NCT02102802

Brief Summary

The goal of this observational sub-study is to provide information on how MDMA-assisted therapy affects the brain and body of people with chronic PTSD. The main question it aims to answer is: Is PTSD symptom reduction associated with changes in heart rate variability and brain activity? Participants from the MP-8 study will be invited to enroll in this sub-study where they will undergo an fMRI brain scan and other measurements of body function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2015

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

1.6 years

First QC Date

March 27, 2014

Last Update Submit

November 1, 2024

Conditions

Posttraumatic Stress Disorder

Keywords

PTSDMDMABrain activityfMRIHeart rate variabilityPhysiological correlate

Outcome Measures

Primary Outcomes (1)

  • Change in brain activity measured via fMRI while listening to trauma scripts

    Brain activity measured via functional magnetic resonance imaging (fMRI) after listening to trauma-related scripts.

    Baseline, two months after final experimental session

Secondary Outcomes (5)

  • Change in heart rate variability in response to trauma script

    Baseline, one month post-drug

  • Change in Self Compassion Scale Score

    Baseline, one month post-drug

  • Change in heart rate variability in response to trauma script

    Baseline, two months post final drug administration

  • Change in Self Compassion Scale Score

    Baseline, two months post final drug administration

  • Change in brain activity measured via fMRI while listening to trauma scripts

    Baseline, one month post-drug

Other Outcomes (3)

  • Psychotherapy Process Q-set (PSQ)

    3 - 7 weeks post enrollment

  • Psychotherapy Process Q-set (PSQ)

    8 - 16 weeks post-enrollment

  • Psychotherapy Process Q-set (PSQ)

    17-27 weeks post-enrollment

Study Arms (1)

MDMA-assisted therapy

Participants undergoing MDMA-assisted therapy in the main study, MP-8 (NCT#01211405)

Drug: MidomafetamineBehavioral: Therapy

Interventions

MidomafetamineDRUG

125, 75, or 30 mg midomafetamine HCl followed 1.5 to 2 hours later by a supplemental dose of midomafetamine HCl half the initial dose

Also known as: 3,4-methylenedioxymethamphetamine, MDMA
MDMA-assisted therapy
TherapyBEHAVIORAL

Manualized therapy

MDMA-assisted therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants enrolled in the parent study, MP-8

You may qualify if:

  • Enrolled in the parent study, "A Randomized, Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 24 Veterans, Firefighters, and Police Officers with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)." NCT #: NCT01211405

You may not qualify if:

  • Mass brain lesion
  • Have metal in their skulls,
  • Having brain or heart pacemakers
  • History of major head trauma
  • Have past or present panic or extreme discomfort with being in small enclosed spaces (claustrophobia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Offices of Michael Mithoefer

Mt. Pleasant, South Carolina, 29464-4345, United States

Location

Related Publications (1)

  • Singleton SP, Wang JB, Mithoefer M, Hanlon C, George MS, Mithoefer A, Mithoefer O, Coker AR, Yazar-Klosinski B, Emerson A, Doblin R, Kuceyeski A. Altered brain activity and functional connectivity after MDMA-assisted therapy for post-traumatic stress disorder. Front Psychiatry. 2023 Jan 12;13:947622. doi: 10.3389/fpsyt.2022.947622. eCollection 2022.

    PMID: 36713926DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

N-Methyl-3,4-methylenedioxyamphetamineTherapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Michael C Mithoefer, MD

    Private Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 3, 2014

Study Start

January 1, 2014

Primary Completion

August 3, 2015

Study Completion

August 3, 2015

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations

US(1)