Dose Optimization of MDMA-Assisted Therapy for PTSD

Status Not yet recruiting

Clinical Trial Summary

This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.

Clinical Trial Description

This open label, within-subjects dose optimization study will determine the optimal number of treatment cycles of MDMA-AT (one cycle consists of one Experimental Session followed by three Integrative Sessions) for significant improvement in a sample of U.S. veterans with PTSD. All participants will receive three non-drug preparatory sessions and at least one cycle of MDMA-assisted therapy with a team of two therapists. Each cycle will consist of one approximately 8-hour drug session followed by three 90-minute non-drug integrative sessions. After each cycle, participants will determine, in consultation with their therapy team, whether to continue with an additional cycle or to discontinue treatment. The decision will reflect the participant's perception of the potential for continued improvement (e.g., as based on current symptom burden, treatment response to date) weighed against the burden of an additional cycle (e.g., time required, any adverse events or emotional burden). Participants may complete up to a maximum of five cycles. The dose optimizing design allows for the identification of the optimal number of MDMA-AT cycles to achieve the best response and to assess tolerability of multiple cycles of MDMA-AT. Participants will also provide blood samples to be banked for future analysis of biological markers associated with treatment response. For each participant, the study will consist of: - Screening Period: initial screen, informed consent, eligibility assessment - Enrollment Period with Enrollment Confirmation: Enrollment and medication tapering period (if needed) followed by psychological assessment and Enrollment Confirmation, collection of biomarker blood samples. - Treatment Period: 3 Preparatory sessions; one to five Experimental Sessions, each followed by 3 non-drug Integrative Sessions and a follow-up visit with study therapists - Post-treatment Period and Study Termination: Psychological Evaluation, biomarker blood samples, study termination visit ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06418178
Study type	Interventional
Source	Bronx VA Medical Center
Contact	Amy Lehrner, PhD
Phone	718-584-9000
Email	Amy.Lehrner@va.gov
Status	Not yet recruiting
Phase	Phase 2
Start date	October 2024
Completion date	October 2029

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Dose Optimization of MDMA-Assisted Therapy for PTSD — DosOp

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms