Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans

PTSD Clinical Trial

— MPG1  

Official title:

An Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05173831
• Other study ID #: MPG1
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Lykos Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Phase 2, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans. The study will be conducted in up to N=18 participants, recruited in three cohorts of six participants and receive therapy sessions throughout their participation in these groups.

Description:

To further assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor is conducting a phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA, along with non-drug preparatory and integrative therapy administered in both individual and group sessions. The Primary Outcome measure, the Clinician Administered PTSD Scale (CAPS-5), evaluates changes in PTSD symptom severity and is assessed by a blinded centralized Independent Rater (IR) pool. The therapeutic approach will combine manualized MDMA-assisted therapy for PTSD with group therapy components.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Are at least 18 years old.

• Are a U.S. Military Veteran

• Are fluent in speaking and reading the predominantly used or recognized language of the study site.

• Are able to swallow pills.

• Agree to have study visits recorded, including Experimental Sessions, outcome assessments, and non-drug psychotherapy sessions.

• Must provide a contact 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 able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraception through 10 days after the last Experimental Session.

• Must not participate in any other interventional clinical trials during the duration of the study.

• Must commit to medication dosing, therapy, and study procedures.

• Have a current PTSD diagnosis at the time of screening.

Exclusion Criteria:

• Are not able to give adequate informed consent.

• Have uncontrolled hypertension.

• Have a marked baseline QTcF interval >450 milliseconds [ms] demonstrated on repeated ECG assessments.

• 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 or biliary disease.

• Have history of hyponatremia or hyperthermia.

• Weigh less than 48 kilograms (kg).

• Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.

• Are abusing illegal drugs or alcohol.

Related Conditions & MeSH terms

• PTSD

Intervention

Drug:
• Midomafetamine
Initial dose of 120 mg MDMA HCL and optional supplemental dose of 60 mg MDMA HCL at 1.5 to 2 hours after first dose

Behavioral:
• Therapy
Standardized non-directive psychotherapy performed by therapist team

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lykos Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CAPS-5 Total Severity Score	The CAPS-5 is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure [114], including the most distressing event, time since exposure, to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score [114]. The CAPS-5 rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.	Baseline - 3 months from first Experimental Session
Secondary	Change in Sheehan Disability Scale (SDS)	Sheehan Disability Scale (SDS) total score, a measure of clinician-rated functional impairment. The first three items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), and five verbal tags (not at all, mildly, moderately, markedly, extremely). The remaining two items assess Days Lost and Days Unproductive during the reporting period.	Baseline - 3 months from First Experimental Session