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Psychedelic

Co-occurring PTSD and OUD prior and after treatment with MDMA Assisted Therapy for 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks after 3rd experimental session

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PTSD

Secondary outcome measures

Opioid Use Disorder

Other outcome measures

Effect on nonopioid substance use disorders

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 / 3Eligibility criteria met

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Who is running the clinical trial?

Lykos TherapeuticsOTHER

41 Previous Clinical Trials

1,624 Total Patients Enrolled

University of New MexicoLead Sponsor

373 Previous Clinical Trials

3,528,836 Total Patients Enrolled

Multidisciplinary Association for Psychedelic StudiesOTHER

39 Previous Clinical Trials

1,598 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA endorsed the utilization of MDMA-assisted therapy for managing concurrent PTSD and OUD, both pre- and post-treatment?

"The safety evaluation of treating Co-occurring PTSD and OUD with MDMA Assisted Therapy before and after intervention is rated at 2 by our team, indicating a moderate level of assurance. This Phase 2 trial lacks evidence supporting effectiveness but does provide some data on safety aspects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MDMA for Co-occurring PTSD and OUD After Childbirth

2024. "MDMA for Co-occurring PTSD and OUD After Childbirth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05219175.

All > Post Traumatic Stress Disorder > Ptsd