PTSD study: Propofol
Official title Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder
ClinicalTrials.gov ID: NCT06577636
What this study is testing
What is Propofol?
An investigational intravenous anesthetic being studied as a potential treatment for PTSD. It is designed to enhance GABA activity in the brain, producing sedation and altering consciousness.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a dream‑like experience after anesthesia reduces PTSD symptoms more than a non‑dream experience.
- Who it's for
- You may be able to join if you have PTSD and can safely have anesthesia.
- What's involved
- You will receive a short anesthesia while a brain monitor records activity. You may have a dream or not, and you will fill out symptom questionnaires.
- Time commitment
- The session lasts a few hours and you will return for later check‑ins.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
- Meet the threshold of CAPS-5 score of \>20 during screening.
- Concurrent psychotherapy will be allowed if the type (e.g., supportive, cognitive behavioral, insight-oriented, et al) and frequency (e.g., weekly or...
You likely can't join if
- Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
- Female who is pregnant or breastfeeding.
- Female with a positive pregnancy test on the day of, and prior to, the anesthesia session.
- Total CAPS-5 score ≤20 at either the screening.
- Current diagnosis or a recent history (within 2 years) of a Substance Use Disorder (SUD
- History of schizophrenia or schizoaffective disorders, or a psychotic disorder as defined by QuickSCID-5 interview.
See the full eligibility criteria
- 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.
- Meet the threshold of CAPS-5 score of \>20 during screening.
- Concurrent psychotherapy will be allowed if the type (e.g., supportive, cognitive behavioral, insight-oriented, et al) and frequency (e.g., weekly or monthly) of the therapy has been stable for at least 4 weeks prior to...
- Concurrent antidepressant therapy (e.g. SSRI or SNRI) will be allowed if the therapy has been stable for at least 4 weeks prior to screening, and if it is expected to remain stable during the course of the subject's...
- 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, or III.
- 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.
- Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
- Female who is pregnant or breastfeeding.
- Female with a positive pregnancy test on the day of, and prior to, the anesthesia session.
- Total CAPS-5 score ≤20 at either the screening.
- Current diagnosis or a recent history (within 2 years) of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe" per criteria of the QuickSCID-5, or Alcohol Use Disorder...
- History of schizophrenia or schizoaffective disorders, or a psychotic disorder as defined by QuickSCID-5 interview.
- History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.
- Any DSM-5 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.
- Has abnormality on the screening physical examination that might affect safety, study participation or confound interpretation of study results, including any condition that would merit categorization of patient as ASA...
- Has a positive urine drug screen on the day of the anesthesia session.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Stanford, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.