MDMA-Assisted Therapy for PTSD
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding MDMA (a psychoactive drug) to therapy can better assist people with PTSD compared to therapy alone. Participants will undergo therapy sessions and receive either MDMA or a placebo to assess effectiveness. The trial will evaluate whether this combination reduces PTSD symptoms more effectively and for a longer duration than therapy alone. Individuals diagnosed with PTSD who can manage daily activities, such as swallowing pills and attending therapy sessions, might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that MDMA-assisted therapy is generally safe. In one study, 83% of participants who took MDMA responded positively, with no serious drug-related side effects. Another study found that this therapy reduced PTSD symptoms and improved daily functioning in a diverse group. It demonstrated a high rate of improvement and recovery without major safety issues. These findings suggest that MDMA, when used in a controlled setting with therapy, is safe for most people.12345
Why do researchers think this study treatment might be promising for PTSD?
Unlike traditional treatments for PTSD, which often involve antidepressants or psychotherapy, MDMA-assisted therapy takes a unique approach by combining the psychoactive effects of MDMA with therapeutic sessions. MDMA, commonly known for its use in recreational settings, enhances empathy and emotional openness, which can help patients process traumatic memories more effectively during therapy. Researchers are excited about this treatment because it targets the emotional and psychological barriers that often hinder progress in traditional therapy, potentially leading to faster and more profound healing.
What evidence suggests that MDMA-assisted therapy might be an effective treatment for PTSD?
Research has shown that therapy using MDMA, which participants in this trial may receive, can greatly reduce PTSD symptoms. Studies have found that many participants who took MDMA experienced fewer symptoms and often saw significant improvement. For example, one study noted a significant drop in PTSD symptoms a year after full-dose MDMA treatment. Another small study that combined MDMA with Massed Exposure Therapy also showed large reductions in symptoms. Overall, these findings suggest that MDMA could be an effective treatment for PTSD.23467
Who Is on the Research Team?
Jessica Maples-Keller, PhD
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
This trial is for adults with PTSD. Participants will undergo intense therapy sessions over two weeks and must be diagnosed with PTSD to join. People can't participate if they have certain medical conditions or are taking drugs that would interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 10 sessions of Massed Prolonged Exposure therapy over two weeks, with either 100 mg of MDMA or a placebo administered at Visit 2
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments using the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R)
What Are the Treatments Tested in This Trial?
Interventions
- MDMA
Trial Overview
The trial tests whether MDMA combined with Massed Prolonged Exposure therapy is more effective in reducing PTSD symptoms than a placebo combined with the same therapy. It measures symptom severity, treatment efficiency, and changes in brain response to threats.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
United States Department of Defense
Collaborator
Citations
MDMA-assisted therapy for moderate to severe PTSD
These data suggest that MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well ...
assisted psychotherapy for post-traumatic stress disorder in ...
PTSD symptoms were significantly reduced at the 12-month follow-up compared with baseline after all groups had full-dose MDMA (mean CAPS-IV total score of 38·8 ...
assisted psychotherapy for posttraumatic stress disorder: A ...
MDMA-assisted psychotherapy demonstrated a high rate of clinical response (RR = 3.47, 95% CI: 1.70, 7.06), remission (RR = 2.63, 95% CI: 1.37, 5.02), with a ...
MDMA-Assisted Massed Exposure Therapy for PTSD
Early results from a pilot study suggest this combination may lead to large reductions in PTSD symptoms. This is the first clinical trial to ...
PTSD_Draft-Report_For-Publication_03262024.pdf
The Efficacy of MDMA (3,4-. Methylenedioxymethamphetamine) for Post-traumatic Stress Disorder in Humans: A Systematic Review and Meta ...
the first randomized controlled pilot study
The rate of clinical response was 10/12 (83%) in the active treatment group versus 2/8 (25%) in the placebo group. There were no drug-related serious adverse ...
3,4-methylenedioxymethamphetamine (MDMA)-assisted ...
PTSD symptoms were significantly reduced at the 12-month follow-up compared with baseline after all groups had full-dose MDMA (mean CAPS-IV ...
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