Study of Safety and Effects of MDMA-assisted Therapy for... | NCT04968938

Studies
Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD

NCT04968938

Sponsor

Resilient Pharmaceuticals

Status

Withdrawn

Last Update Posted

Nov 1, 2024Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Posttraumatic Stress Disorder

Interventions

midomafetamine
Therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decided not to pursue the study. Study ended prior to study start.

Expanded Access Info

Start Date

Aug 2022Estimated

Primary Completion Date

Aug 2023Estimated

Completion Date

Aug 2023Estimated

First Submitted Date

Jul 9, 2021

First Submission Date that Met QC Criteria

Jul 9, 2021

First Posted Date

Jul 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2024

Last Update Posted Date

Nov 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with PTSD.

The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms?

Participants will undergo three non-drug preparatory therapy sessions followed by two open-label MDMA-assisted therapy sessions. After, participants will undergo three non-drug integrative therapy sessions.

Detailed Description

This Phase 2, open-label study will provide supportive data on the safety and effectiveness of MDMA-assisted therapy in participants with PTSD. This study will be conducted at a single study site in Vancouver, BC. There will be at least 2 co-therapy pairs. The study will enroll up to 20 participants.

The Preparatory Period will consist of three 90-minute non-drug preparatory therapy sessions. A flexible divided dose of MDMA will be administered during the Treatment Period with manualized therapy in up to two open-label experimental sessions. During the Treatment Period, each experimental session is followed by three 90-minute non-drug integrative therapy sessions. The experimental sessions are scheduled roughly 3 to 5 weeks apart.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MDMA-assisted therapy	Experimental	Two sessions of MDMA-assisted therapy with an initial dose of 80 mg or 120 mg midomafetamine HCl and optional supplemental dose of 40 mg 1.5 to 2 hours later	Drug: midomafetamine Behavioral: Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
midomafetamine	Drug	80 mg or 120 mg midomafetamine HCl followed by a 40 mg supplement dose	MDMA-assisted therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in PTSD Checklist (adapted PCL-5) total score	20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the symptoms of PTSD per DSM-5. The gold standard for diagnosing PTSD is a structured clinical interview such as the Clinician-Administered PTSD Scale (CAPS-5). When necessary, the PCL-5 can be scored to provide a provisional PTSD diagnosis.The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."	18 weeks post baseline post enrollment confirmation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are at least 18 years old.
Are fluent in speaking and reading a recognized language of the study site.
Are able to swallow pills.
Agree to have study visits recorded, including Study Drug Sessions and non-drug therapy sessions.
Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
Must not participate in any other interventional clinical trials during the duration of the study, and commit to medication dosing, therapy, and study procedures.
At baseline, have moderate PTSD diagnosis.

Exclusion Criteria:

Are not able to give adequate informed consent.
Have uncontrolled hypertension.
Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] in males and>460 ms in females corrected by Friderica's formula).
Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
Have evidence or history of significant medical disorders.
Have symptomatic liver disease.
Have history of hyponatremia or hyperthermia.
Weigh less than 48 kilograms (kg).
Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
Have current alcohol or substance use disorders.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Devon Christie, MD	Department of Medicine, University of British Columbia	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

We will share outcome data appearing in any published reports upon request.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Data and study-related documents will be available when the database has been locked and data has been unblinded.

Access Criteria

Interested persons should correspond with the central contact for the multisite study.

URL

Not provided

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

ID	Term
D018817	N-Methyl-3,4-methylenedioxyamphetamine
D013812	Therapeutics

ID	Term
D000662	Amphetamines
D010627	Phenethylamines
D005021	Ethylamines
D000588	Amines
D009930