Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000988358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
7/07/2026
Date registered
Help: Date registered
12/08/2026
Date last updated
Help: Date last updated
12/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
12/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Impairing the Reconsolidation of Emotional Memories with Propranolol: An Investigation of the Role of Oestrogen in Women with Probable Trauma and Stressor-Related Disorders (TSRD)
Scientific title
Impairing the Reconsolidation of Emotional Memories with Propranolol: An Investigation of the Role of Oestrogen in Women with Probable Trauma and Stressor-Related Disorders (TSRD)
Additional trial identifiers [1] 317498 0
None
Universal Trial Number (UTN)
Trial acronym
REPAIR-W
Related trial records

Health condition
Health condition(s) studied:
Post traumatic stress disorder 342225 0
Trauma and Stressor-Related Disorders (TSRD) 342927 0
Condition category
Condition code
Mental Health 338347 338347 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Interventional

A single session of memory reconsolidation blockade, involving facilitated, script-driven trauma recall following ingestion of oral propranolol. The intervention will be timed according to the participant’s menstrual cycle phase, specifically the early follicular ("low" oestrogen) or late follicular ("high" oestrogen) phase (intervention). Scheduling will be based on convenience (not randomised), with the intervention conducted during the menstrual cycle phase that is closest to the participant’s current cycle timing and availability. This session will take approximately 30 minutes and will be delivered by trained mental health clinician. The participant and practitioner will work together to identify the core trauma memory for the intervention and will be invited to complete a script driven recall of the event. Once completed, and provided no adverse effects were observed or reported, the participant can leave the premises.

Drug trial
Low-dose oral tablet propranolol (APO-Propranolol® manufactured by Apotex Pty Ltd) treatment (1mg/kg for ideal weight; ideal body weight is calculated from the participant’s height). Medication is administered on-site, approximately 60 minutes before the trauma recall session. Participant's tolerability of the medication will be assessed prior to the intervention session during baseline assessment, under observation of a registered nurse. During this medication tolerability session, the PTSD research clinic doctor/nurse practitioner will be on-site to respond to potential hypotensive events and ensure participant safety.

Intervention code [1] 334627 0
Treatment: Drugs
Intervention code [2] 334628 0
Behaviour
Description of the comparator or control
There is no placebo or control group. Participants receiving the intervention during the early follicular phase ("low" oestradiol) will be compared with those receiving the same intervention during the late follicular phase ("high" oestradiol). Early follicular phase is the comparator. Blood/saliva samples will be collected to quantify oestradiol concentrations, enabling analyses of treatment response according to both menstrual cycle phase and/or continuous oestradiol concentrations.

Drug trial
Low-dose oral tablet propranolol (APO-Propranolol® manufactured by Apotex Pty Ltd) treatment (1mg/kg for ideal weight; ideal body weight is calculated from the participant’s height). Medication is administered on-site, approximately 60 minutes before the single trauma recall session. Participant's tolerability of the medication will be assessed prior to the intervention session during baseline assessment, under observation of a registered nurse. During this medication tolerability session, the PTSD research clinic doctor/nurse practitioner will be on-site to respond to potential hypotensive events and ensure participant safety.
Control group
Active

Outcomes
Primary outcome [1] 346037 0
The primary outcome is change in self-reported trauma- and stressor-related symptoms, assessed as a composite total score.
Timepoint [1] 346037 0
Primary symptom data will be acquired via self-report on the intervention day (T1), and one week post treatment (T2)
Primary outcome [2] 346287 0
The primary outcome is change in self-reported PTSD symptoms,assessed as a composite total score.
Timepoint [2] 346287 0
Primary symptom data will be acquired via self-report on the intervention day (T1), and one week post treatment (T2).
Secondary outcome [1] 464407 0
The secondary outcome is the comparison of self-reported trauma- and stressor-related symptom change (IES-R composite total scores) between participants treated during low oestradiol (early follicular) and high oestradiol (late follicular) menstrual cycle phases, with oestradiol levels examined as a continuous variable and/or dichotomised as "high" versus "low".
Timepoint [1] 464407 0
A blood and saliva sample will be collected on treatment day (T1) to determine oestrogen concentrations.. Retrospective mapping of menstrual cycle characteristics will be conducted during the baseline assessment via an interview, prior to the treatment day. Participants will be provided with the home ovulation kit during the baseline assessment.

Eligibility
Key inclusion criteria
• Participant must be a biological female (i.e., assigned female at birth)
• Participants must be English-speaking
• Participant must be aged between 18 and 40 (inclusive)
• Participant must be naturally cycling (i.e., not on hormonal contraceptives)
• Participant must menstruate (i.e., non-menopausal)
• Participant must be comfortable having a blood test
• Participants must be able to understand and provide written informed consent on the Participant Informed Consent Form (PICF)
• Participant must meet criteria for a probable Trauma and Stressor-Related (TSR) disorder according to the validated IES-R scale (cut-off score of 33) and the clinical global impression (CGI) scale.
• Participant must be able to attend the Thompson Institute's National PTSD Research Centre (TI/NPRC) in-person for all baseline testing (~4hrs) and the Reconsolidation Therapy (RT) day (~ 115 mins).
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Healthy volunteers
No
Key exclusion criteria
• Contraception use within the 3 months prior, including hormonal contraceptives, intrauterine device, intrauterine system, or tubal ligation.
• Self-reported or observed significant psychiatric condition such as, but not limited to psychosis, bipolar disorder, borderline personality disorder, severe substance use disorder, anorexia nervosa
• Meeting known contraindications for propranolol (e.g., basal systolic blood pressure <100mmHg, basal pulse rate <60 BPM, asthma), or not tolerating the medication
• Previous allergy or reaction to propranolol, or other beta-adrenergic blocking agent
• Participation in conflicting research studies at the time of enrolment
• Currently receiving any form of psychotherapy for trauma related symptoms
• Currently pregnant, breastfeeding or intending to become pregnant during the study
• Any other condition that, in the opinion of the investigator, may adversely impact the safety of the participant or the accuracy of the study data

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/08/2026
Actual
Date of last participant enrolment
Anticipated
2/11/2026
Actual
Date of last data collection
Anticipated
14/12/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 322067 0
University
Name [1] 322067 0
University of the Sunshine Coast
Country [1] 322067 0
Australia
Primary sponsor type
Individual
Name
Prof Ross Young - University of the Sunshine Coaast
Address
Country
Australia
Secondary sponsor category [1] 324947 0
Individual
Name [1] 324947 0
Prof Alain Brunet - University of the Sunshine Coast
Address [1] 324947 0
Country [1] 324947 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320595 0
Human Research Ethics Committee of the University of the Sunshine Coast
Ethics committee address [1] 320595 0
Ethics committee country [1] 320595 0
Australia
Date submitted for ethics approval [1] 320595 0
12/02/2026
Approval date [1] 320595 0
26/05/2026
Ethics approval number [1] 320595 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151002 0
Dr Ciara Treacy
Address 151002 0
12 Innovation Parkway, Birtinya, 4575, QLD (UniSC Thompson Institute)
Country 151002 0
Australia
Phone 151002 0
+61 754563877
Fax 151002 0
Email 151002 0
[email protected]
Contact person for public queries
Name 151003 0
Ciara Treacy
Address 151003 0
12 Innovation Parkway, Birtinya, 4575, QLD (UniSC Thompson Institute)
Country 151003 0
Australia
Phone 151003 0
+61 754563877
Fax 151003 0
Email 151003 0
[email protected]
Contact person for scientific queries
Name 151004 0
Ciara Treacy
Address 151004 0
12 Innovation Parkway, Birtinya, 4575, QLD (UniSC Thompson Institute)
Country 151004 0
Australia
Phone 151004 0
+61 754563877
Fax 151004 0
Email 151004 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.