MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD (VALLMDMA_001)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04264026|
Recruitment Status : Not yet recruiting
First Posted : February 11, 2020
Last Update Posted : February 12, 2020
This will be a single-site, open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA. MDMA will be given in conjunction with structured psychotherapy in three single-dose psychotherapy sessions in a hospital setting over the course of 12 weeks, along with preparatory and integration psychotherapy sessions in-between each active-dose session. The overall objective of this study is to evaluate the risks, benefits, and feasibility of MDMA used in conjunction with manualized psychotherapy, on reduction of symptoms, or remission of PTSD, as evaluated by standard clinical measures, in a VA Healthcare System.
The primary outcome measure for the study is the Clinician-Administered PTSD Scale (CAPS-5), a semi-structured interview used in the majority of clinical trials for PTSD, which will be assessed at baseline, primary endpoint, and at the long-term 12-month follow-up visit. Secondary safety and efficacy measures will also be collected.
The planned duration of this study is 1-3 years, with each active treatment period lasting approximately 12 weeks, along with a long-term follow-up 12 months after the last active-drug session.
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder Combat Stress Disorders||Drug: 3,4-methylenedioxymethamphetamine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-site, open-label study|
|Masking:||None (Open Label)|
|Official Title:||Open-label Phase 2 Study of MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Open Label
Participants will receive an initial dose of 80 mg of 3,4-methylenedioxymethamphetamine (MDMA) and an optional supplemental dose of 40 mg MDMA during the first Experimental Session. In the second and third Experimental Sessions, the participant will receive an initial dose of 120 mg MDMA and an optional supplemental dose of 60 mg MDMA.
Bottles are labeled with a unique container number, protocol number, IMP name, lot number, sponsor name and a statement that the IMP is restricted to clinical trial use only.
Other Name: MDMA
- Change in total score of CAPS-5 [ Time Frame: baseline, 2 months, 12-months follow-up ]CAPS-5 is the gold standard measurement tool for evaluating PTSD in current FDA-approved medication trials for PTSD. The CAPS-5 is a standardized method to evaluate the frequency and intensity dimensions of each PTSD symptom, impact on functioning, overall severity of the symptom complex, and a dichotomous outcome based on DSM-5 criteria on whether the participant meets diagnostic criteria for PTSD. CAPS-5 scores will be measured at baseline, 2 months after the last drug session, and at the long-term 12-month follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264026
|Contact: Angela J Hawley, MA||909-825-7084 ext email@example.com|
|Contact: Allie Kaigle, PharmD, BCPPfirstname.lastname@example.org|
|United States, California|
|VA Loma Linda Health Care System|
|Loma Linda, California, United States, 92357|
|Contact: Angela J Hawley, MA 909-825-7084 ext 2411 email@example.com|
|Contact: Maria I Rodriguez 909-825-7084 ext 6159 firstname.lastname@example.org|
|Principal Investigator: Shannon Remick, MD|
|Sub-Investigator: Allie Kaigle, PharmD, BCPP|
|Principal Investigator:||Shannon Remick, MD||Staff Psychiatrist|