60 Participants Needed

MDMA-Assisted Psychotherapy for PTSD

AC
HA
SG
AW
Overseen ByAnne Wagner, C.Psych.
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This study aims to evaluate the safety, feasibility, acceptability, and effectiveness of MDMA-assisted Cognitive-Behavioral Conjoint Therapy (CBCT) versus CBCT alone for the treatment of Post-Traumatic Stress Disorder (PTSD). PTSD is a debilitating condition that significantly impacts interpersonal relationships and the functioning of individuals and their loved ones. There is also a well-established reciprocal relationship between interpersonal relationships, PTSD, and recovery. CBCT is a manualized treatment for PTSD that simultaneously addresses PTSD symptoms and relationship satisfaction. It provides dyads with behavioral tools to navigate PTSD-related challenges, as well as the knowledge behind PTSD and how it impacts relationships. Previous research has demonstrated the efficacy of CBCT in improving PTSD symptoms, partner functioning, and relationship satisfaction in both distressed and non-distressed dyads. MDMA is a drug commonly used recreationally that has been increasingly studied because of its ability to reduce the impact of PTSD symptoms. The effects of MDMA are reduced fear, enhanced communication, trust and introspection, and increased empathy and compassion. The effects of MDMA create a state that enhances the positive effects of therapy by increasing the ability to tolerate negative emotions and allowing clients to stay engaged in therapy without being overwhelmed by the intense emotions surrounding the memories of traumatic events. It is believed that MDMA may help promote the effects of CBCT due to its ability to induce empathy and interpersonal openness. This randomized study is the second study designed to explore the efficacy of combining MDMA-assisted therapy with CBCT. This study will enroll 30 dyads, where one individual has symptoms of PTSD. Participants will undergo a 7-week psychotherapy course, in MDMA-assisted CBCT or CBCT alone. In the MDMA-assisted CBCT, participants will go through CBCT sessions, and two doses of MDMA will be used as an adjunct to psychotherapy. Participants assigned to the CBCT-only condition will go through CBCT sessions and will have the opportunity to crossover and receive the two MDMA sessions after follow-up. The primary goal of this research is to contribute to the literature on MDMA-assisted CBCT by investigating its feasibility, safety, acceptability, and effectiveness, and by comparing it to active PTSD treatments.

Will I have to stop taking my current medications?

Yes, participants must stop taking psychiatric medications, herbal supplements, and both prescription and nonprescription medications during the study.

What data supports the effectiveness of the drug MDMA in treating PTSD?

Research shows that MDMA-assisted therapy can significantly reduce PTSD symptoms, with one study reporting an 83% response rate in patients who had not improved with other treatments. Additionally, MDMA has been shown to enhance the effects of cognitive-behavioral conjoint therapy, improving PTSD symptoms, depression, sleep, and relationship satisfaction.12345

Is MDMA-assisted psychotherapy safe for humans?

MDMA-assisted psychotherapy has been studied for safety, and while it can increase blood pressure, heart rate, and body temperature, no serious adverse events were reported in a study with PTSD patients. Efforts to limit the conversion of MDMA to reactive metabolites may improve its safety profile.16789

How is MDMA-assisted psychotherapy different from other PTSD treatments?

MDMA-assisted psychotherapy is unique because it uses MDMA (commonly known as Ecstasy) to enhance the effectiveness of psychotherapy, helping patients process trauma more effectively. This approach is particularly promising for those with treatment-resistant PTSD, as it has shown significant improvements in symptoms compared to traditional therapies.1231011

Research Team

PU

Paul Uy, MD

Principal Investigator

Remedy Institute

AW

Anne Wagner, PhD

Principal Investigator

Remedy Institute

Eligibility Criteria

This trial is for adults with PTSD in the Greater Toronto Area who are willing to stop taking certain medications and agree to study rules. Participants must be healthy, able to swallow pills, proficient in English, and have a supportive person willing to join the study. Pregnant individuals or those at risk of becoming pregnant without contraception are excluded.

Inclusion Criteria

You are an Ontario resident residing in the Greater Toronto Area.
You possess fluency in both spoken and written English.
You have consented to the study's regulations and are willing to attend all medical and treatment appointments.
See 14 more

Exclusion Criteria

I am unable to understand or sign the consent form.
I have an underactive thyroid and am not taking medication for it.
I can follow the study's schedule and rules.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 7-week course of CBCT psychotherapy, with the MDMA-assisted group receiving two MDMA sessions as an adjunct to therapy

7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including self-compassion, social support, PTSD symptoms, and relationship satisfaction

3 months

Crossover (optional)

Participants in the CBCT-only condition have the option to crossover and receive two MDMA sessions after follow-up

Treatment Details

Interventions

  • CBCT
  • CBCT RCT
  • MDMA-Assisted CBCT for PTSD
Trial OverviewThe trial tests MDMA-assisted Cognitive-Behavioral Conjoint Therapy (CBCT) against CBCT alone for PTSD treatment. It explores whether MDMA's effects on empathy and openness can enhance CBCT's impact on symptoms and relationship satisfaction over a 7-week course with two full-day sessions.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: MDMA-Assisted CBCT ConditionExperimental Treatment1 Intervention
Dyads will undergo a 7-week course of CBCT psychotherapy for PTSD with two sessions that integrate MDMA-assisted psychotherapy. MDMA will be administered in two separate sessions and integrated into the psychotherapy protocol. The two doses of MDMA during this study will be used as an adjunct to psychotherapy.
Group II: CBCT-Only ConditionActive Control1 Intervention
Dyads will undergo a 7-week course of CBCT psychotherapy for PTSD. Dyads who have undergone the CBCT-Only condition will have the option to do a crossover and have the two MDMA sessions after follow-up.

CBCT is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as MDMA for:
  • Post-Traumatic Stress Disorder (PTSD) - Investigational
🇪🇺
Approved in European Union as MDMA for:
  • Post-Traumatic Stress Disorder (PTSD) - Investigational

Find a Clinic Near You

Who Is Running the Clinical Trial?

Remedy

Lead Sponsor

Trials
3
Recruited
220+

Remedy Institute

Collaborator

Trials
1
Recruited
60+

Findings from Research

In a study involving six couples where one partner had PTSD, MDMA-facilitated cognitive-behavioral conjoint therapy (CBCT) showed significant improvements in PTSD symptoms and relationship satisfaction, with effect sizes ranging from 1.85 to 3.59.
The treatment was safe and well-tolerated, with no serious adverse events reported, suggesting that MDMA can enhance the effectiveness of therapy for both individual and relational functioning in PTSD cases.
MDMA-facilitated cognitive-behavioural conjoint therapy for posttraumatic stress disorder: an uncontrolled trial.Monson, CM., Wagner, AC., Mithoefer, AT., et al.[2021]
MDMA-assisted psychotherapy shows significant reductions in PTSD symptoms, as measured by the Clinician Administered PTSD Scale (CAPS-IV), particularly at doses of 75 mg and 125 mg, based on a meta-analysis of four randomized controlled trials involving treatment-resistant PTSD patients.
While MDMA treatment was associated with some adverse effects like low mood and nausea, the overall risk was minimal, suggesting that MDMA could be a promising option for patients who have not responded to traditional therapies.
A comparison of MDMA-assisted psychotherapy to non-assisted psychotherapy in treatment-resistant PTSD: A systematic review and meta-analysis.Illingworth, BJ., Lewis, DJ., Lambarth, AT., et al.[2022]
In a clinical trial involving 20 patients with chronic PTSD who had not responded to other treatments, those receiving MDMA during psychotherapy showed a significantly greater reduction in PTSD symptoms compared to the placebo group, with an 83% response rate in the MDMA group versus 25% in the placebo group.
MDMA-assisted psychotherapy was found to be safe, with no serious adverse events or negative effects on neurocognitive function, suggesting it could be a beneficial treatment option for patients with treatment-resistant PTSD.
The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study.Mithoefer, MC., Wagner, MT., Mithoefer, AT., et al.[2021]

References

MDMA-facilitated cognitive-behavioural conjoint therapy for posttraumatic stress disorder: an uncontrolled trial. [2021]
A comparison of MDMA-assisted psychotherapy to non-assisted psychotherapy in treatment-resistant PTSD: A systematic review and meta-analysis. [2022]
The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. [2021]
Potential Psychiatric Uses for MDMA. [2018]
3,4-Methylenedioxymethamphetamine's (MDMA's) Impact on Posttraumatic Stress Disorder. [2019]
In vivo effects of 3,4-methylenedioxymethamphetamine (MDMA) and its deuterated form in rodents: Drug discrimination and thermoregulation. [2021]
3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial. [2019]
Prevalence and Correlates of Past Year Ecstasy/MDMA Use in the United States. [2023]
A clinical plan for MDMA (Ecstasy) in the treatment of posttraumatic stress disorder (PTSD): partnering with the FDA. [2013]
MDMA-assisted psychotherapy for people diagnosed with treatment-resistant PTSD: what it is and what it isn't. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
A randomized, controlled pilot study of MDMA (± 3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD). [2013]