Posttraumatic Stress DisorderNCT02102802
Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD
An observational study of Posttraumatic Stress Disorder, run by Resilient Pharmaceuticals at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Midomafetamine and Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 3 Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants enrolled in the parent study, MP-8
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Offices of Michael Mithoefer
Mt. Pleasant, South Carolina, 29464-4345
About this study
Official title: Exploring Mechanisms of Action of ±3,4-methylenedioxymethamphetamine (MDMA)- Assisted Psychotherapy for Posttraumatic Stress Disorder (PTSD)
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.
Read the detailed description
This exploratory sub-study will identify psychotherapeutic processes occurring during MDMA- assisted psychotherapy in people with chronic PTSD and assess the feasibility of exploring physiological correlates of clinical outcomes in subjects enrolled in the ongoing clinical trial of MDMA-assisted psychotherapy, NCT #: NCT01211405. The sub-study will be conducted in collaboration with researchers at the Medical University of South Carolina (MUSC), Smith College and the New School for Social Research.
To support the clinical outcomes measured by CAPS from the MP-8 study, the sponsor is interested in correlations of outcomes with treatment-related changes in potential biological markers of PTSD, measured by heart rate variability (HRV) and fMRI. Brain activity while listening to neutral and personalized trauma-related scripts will take place at baseline and after experimental MDMA-assisted psychotherapy with low, medium, or full dose MDMA. The fMRI scan will be followed by a Diffusion Tensor Imaging (DTI) scan. After each scanning session, pulse measurements will be extracted as a digital data file from which HRV will be calculated. FMRI scans and HRV measurements will occur at baseline for participants in all conditions, one month after the second experimental session and again after a final experimental session for participants in the low or medium dose condition, and two months after the final experimental session for participants in the full dose condition.
Participants will complete the Self-Compassion Scale, a self-report measure of self-compassion at Baseline and after the final MDMA-assisted psychotherapy session. Psychotherapeutic processes will be assessed via observing psychotherapy and sorting a set of 100 therapy-related items as a means of describing the interactions. Trained coders will observe at least one pre-drug psychotherapy session, one experimental (drug-assisted psychotherapy) session and one post-drug psychotherapy session.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Midomafetamine, Therapy
- Keywords
- PTSD, MDMA, Brain activity, fMRI, Heart rate variability, Physiological correlate
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidomafetamineDrug
Also called 3,4-methylenedioxymethamphetamine, MDMA
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
TherapyBehavioural
Manualized therapy
| Study group | Role | What they receive |
|---|---|---|
| MDMA-assisted therapy | Participants undergoing MDMA-assisted therapy in the main study, MP-8 (NCT#01211405) Receives: Drug: Midomafetamine; Behavioral: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, two months after final experimental session
Secondary outcomes (5)
Change in heart rate variability in response to trauma script
Assessment of Heart rate variability (HRV) in response to trauma-related scripts; a potential physiological correlate of response to treatment for PTSD
Measured: Baseline, one month post-drug
Change in Self Compassion Scale Score
Self-report measure of self-compassion
Measured: Baseline, one month post-drug
Change in heart rate variability in response to trauma script
Assessment of Heart rate variability (HRV) in response to trauma-related scripts; a potential physiological correlate of response to treatment for PTSD
Measured: Baseline, two months post final drug administration
Change in Self Compassion Scale Score
Self-report measure of self-compassion
Measured: Baseline, two months post final drug administration
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
Measured: Baseline, one month post-drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startJan 2014
- Primary completion3 Aug 2015
- Study completion3 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael C Mithoefer, MD, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102802
- Sponsor's protocol ID
- MP8-S1
- Status last verified
- Nov 2024
- First submitted
- 27 Mar 2014
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 36713926
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Mechanisms of Action of ±3,4-methylenedioxymethamphetamine (MDMA)- Assisted Psychotherapy for Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT02102802
- Acronym / sponsor ID
- MP8-S1
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, MDMA, Brain activity, fMRI, Heart rate variability, Physiological correlate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- 3 Aug 2015 (actual)
- Study completion
- 3 Aug 2015 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This exploratory sub-study will identify psychotherapeutic processes occurring during MDMA- assisted psychotherapy in people with chronic PTSD and assess the feasibility of exploring physiological correlates of clinical outcomes in subjects enrolled in the ongoing clinical trial of MDMA-assisted psychotherapy, NCT #: NCT01211405. The sub-study will be conducted in collaboration with researchers at the Medical University of South Carolina (MUSC), Smith College and the New School for Social Research.
To support the clinical outcomes measured by CAPS from the MP-8 study, the sponsor is interested in correlations of outcomes with treatment-related changes in potential biological markers of PTSD, measured by heart rate variability (HRV) and fMRI. Brain activity while listening to neutral and personalized trauma-related scripts will take place at baseline and after experimental MDMA-assisted psychotherapy with low, medium, or full dose MDMA. The fMRI scan will be followed by a Diffusion Tensor Imaging (DTI) scan. After each scanning session, pulse measurements will be extracted as a digital data file from which HRV will be calculated. FMRI scans and HRV measurements will occur at baseline for participants in all conditions, one month after the second experimental session and again after a final experimental session for participants in the low or medium dose condition, and two months after the final experimental session for participants in the full dose condition.
Participants will complete the Self-Compassion Scale, a self-report measure of self-compassion at Baseline and after the final MDMA-assisted psychotherapy session. Psychotherapeutic processes will be assessed via observing psychotherapy and sorting a set of 100 therapy-related items as a means of describing the interactions. Trained coders will observe at least one pre-drug psychotherapy session, one experimental (drug-assisted psychotherapy) session and one post-drug psychotherapy session.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDMA-assisted therapy | – | Drug: Midomafetamine, Behavioral: TherapyParticipants undergoing MDMA-assisted therapy in the main study, MP-8 (NCT#01211405) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants enrolled in the parent study, MP-8
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidomafetamineAlso: 3,4-methylenedioxymethamphetamine, MDMA125, 75, or 30 mg midomafetamine HCl followed 1.5 to 2 hours later by a supplemental dose of midomafetamine HCl half the initial dose | Drug | MDMA-assisted therapy |
| TherapyManualized therapy | Behavioural | MDMA-assisted therapy |
Primary outcome
Change in brain activity measured via fMRI while listening to trauma scripts
Time frame: Baseline, two months after final experimental session
Brain activity measured via functional magnetic resonance imaging (fMRI) after listening to trauma-related scripts.
5 secondary outcomes
Change in heart rate variability in response to trauma script
Time frame: Baseline, one month post-drug
Change in Self Compassion Scale Score
Time frame: Baseline, one month post-drug
Change in heart rate variability in response to trauma script
Time frame: Baseline, two months post final drug administration
Change in Self Compassion Scale Score
Time frame: Baseline, two months post final drug administration
Change in brain activity measured via fMRI while listening to trauma scripts
Time frame: Baseline, one month post-drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Derived from this study: PubMed 36713926Singleton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Mithoefer, MD principal investigator
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Stress Disorder, run by Resilient Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain activity measured via fMRI while listening to trauma scripts (time frame: Baseline, two months after final experimental session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02102802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.