcome
PTCD CheckList (PCL) total score.
Time frame: difference between week 1 (before administration of the study medication) and week 7 (one week after the last intake of study medication)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Results publication: PubMed 40261001Very E, Leroy A, Richaud L, Vaiva G, Jardri R, Roullet P, Taib S, Bourcier A, Loubinoux I, Birmes P. Hippocampal connectivity changes after traumatic memory reactivation with propranolol for posttraumatic stress disorder: a randomized fMRI study. Eur J Psychotraumatol. 2025 Dec;16(1):2466886. doi: 10.1080/20008066.2025.2466886. Epub 2025 Apr 22.
- Results publication: PubMed 38872596Roullet P, Taib S, Thalamas C, Vaiva G, El Hage W, Yrondi A, Birmes P. Efficacy of traumatic memory reactivation with or without propranolol in PTSD with high dissociative experiences. Eur J Psychotraumatol. 2022 Dec;13(2):2151098. doi: 10.1080/20008066.2022.2151098. Epub 2022 Dec 1.
- Results publication: PubMed 33612830Roullet P, Vaiva G, Very E, Bourcier A, Yrondi A, Dupuch L, Lamy P, Thalamas C, Jasse L, El Hage W, Birmes P. Traumatic memory reactivation with or without propranolol for PTSD and comorbid MD symptoms: a randomised clinical trial. Neuropsychopharmacology. 2021 Aug;46(9):1643-1649. doi: 10.1038/s41386-021-00984-w. Epub 2021 Feb 21.
- Results publication: PubMed 35189456Leroy A, Very E, Birmes P, Yger P, Szaffarczyk S, Lopes R, Outteryck O, Faure C, Duhem S, Grandgenevre P, Warembourg F, Vaiva G, Jardri R. Intrusive experiences in posttraumatic stress disorder: Treatment response induces changes in the directed functional connectivity of the anterior insula. Neuroimage Clin. 2022;34:102964. doi: 10.1016/j.nicl.2022.102964. Epub 2022 Feb 10.
- Derived from this study: PubMed 42984251Raymond V, Hassan J, Roullet P, Leveque A, Geoffroy PA, Yrondi A, Birmes P. Preferential Improvement of Trauma-Related Distressing Dreams Following Traumatic Memory Reactivation in Severe PTSD: A Secondary Analysis of a Randomized Placebo-Controlled Trial. J Sleep Res. 2026 Nov 4:e70491. doi: 10.1111/jsr.70491. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe BIRMES, MD principal investigator
University Hospital, Toulouse
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol and Trauma reactivation in people with Post-traumatic Stress Disorder, run by University Hospital, Toulouse at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTCD CheckList (PCL) total score. (time frame: difference between week 1 (before administration of the study medication) and week 7 (one week after the last intake of study medication)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01713556, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.