RecruitingPhase 2NCT06577636

Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder

Efficacy of Anesthesia-induced Dreaming for Post-traumatic Stress Disorder: a Randomized Controlled Trial

Sponsor

Stanford University

Enrollment

42 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

Post Traumatic Stress Disorder PTSD

Summary

The goal of this study is to test whether anesthesia-induced dreaming can help alleviate symptoms of PTSD in an (1) open-label trial (Phase I) and (2) double-blind, randomized controlled trial (Phase II) in a non-surgical setting. The investigators predict that inducing and sustaining a dream state prior to emergence from anesthesia will result in reduced symptoms of PTSD. Participants will undergo EEG-guided propofol anesthesia during which they will be either (1) receiving deep sedation leading to loss of responsiveness, designed to elicit dream reports upon emergence (Dream Protocol), and/or (2) light sedation without loss of responsiveness, designed to elicit non-dream experiential reports while responsive (e.g., simple imagery, sounds, thoughts, bodily sensations, hypnagogic-like experiences) (Non-Dream Protocol). The investigators will then investigate whether the deep-sedation Dream Condition is associated with a larger reduction in PTSD symptoms than the light-sedation Non-Dream Condition.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria8

A subject will be eligible for inclusion when all of the following criteria are met:
Male or female, 18 to 70 years of age
Able to read, understand, and provide written, dated informed consent prior to screening.
Diagnosed with PTSD prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition. The diagnosis of PTSD will be made by a trained study staff member and supported by the Structured Clinical Interview for DSM Disorders (SCID).
Meet the threshold of CAPS-5 score of \>20 during screening.
In sufficiently good health to proceed with a low-risk elective procedure, characterized using the American Society of Anesthesiologists (ASA) physical status classification system as Class I or II.
If female, a status of non-childbearing potential or use of an acceptable form of birth control
Body mass index between 17-35 kg/m2.

Exclusion Criteria19

A potential participant will NOT be eligible for participation if any of the following criteria are met:
Female who is pregnant or breastfeeding.
Total CAPS-5 score ≤20 at either the screening.
Current diagnosis of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe" per criteria of the SCID, or Alcohol Use Disorder rated "moderate" or "severe" per SCID criteria. The following categories of SUD will NOT be excluded: nicotine dependence; alcohol or substance use disorder rated "mild"; alcohol or substance use disorder of any severity in remission, either early (3-12 months) or sustained (\>12 months) time frames.
Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Specific Phobia, or Bipolar II Disorder (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more)
History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.
Any Axis I or Axis II Disorder, which at screening is clinically predominant to their PTSD or has been predominant to their PTSD at any time within six months prior to screening.
In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of his/her participation in the study.
A neurological disorder
A cardiovascular disorder
A pulmonary/respiratory disorder
Clinically significant liver disease
Clinically significant kidney disease
Symptomatic gastroesophageal reflux disease, hiatal hernia, or other gastrointestinal disorder placing patient at risk for aspiration or that would merit categorization of patient as ASA Class III or higher
An endocrine disorder
Any other abnormal laboratory result at the time of the screening exam that in the view of the investigator poses a risk for participation in the study.
If, in the view of the participant's current primary mental health care provider this study poses a risk for participation (if a participant has a current mental health care provider).
Participation in any clinical trial with an investigational drug or device that conflicts with this trial, within the past month or concurrent to study participation.