Anesthesia-Induced Dreaming for PTSD

(IDEA_PTSD Trial)

Overseen By Boris D Heifets, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Disqualifiers: Pregnancy, Substance use disorder, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether certain types of anesthesia, specifically Propofol anesthesia, can reduce PTSD symptoms. Participants will undergo either deep sedation, intended to induce dreams, or light sedation, which prompts simple experiences like sounds or imagery. The trial aims to determine if dreaming during anesthesia provides more relief from PTSD than not dreaming. The study seeks individuals with a PTSD diagnosis who are in good health and can safely undergo a low-risk procedure. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important PTSD research.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that propofol, the anesthesia used in this trial, has mixed safety results. In one study, some patients who received propofol after trauma surgery developed PTSD, suggesting it might affect mental health for certain individuals. Another study found that propofol could strengthen fear memories, which may not be ideal for those with PTSD.

Despite these findings, propofol is commonly used for many medical procedures and is generally well-tolerated. Most people do not experience major side effects. However, these findings highlight potential risks, particularly related to PTSD, underscoring the need for further research. Participants should consider these findings when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the anesthesia-induced dreaming trial for PTSD because it explores a novel approach that taps into the mind's natural dream processes. Unlike traditional PTSD treatments like cognitive behavioral therapy or medication, this method uses propofol anesthesia to potentially trigger therapeutic dream experiences, which could help patients process traumatic memories in a safe and controlled environment. The trial also examines how light sedation might elicit non-dream experiences, offering another unique avenue for understanding and treating PTSD. This innovative protocol could open up new pathways for PTSD treatment, moving beyond the usual focus on conscious therapy sessions.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research suggests that propofol, a drug used for anesthesia, might help with PTSD symptoms. One study found that propofol improved learning and memory in mice with PTSD-like conditions, indicating a potential positive effect. Another study examined dreams during anesthesia and suggested these dreams might reduce PTSD symptoms. In this trial, participants in the Dream Experiences Group will follow a protocol to elicit dream reports, while those in the Non-Dream Experiences Group will follow a protocol for non-dream experiential reports. However, evidence on propofol’s effectiveness for PTSD remains mixed. Some research shows potential benefits, while other findings are less clear. Overall, propofol shows promise, but further research is needed to confirm its benefits for PTSD. ^{1 6 7 8 9}

Who Is on the Research Team?

Boris D Heifets, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with Post-Traumatic Stress Disorder (PTSD). Participants should be healthy enough to undergo anesthesia. Specific details about inclusion and exclusion criteria are not provided, but typically these would outline who can or cannot participate based on health conditions, medications, or other factors.

Inclusion Criteria

I have been diagnosed with PTSD by a professional.

Body mass index between 17-32 kg/m2

I am not able to have children or I am using reliable birth control.

Exclusion Criteria

Total CAPS-5 score ≤20 at screening

Current diagnosis of Axis I disorders other than specified, unless comorbid and clinically unstable, and/or the focus of treatment for the past six months or more

History of anorexia nervosa, bulimia nervosa, or eating disorder within five years of screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (virtual), 1 visit (in-person)

Pre-Anesthesia Assessment

Participants complete daily assessments of sleep quality and dream experiences

2 weeks

Anesthesia Session

Participants undergo EEG-guided infusion of propofol to reach a Dream or No-Dream state

1 day

1 visit (in-person)

Post-Anesthesia Assessment

Participants complete daily assessments of sleep quality and dream experiences

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

4 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Propofol anesthesia

Trial Overview The study is testing if using Propofol anesthesia to induce dreams can help reduce PTSD symptoms. It's a Phase II trial where participants are split into two groups: one experiences induced dreaming ('Dream Group'), while the other does not ('No-Dream group'). The allocation is random and both participants and researchers do not know who is in which group (double-blind).

How Is the Trial Designed?

Group I: Open-label anesthesia protocol Experimental Treatment 1 Intervention

All participants (n = 15) will be subjected to an emergence-from-loss of responsiveness (LOR) protocol intended to elicit dream reports AND to a light sedation without loss of responsiveness protocol intended to elicit non-dream experiential reports while responsive.

Group II: Dream Experiences Group Experimental Treatment 1 Intervention

This group (n=21) will be subjected to an emergence-from-loss of responsiveness (LOR) protocol intended to elicit dream reports.

Group III: Non-Dream Experiences Group Placebo Group 1 Intervention

This Group (n=21) will be subjected to a light sedation without loss of responsiveness protocol, designed to elicit non-dream experiential reports while responsive.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Tiny Blue Dot Foundation

Collaborator

Trials

9

Recruited

640+

Tiny Blue Dot Foundation

Collaborator

Trials

10

Recruited

660+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8914077/

Effects of Sevoflurane and Propofol on Posttraumatic Stress ... In this study, among 281 patients who underwent emergency trauma surgery, 50 (17.8%) developed PTSD 1 month after surgery. The incidence of PTSD in the propofol ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0024320522000492

Propofol improves learning and memory in post-traumatic ... We found that propofol significantly improved the learning ability and memory of mice subjected to PTSD model in the Morris water maze (MWM) and Sucrose ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06577636

Induction of Dreaming With EEG and Anesthesia for Post- ... The investigators predict that inducing and sustaining a dream state prior to emergence from anesthesia will result in reduced symptoms of PTSD.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9469898/

Anesthesia and the Neurobiology of Fear and Post-Traumatic ... There is inconsistent evidence that the use of propofol and benzodiazepines for sedation following trauma may potentiate the development of PTSD relative to ...

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05525-5

Effect of three modalities on emergence agitation among post ... This research aims to compare three different intervention techniques used for avoiding emergence agitation in post-traumatic stress disorder ( ...

6. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.853795/full

Effects of Sevoflurane and Propofol on Posttraumatic ... In this study, among 281 patients who underwent emergency trauma surgery, 50 (17.8%) developed PTSD 1 month after surgery. The incidence of PTSD in the propofol ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01736020

Developing Anesthesia as Post Traumatic Stress Disorder ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2806183

Effect of Dexmedetomidine on Posttraumatic Stress ... Previous studies found that propofol had an unusual reinforcing effect on conditioned fear memory and increased the risk of postoperative PTSD.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0007091217327630

Psychological impact of unexpected explicit recall of events ... Some sedation/RA patients reported an adverse impact on their job performance (15%), family relationships (11%), and friendships (11%), and 15% reported being ...