EEG‑guided propofol to induce dreaming as a therapy for PTSD

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

This trial will test whether EEG‑guided propofol anesthesia that induces dreaming can reduce symptoms in adults with PTSD.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 1 site (Stanford, California)
• Trial ID: NCT06577636 on ClinicalTrials.gov

What this trial studies

The study uses EEG‑guided propofol anesthesia in a non‑surgical setting across two phases: an open‑label Phase I (N=15) and a double‑blind, randomized Phase II (N=42). Participants receive either a deep‑sedation 'Dream' protocol designed to elicit dream reports on emergence or a light‑sedation 'Non‑Dream' protocol designed to elicit non‑dream experiential reports while responsive. PTSD symptom change is measured with standardized instruments including the CAPS‑5 and PCL‑5 before and after the intervention. Phase II is sham‑controlled and blinded to isolate any specific therapeutic effect of induced dreaming.

Who should consider this trial

Good fit: Adults 18–70 years with a confirmed PTSD diagnosis, CAPS‑5 score >20, BMI 17–35 kg/m2, low anesthetic risk (ASA I–II), and the ability to provide informed consent are ideal candidates.

Not a fit: People who are medically unfit for anesthesia, pregnant or without acceptable contraception if of childbearing potential, outside the specified age or BMI ranges, or unable to consent are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could offer a new, rapid option to reduce PTSD symptoms by promoting therapeutic dreaming around anesthesia.

How similar studies have performed: There is preliminary evidence that dreaming during anesthesia may reduce PTSD symptoms, but larger randomized trials are limited and definitive efficacy remains unproven.

Eligibility criteria

Inclusion Criteria:

A subject will be eligible for inclusion when all of the following criteria are met:

1. Male or female, 18 to 70 years of age
2. Able to read, understand, and provide written, dated informed consent prior to screening.
3. 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).
4. Meet the threshold of CAPS-5 score of \>20 during screening.
5. 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.
6. If female, a status of non-childbearing potential or use of an acceptable form of birth control
7. Body mass index between 17-35 kg/m2.

Exclusion Criteria:

A potential participant will NOT be eligible for participation if any of the following criteria are met:

1. Female who is pregnant or breastfeeding.
2. Total CAPS-5 score ≤20 at either the screening.
3. 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.
4. 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)
5. History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
6. History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.
7. 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.
8. 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.
9. A neurological disorder
10. A cardiovascular disorder
11. A pulmonary/respiratory disorder
12. Clinically significant liver disease
13. Clinically significant kidney disease
14. 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
15. An endocrine disorder
16. 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.
17. 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).
18. 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.

Where this trial is running

Stanford, California

• Stanford University — Stanford, California, United States (Recruiting)

Study contacts

• Principal investigator: Boris D Heifets, MD, PhD — Stanford University
• Study coordinator: Boris D Heifets, MD, PhD

Conditions PTSD; Post-traumatic Stress Disorder; anesthesia; propofol; post-traumatic stress disorder; dreaming; dreams