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

Trial Summary

What is the purpose of this trial?

The goal of this study is to test the efficacy of anesthesia-induced dreaming for PTSD in a double-blind, randomized controlled trial in a non-surgical setting (Phase II). The investigators predict that inducing and sustaining a dream state prior to emergence from anesthesia will result in reduced symptoms of PTSD. Half of the participants will be randomly allocated to a Dream Group, while the other half will be in the No-Dream group.

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.

What data supports the effectiveness of the drug Propofol anesthesia for PTSD?

A case report suggests that Propofol anesthesia, which often causes dreaming, may help with stress disorders, as one patient experienced vivid dreaming and remission of acute stress disorder after surgery. ^{1 2 3 4 5}

Is propofol anesthesia safe for inducing dreams in humans?

Propofol anesthesia is generally considered safe for inducing dreams, as it is commonly used in medical procedures like endoscopies and surgeries. Studies have shown that dreaming is a frequent side effect, but the dreams are usually pleasant and there are no significant safety concerns reported in the research. ^{1 2 6 7 8}

How is the drug Propofol anesthesia unique for treating PTSD?

Propofol anesthesia is unique for treating PTSD because it involves inducing a dream-like state during sedation, which may help patients process traumatic memories in a controlled environment. This approach is different from traditional PTSD treatments, as it leverages the anesthetic state to potentially facilitate psychological healing through dreaming. ^{1 2 3 9 10}

Research Team

Boris D Heifets, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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)

Treatment Details

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).

Participant Groups

Group I: Dream Group Active Control 1 Intervention

Dream Group (n=21) will be subjected to an anesthetic protocol resulting in dream experiences during anesthesia.

Group II: No-Dream Group Placebo Group 1 Intervention

No-Dream Group (n=21) will be subjected to an anesthetic protocol resulting in no dream experiences during anesthesia.

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Anesthetic-Induced Intraoperative Dream Associated With Remission of a Psychiatric Disorder: A Case Report. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Propofol dose and incidence of dreaming during sedation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Awareness during anesthesia and posttraumatic stress disorder. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The incidence of awareness during anesthesia: a multicenter United States study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Emergence Delirium With Post-traumatic Stress Disorder Among Military Veterans. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Bispectral Index Monitoring and Observer Rating Scale Correlate with Dreaming during Propofol Anesthesia for Gastrointestinal Endoscopies. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The safe and effective use of propofol sedation in children undergoing diagnostic and therapeutic procedures: experience in a pediatric ICU and a review of the literature. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Sevoflurane and Propofol on Posttraumatic Stress Disorder After Emergency Trauma: A Double-Blind Randomized Controlled Trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Dreaming in sedation during spinal anesthesia: a comparison of propofol and midazolam infusion. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Anesthesia awareness: narrative review of psychological sequelae, treatment, and incidence. [2021]