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MDMA for PTSD and Alcoholism (MDMA Trial)
Phase 2
Recruiting
Research Sponsored by Carolina L 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
Must not have
Diagnosis of controlled or uncontrolled hypertension
History of seizures or delirium tremens (DTs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to post-treatment follow up (18 weeks)
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have high blood pressure.
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I have had seizures or delirium tremens.
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I have had irregular heartbeats from the lower chambers of my heart.
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I am currently diagnosed with major depression that includes hallucinations or delusions.
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I have Wolff-Parkinson-White syndrome or a similar condition not fixed by ablation.
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I have had a condition where my lymphocytes grow abnormally.
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I have a history of cancer.
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I have liver problems or high liver enzyme levels.
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My liver condition is stable.
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I have a condition that makes taking stimulant medications unsafe.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to post-treatment follow up (18 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to post-treatment follow up (18 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CAPS score reduction
Number of standard unit drinks form the TLFB
Secondary study objectives
Safety and tolerability
Side effects data
From 2018 Phase 1 & 2 trial • 12 Patients • NCT0287617233%
Anxiety
17%
Insomnia
17%
Visual Impairment
17%
Vomiting
17%
Upper respiratory tract infection
17%
Arthropod bite
17%
Disturbance in attention
17%
Dizziness
17%
Paresthesia
17%
Nasal congestion
17%
Dyspnoea
17%
Oropharyngeal pain
17%
Rhinorrhoea
17%
Pruritis
17%
Rash
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)
PTSD Patients at 6-month Follow-up
CSO Patients at 6-month Follow-up
PTSD Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2023
Completed Phase 2
~420
Find a Location
Who is running the clinical trial?
Carolina L Haass-KofflerLead Sponsor
Carolina Haass-KofflerLead Sponsor