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Psychedelic

MDMA Assisted Therapy for PTSD and Opioid Use Disorder

Phase 2

Waitlist Available

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

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

Must have

Female participants must have a negative pregnancy test at study entry and agree to use adequate birth control

Participants must have opioid use disorder and be using daily oral methadone of 180 mg or less, or sublingual buprenorphine of 24 mg or less, and assessed as stable for at least 3 months

Must not have

Participants unable to give adequate informed consent

Participants with medical history including conditions that could make receiving sympathomimetic drugs harmful, uncontrolled essential hypertension, history of ventricular arrhythmia, arrhythmia within 12 months, additional risk factors for Torsade de pointes, use of concomitant medications that prolong QT/QTc interval, symptomatic liver disease, significant liver enzyme elevations, history of hyponatremia or hyperthermia, weight less than 48 kg, and pregnancy without effective birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks after 3rd experimental session

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the use of MDMA Assisted Therapy for postpartum individuals who have both Post Traumatic Stress Disorder (PTSD) and Opioid Use Disorder (OUD). The

Who is the study for?

This trial is for postpartum individuals at least 18 years old with PTSD and OUD, using a stable dose of methadone or buprenorphine. Participants must speak English, be able to swallow pills, consent to recorded sessions, provide an emergency contact, inform investigators about medical changes, and use effective birth control if applicable.

What is being tested?

The study tests MDMA Assisted Therapy's feasibility and safety in treating PTSD in those with OUD after childbirth. It adapts from Phase 3 studies by MAPS for PTSD treatment. Outcomes include the CAPs 5 for PTSD and TLFB for opioid use; other mental health outcomes are also explored.

What are the potential side effects?

While not explicitly listed here, potential side effects of MDMA can include anxiety, headache, fatigue, muscle tension or cramps, nausea or gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant and agree to use birth control during the study.

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I have been on a stable dose of methadone (180 mg or less) or buprenorphine (24 mg or less) daily for opioid use disorder for at least 3 months.

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I am 18 years old or older.

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 do not have conditions that make certain drugs harmful, including uncontrolled high blood pressure, recent heart rhythm problems, liver disease, extreme sodium levels, or being under 48 kg. I am not pregnant or am using effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks after 3rd experimental session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks after 3rd experimental session

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after 3rd experimental session for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

PTSD

Secondary study objectives

Opioid Use Disorder

Other study objectives

Effect on nonopioid substance use disorders

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: Co-occurring PTSD and OUD prior and after treatment with MDMA Assisted TherapyExperimental Treatment1 Intervention

The intervention is MDMA Assisted Therapy focused on PTSD and three experiment sessions with the first session using an initial dose of 100 mg MDMA HCL (\~80 mg MDMA) with supplemental dose of 40 mg MDMA HCL (\~35 mg MDMA). Total dose range for the first session is 100 mg MDMA HCL (\~80 mg MDMA) to 140 mg MDMA HCL (\~115 mg MDMA).The second and third sessions may use an initial dose of 120 mg MDMA HCL (\~100 mg MDMA) with a supplemental dose of 60 mg MDMA HCL (\~50 mg MDMA) for a total dose range of 120 mg MDMA HCL (\~100 mg MDMA) to 180 mg MDMA HCL (\~160 mg MDMA) Total cumulative dose range for the three sessions is 340mg MDMA HCL (\~280 mg MDMA) to 500 mg MDMA HCL (\~435 mg MDMA)

0 / 5Eligibility criteria met