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MDMA-AT for Post-Traumatic Stress Disorder (MDMA Trial)

Phase 2
Recruiting
Research Sponsored by Carolina Haass-Koffler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to swallow pills
Have a confirmed PTSD diagnosis per the CAPS-5 and a Total Severity Score of 28 or greater at Baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to post-treatment follow up (18 weeks)
Awards & highlights

MDMA Trial Summary

This trial is the first of its kind to test the effects of MDMA-assisted therapy on military veterans who have both Alcohol Use Disorder and Post-Traumatic Stress Disorder. The treatment involves therapy sessions combined

Who is the study for?
This trial is for military veterans who have both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). Participants must be fluent in English, able to prove veteran status, meet specific criteria for AUD and PTSD with a certain severity of symptoms, can abstain from alcohol safely for 48 hours without medical detox, are capable of swallowing pills, and agree to recorded study visits. They also need a contact person available for emergencies.Check my eligibility
What is being tested?
The trial is testing MDMA-assisted therapy as a new treatment approach for veterans with AUD/PTSD comorbidity. It involves two monthly sessions where therapy is combined with divided doses of MDMA HCl. The main focus is on changes in alcohol use over time and improvements in PTSD symptoms.See study design
What are the potential side effects?
While not explicitly listed here, common side effects associated with MDMA may include anxiety, headache, fatigue, muscle tension or cramps, nausea or upset stomach during the experimental sessions.

MDMA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow pills.
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I have been diagnosed with PTSD and my symptoms are severe.
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I am not pregnant, not planning a pregnancy, not breastfeeding, and I follow birth control guidelines.

MDMA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to post-treatment follow up (18 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to post-treatment follow up (18 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CAPS score reduction
Number of standard unit drinks form the TLFB
Secondary outcome measures
Safety and tolerability

Side effects data

From 2018 Phase 1 & 2 trial • 12 Patients • NCT02876172
33%
Anxiety
17%
Nasal congestion
17%
Rash
17%
Dyspnoea
17%
Visual Impairment
17%
Vomiting
17%
Upper respiratory tract infection
17%
Arthropod bite
17%
Disturbance in attention
17%
Paresthesia
17%
Oropharyngeal pain
17%
Pruritis
17%
Dizziness
17%
Insomnia
17%
Rhinorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
CSO Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
CSO Patients at 6-month Follow-up
PTSD Patients at 6-month Follow-up
PTSD Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)

MDMA Trial Design

1Treatment groups
Experimental Treatment
Group I: MDMA-ATExperimental Treatment1 Intervention
Participant will receive MDMA administration with assisted therapy (AT) by trained clinicians
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MDMA
2001
Completed Phase 2
~390

Find a Location

Who is running the clinical trial?

Carolina Haass-KofflerLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities for potential participants to enroll in this trial?

"According to the details available on clinicaltrials.gov, this current trial is actively seeking volunteers. The initial posting of this research study was on February 6th, 2024, with the most recent update being on February 7th, 2024."

Answered by AI

What is the aggregate count of individuals currently enrolled in this clinical investigation?

"Indeed, the information on clinicaltrials.gov shows that this study is actively seeking individuals to participate. The trial was initially listed on February 6th, 2024, with the most recent update made on February 7th, 2024. It aims to enroll a total of 18 participants from one designated site."

Answered by AI

What are the safety implications of utilizing MDMA-assisted therapy for individuals undergoing treatment?

"In view of this being a Phase 2 clinical trial, our team at Power gauges the safety rating of MDMA-AT to be 2 due to existing data supporting its safety profile but lacking evidence on efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Brown University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
MDMA for AUD/PTSD Comorbidity
Carolina Haass-Koffler 2024. "MDMA for AUD/PTSD Comorbidity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05943665.
All > Ptsd Boston
~12 spots leftby Jan 2025
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