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MDMA-Assisted Psychotherapy for PTSD

Phase 2

Recruiting

Led By Paul Uy, MD

Research Sponsored by Remedy

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are able to swallow pills

Are at least 18 years old

Must not have

Are not able to give adequate informed consent

Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the benefits of combining MDMA-assisted Cognitive-Behavioral Conjoint Therapy with the treatment of Post-Traumatic Stress Disorder (PTSD). The study will look at the safety, feasibility, acceptability, and effectiveness of the combination.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

MDMA may cause side effects like anxiety, changes in mood, confusion, headaches, increased heart rate and blood pressure issues. Long-term risks include potential substance use disorder related to MDMA.

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 am 18 years old or older.

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I am willing to stop taking all my current medications, including psychiatric and herbal supplements, for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand or sign the consent form.

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I have an underactive thyroid and am not taking medication for it.

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I have liver disease that is causing symptoms.

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I have had low sodium levels in my blood.

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I have had episodes of dangerously high body temperature.

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I have major depression with psychotic symptoms.

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I have recently undergone Electroconvulsive Therapy (ECT).

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My type 2 diabetes is considered unstable by my doctor.

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I have high blood pressure or a history of heart problems.

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I weigh less than 48 kg.

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I do not have a history of conditions like glaucoma, heart issues, or stroke.

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I am currently taking medication for a mental health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinician Administered PTSD Scale (CAPS-5)

Feasibility of Intervention Measure (FIM)

Intervention Appropriateness Measures (IAM)

+2 more

Secondary study objectives

Couple Satisfaction Index (CSI)

Patient Health Questionnaire-9 (PHQ-9)

Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5)

+1 more

Other study objectives

Alcohol Use Disorders Identification Test (AUDIT), Cannabis Use Disorders Identification Test-Revised (CUDIT-R), and Drug Use Disorders Identification Test (DUDIT)

Brief Experiential Avoidance Questionnaire (BEAQ)

Brief Posttraumatic Cognitions Inventory (PTCI-9)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 15Eligibility criteria met