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Propranolol + Memory Reactivation for PTSD
Phase 4
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow up (week 11)
Awards & highlights
Study Summary
This trial will test if a memory-weakening intervention using propranolol can reduce PTSD symptoms when combined with a new technique to reactivate traumatic memories.
Who is the study for?
This trial is for men and women aged 18-65 who have experienced a traumatic event and show significant stress symptoms, with a PCL-5 score over 33. They must react strongly during baseline imagery testing to qualify. Exclusions include certain medical conditions like heart failure or asthma, low blood pressure or heart rate, drug abuse, pregnancy, other psychiatric disorders, current psychotherapy (except supportive), inability to understand English or give informed consent.Check my eligibility
What is being tested?
The study tests if adding an unexpected element ('mismatch') when recalling traumatic memories with propranolol can better reduce physiological stress responses than standard memory reactivation alone. Participants will be randomly assigned to either the mismatch/propranolol group or the standard/propranolol group and undergo six weekly sessions of memory reactivation.See study design
What are the potential side effects?
Propranolol may cause side effects such as dizziness due to lowered blood pressure, fatigue, difficulty breathing in those with respiratory issues, cold hands and feet from reduced circulation; it might also affect mood or sleep patterns.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ follow up (week 11)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow up (week 11)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite score of psychophysiological reactivity (comprising heart rate, skin conductance, and electromyography of the left corrugator muscle) using the Biopac system.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mismatch reactivation conditionExperimental Treatment2 Interventions
The participant will recite their trauma narrative to the psychologist for 10-20 minutes. However, during each recitation, a "mismatch" condition, different for each session, will be added to the reactivation procedure by having the participant do the following (in order of sessions.
Group II: Standard reactivation conditionActive Control2 Interventions
The intervention will be the same for each of the six intervention sessions. The participant will recite to the psychologist the narrative they previously composed for 10-20 min. The psychologist will congratulate the participant for having succeeded in this task and advise them they are finished for the day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Propranolol
2010
Completed Phase 4
~1290
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,561 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't started or changed any mental health medication in the last two months.I do not use drugs like opiates, marijuana, cocaine, amphetamines, or alcohol.I do not understand English, which is required for this trial.I am between 18-65, experienced a traumatic event, and have a high stress score.I understand the study's procedures, risks, and can give informed consent.I do not have heart issues, severe diabetes, or lung problems that would prevent me from undergoing PPNL.I am not taking medication that could dangerously interact with the study drug.We are looking for participants who have experienced a traumatic event, which may include those with PTSD.You have had a bad reaction to or have not followed instructions for taking a medication called a β-blocker in the past.During a specific test, participants need to meet certain mental and physical criteria to be randomly selected for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Mismatch reactivation condition
- Group 2: Standard reactivation condition
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor recruiting individuals aged 45 or older?
"Eligibility criteria for this trial requires applicants to be younger than 65 years and of legal age."
Answered by AI
Are researchers presently recruiting participants for this clinical trial?
"Unfortunately, according to clinicaltrials.gov this particular medical trial is not presently accepting patients. The first post was on August 1st 2023 with the last update on May 2nd 2023. However, there are still 328 other trials actively recruiting individuals at this time."
Answered by AI
To what extent are patients eligible to participate in this research?
"To qualify for this medical trial, individuals must experience post-traumatic stress and be between 18 to 65 years of age. This research is seeking 80 participants in total."
Answered by AI
What safety precautions are in place for patients utilizing Mismatch reactivation condition?
"Given that this treatment is approved and registered in a Phase 4 trial, our team at Power has assigned Mismatch reactivation condition with the maximum safety rating of 3."
Answered by AI
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