ClinicalTrials.Veeva

Menu

MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder

S

Stephen Robert Marder

Status and phase

Not yet enrolling
Phase 2

Conditions

Post Traumatic Stress Disorder

Treatments

Drug: d-amphetamine
Drug: 3,4-methylenedioxymethamphetamine
Behavioral: Therapy

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

Details and patient eligibility

About

This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.

Full description

This randomized, double-blind, single-site phase II 2-arm study will compare MDMA-assisted therapy with low dose d-amphetamine-assisted therapy to treat PTSD symptoms in veteran participants aged 18 years and older with PTSD of at least moderate severity, as measured by the change in CAPS-5 total severity score. The study will be conducted in up to N=40 participants from the Greater Los Angeles VA randomized with a 1:1 allocation to Group 1: MDMA-assisted therapy or Group 2: low dose d-amphetamine assisted therapy.

For each participant, the study will consist of:

  • Screening Period: phone screen, informed consent, eligibility assessment, Screening CAPS-5, and Initial Enrollment of eligible participants.
  • Preparatory Period: medication tapering, three Preparatory Sessions, baseline assessments (including Baseline CAPS-5), leading to Enrollment Confirmation.
  • Treatment Period: three Experimental Sessions, and three Integrative Sessions following each Experimental Session including CAPS-5 assessments.
  • Follow-up Period and Study Termination: Primary Outcome CAPS-5 assessment and Study Termination visit.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months.
  • Fluent in speaking and reading the predominantly used or recognized language of the study site (English).
  • Must be a veteran enrolled at a VA Healthcare Center in the Greater Los Angeles area.
  • Able to swallow pills.
  • Agree to have study visits audiovisually recorded, including Experimental Sessions, IR assessments, and non-drug therapy sessions.
  • Able to 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 the participant becoming unwell or unreachable.
  • Able to identify appropriate support person(s) to stay with the participant on the evenings of Experimental Sessions if needed.
  • May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease.
  • May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
  • Body weight of at least 45 kilograms (kg). Participants with a body weight of 45-48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg/m2. BMI must be within 18 to 32 kg/m2 (inclusive).
  • A person able to be pregnant (PABP) must use a highly effective contraceptive method.

Exclusion criteria

  • Are not able to give adequate informed consent.
  • Have evidence or history of significant medical or psychiatric disorders.
  • Are abusing illegal drugs.
  • Unable or unwilling to safely taper off prohibited psychiatric medication.
  • Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

MDMA-Assisted Therapy
Experimental group
Description:
Participants will receive a flexible divided-dose of MDMA plus therapy at Experimental Sessions.
Treatment:
Behavioral: Therapy
Drug: 3,4-methylenedioxymethamphetamine
Low Dose D-Amphetamine Assisted Therapy
Active Comparator group
Description:
Participants will receive a flexible divided dose plus therapy at Experimental Sessions.
Treatment:
Drug: d-amphetamine
Behavioral: Therapy

Trial contacts and locations

1

Loading...

Central trial contact

Stephen Marder, MD; Stephanie L Taylor, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems