Status:
RECRUITING
Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Tiny Blue Dot Foundation
Conditions:
PTSD
Post-traumatic Stress Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
GENERAL BACKGROUND Post-traumatic stress disorder (PTSD) affects millions of Americans, and it can make everyday life very challenging. PTSD is characterized by recurrent distressing memories and nig...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06577636
Start Date
July 21 2025
End Date
December 1 2026
Last Update
September 25 2025
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305