Is NCT07288151 recruiting in Atlanta, GA?

Yes, NCT07288151 is currently recruiting participants at its Atlanta, GA location. This post traumatic stress disorder clinical trial is actively enrolling qualified participants.

How do I join the post traumatic stress disorder clinical trial in Atlanta?

To join this clinical trial in Atlanta, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Atlanta clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Post Traumatic Stress Disorder Clinical Trial in Atlanta, GA

About This Post Traumatic Stress Disorder Study in Atlanta

The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants. The main questions it aims to answer are: * Does the combination of PE + MDMA lead to greater reduction in PTSD symptom severity from pre-treatment to one-month follow-up compared to PE + placebo? * Does PE + MDMA improve response efficiency and durability of PTSD symptom improvement compared to PE + placebo? * Does MDMA + PE enhance extinction retention and reduce amygdala threat reactivity, and are these changes associated with improved PTSD outcomes? Participants will: * Receive 10 sessions of Massed Prolonged Exposure therapy over two weeks * Be administered either 100 mg of MDMA or a placebo at Visit 2 * Undergo blinded independent evaluator assessments using the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R) at the one-month posttreatment follow-up

Sponsor: Emory University

Who Can Participate

Inclusion Criteria

PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale for DSM-5 - Revised (CAPS-5-R).

Able to speak and read English (due to standardization of outcome measures).

Willing to sign a release for the investigators to communicate with their primary care or mental health providers if indicated.

Able to swallow pills.

Agree to have study visits video and/or audio recorded, including Experimental Session, assessments, and non-drug therapy sessions.

Willing to provide a contact (relative, spouse, close friend, or another support person) who is willing and able to be contacted by the investigators.

Agree to inform the investigators within 48 hours of any medical conditions and procedures.

If able to become pregnant, must have a negative pregnancy test before study entry, at study entry, and before the Medicine Session. Must agree to use adequate birth control for a month before the Medicine session and through 10 days after the Medicine Session.

Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications before the Medicine Session, and not participating in any other interventional clinical trials during the duration of the study, are driven home or to a hotel after the Medicine Session, and commit to medication dosing, therapy, and study procedures

Exclusion Criteria

Are not able to give adequate informed consent.

Have previously participated in a Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored MDMA clinical trial.

Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation.

Have hypersensitivity to any ingredient of the Investigational Medicinal Product (IMP).

Upon review of medical or psychiatric history and psychiatric assessment, have any current or past diagnosis that would be considered a risk to participating in the study

Requires ongoing psychiatric medication use with certain exceptions. Individuals may decide to taper psychiatric medications under the guidance of their local provider.

Have a history of any medical condition that could make receiving MDMA dangerous because of increases in blood pressure and heart rate or any medical condition the study physician believes would pose a safety risk or interfere with the effects of the treatment. Any medical disorder judged by the investigator to significantly increase the risk of MDMA administration by any mechanism is exclusionary.

Have any unstable medical condition that would interfere with participation.

Have uncontrolled hypertension) documented on three separate occasions.

Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.

Have a history of ever having ventricular arrhythmia or any other abnormal heart rhythm that the study physician believes would pose a significant risk of participation.

Have an abnormal finding on electrocardiogram

Have a history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).

Require the use of concomitant medications that could impact the effects or safety of MDMA during the Medicine Session.

Have symptomatic liver disease or significant liver enzyme elevations.

Have a history of hyponatremia or hyperthermia.

Weigh less than 48 kilograms (105 lbs.).

Are pregnant or nursing

Have engaged in ketamine-assisted therapy or used ketamine within 12 weeks of enrollment

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Atlanta?

Yes, this clinical trial (NCT07288151) has an active research site in Atlanta, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Post Traumatic Stress Disorder Treatment Options in Atlanta, GA

If you're searching for post traumatic stress disorder treatment options in Atlanta, GA, this clinical trial (NCT07288151) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Atlanta research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced post traumatic stress disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all post traumatic stress disorder clinical trials near you to find additional studies recruiting in your area.

Post Traumatic Stress Disorder Clinical Trial in Atlanta, GA

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