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Posttraumatic Stress DisorderPhase 2NCT01958593

Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD

A Phase 2 study testing Midomafetamine HCl and Psychotherapy in people with Posttraumatic Stress Disorder, run by Resilient Pharmaceuticals at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The goal of this clinical trial is to compare full dose MDMA-assisted therapy to placebo with therapy in participants with chronic, treatment-resistant PTSD. The main question it aims to answer is: Does MDMA-assisted therapy versus placebo with therapy reduce PTSD symptoms? Participants will receive either… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Posttraumatic Stress Disorder
What is being tested?
Midomafetamine HCl and Psychotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6 participants
Where
1 siteCanada
Study dates
14 Oct 2014to 17 Oct 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with moderate to severe PTSD;
  • Have chronic PTSD, defined as persisting for longer than 6 months;
  • Have treatment-resistant PTSD, meaning unable to achieve remission despite previous therapy or medication or discontinued treatment due to inability to tolerate previous therapy or medication;
  • Are willing to refrain from taking any psychiatric medications during the study period;
  • Willing to remain overnight at the study site;
  • Agree to have transportation home after experimental sessions;
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  • Are willing to be contacted via telephone for all necessary telephone contacts;
  • Must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control;
  • Are proficient in speaking and reading English;
  • Agree not to participate in any other interventional clinical trials during the duration of this study.

Who cannot join

  • Are pregnant or nursing, or if of child bearing potential, are not practicing an effective means of birth control;
  • Weigh less than 48 kg;
  • Are unable to give adequate informed consent;
  • Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary;
  • Have used "Ecstasy" (illicit drug preparations purported to contain MDMA) more than five times in the last 10 years or at least once within six months of enrollment;
  • Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Offices of Dr. Ingrid Pacey MBBS FRCP[C]

    Vancouver, British Columbia, V6R 1N6

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Controlled Phase 2 Pilot Study of Manualized 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in 12 Subjects With Treatment-Resistant Posttraumatic Stress Disorder (PTSD) - Canada

The goal of this clinical trial is to compare full dose MDMA-assisted therapy to placebo with therapy in participants with chronic, treatment-resistant PTSD. The main question it aims to answer is: Does MDMA-assisted therapy versus placebo with therapy reduce PTSD symptoms?

Participants will receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart. During experimental sessions, participants receive an initial dose of 125 mg of MDMA HCl, or placebo, followed by a dose of 62.5 mg of MDMA HCl, or placebo. During this treatment period, participants will also undergo non-drug preparatory therapy sessions and non-drug integration sessions.

Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with therapy group to see if there is a reduction in symptoms after the treatment period. Safety measures will also be assessed between groups.

Read the detailed description

This randomized, double-blind, placebo-controlled clinical study will assess the safety and efficacy of MDMA-assisted therapy in treating chronic, treatment-resistant PTSD. In Stage 1, participants will be randomized to either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions, spaced three to five weeks apart. During experimental sessions, participants receive an initial dose of 125 mg of MDMA HCl, or placebo, followed by a dose of 62.5 mg of MDMA HCl, or placebo. During this treatment period, participants will also undergo non-drug preparatory therapy sessions and non-drug integration sessions. After this treatment period, participants will complete the primary endpoint assessment and the study will become unblinded.

Participants who were assigned to receive MDMA-assisted therapy will receive a third session of MDMA-assisted therapy that is open-label and participants assigned to receive placebo with therapy will have the option to enter Stage 2. Stage 2 will explore the optimal therapeutic dose of MDMA in a clinical titration dosing strategy. Participants will receive MDMA-assisted with an initial dose of 100 mg followed by a dose of 50 mg of MDMA HCl for the first experimental session. In the second and third experimental sessions, participants will have the option to increase the dose to an initial dose of 125 mg followed by a dose of 62.5 mg.

A blinded independent rater will assess PTSD symptoms via the CAPS-IV as well as other secondary outcome measures and safety measures.

Being tested
Placebo, Midomafetamine HCl, Psychotherapy
Keywords
PTSD, Posttraumatic stress disorder, MDMA, psychotherapy, therapy
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.

  • PlaceboDrug

    Also called Inactive placebo

    Placebo with therapy administered in two blinded experimental sessions. Participants in this group in Stage 1 may take part in Stage 2.

  • Midomafetamine HClDrug

    Also called MDMA HCl, 3,4-methylenedioxymethamphetamine, midomafetamine, MDMA

    Participants will receive MDMA-assisted therapy during two blinded experimental sessions. After unblinding, may receive a third session of open-label MDMA-assisted therapy.

  • PsychotherapyBehavioural

    Psychotherapy before and after experimental sessions.

Study groups in NCT01958593
Study groupRoleWhat they receive
Placebo with therapyPlacebo comparatorParticipants will receive placebo with therapy during each of two experimental sessions.
Receives: Drug: Placebo; Behavioral: Psychotherapy
MDMA-assisted therapyExperimentalParticipants will receive MDMA (initial dose of 125 mg midomafetamine HCl followed by a supplemental dose of 62.5 mg midomafetamine HCl) with therapy during each of two experimental sessions.
Receives: Drug: Midomafetamine HCl; Behavioral: Psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Clinician-Administered PTSD Scale (CAPS-IV) Score From Baseline to Primary Endpoint

    Clinician-administered and scored assessment of PTSD symptoms via structured interview, including global symptom severity, dichotomous diagnostic score and subscale scores. The Clinician-Administered PTSD Scale for DSM-4 (CAPS-4) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-4. It contains symptom subscales, a CAPS-4 total severity score, and a diagnostic score. 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.

    Measured: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)

Secondary outcomes (6)

  1. Change in PTSD Diagnostic Scale (PDS) Total Severity Score From Baseline to Primary Endpoint

    The PTSD Diagnostic Scale (PDS) is a 49 item self-report measure designed to follow DSM-IV criteria for assessing PTSD. The PDS consists of a checklist to identify potentially traumatizing events experienced by the respondent and respondents then indicate which of the experienced events has troubled them the most in the last month and rate their response to this event at the time of its occurrence. Respondents then rate the severity of 17 items representing the cardinal symptoms of PTSD experienced in the past 30 days on a scale from 0 ("not at all") to 3 ("5 or more times a week") as well as the level of impairment caused by their symptoms across nine areas of life functioning. The 17 symptom severity items are summed to create a total symptom severity score, which ranges from 0 to 51, with higher scores indicating greater symptom severity and/or frequency.

    Measured: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)

  2. Change in Beck Depression Inventory (BDI-II) Score From Baseline to Primary Endpoint

    The BDI-II is a validated 21-item self-report measure of symptoms of depression according to DSM-IV criteria. A BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.

    Measured: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)

  3. Change in Global Assessment of Functioning (GAF) Score From Baseline to Primary Endpoint

    The GAF Scale is a numeric scale ranging from 0 (serious risk of causing harm to the self or others) through 100 (superior function) that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. The GAF is a reliable, validated measure of social functioning (Goldman, Skodol, and Lave, 1992). Higher scores indicate better functioning.

    Measured: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)

  4. Change in Pittsburgh Sleep Quality Index (PSQI) Score From Baseline to Primary Endpoint

    The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 19 items that yield 7 component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.

    Measured: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)

  5. Change in Dissociation Experiences Scale II (DES-II) Total Score From Baseline to Primary Endpoint

    The DES-II is a 28-item self-report measure of dissociation, defined as a lack of normal integration of an individual's thoughts, feelings, or experiences into the stream of consciousness or memory. It is an established measure of dissociative symptoms. The scale consists of statements describing facets of dissociation. Respondents indicate how often the specific experience happens to them, from from "never" (0% of the time) to "always" (100%). The scale is scored by treating percentages as single digits and averaging to produce a total score, ranging from 0 to 100. The higher the score, the more dissociative symptoms.

    Measured: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)

  6. Change in Posttraumatic Growth Inventory (PTGI) Total Score From Baseline to Primary Endpoint

    The PTGI is a 21-item self-report measure of perceived growth or benefits occurring after a traumatic event. It contains 5 subscales: relationship to others, new possibilities, personal strength, spiritual change, and appreciation of life. Responses to each question are made on a scale of 0 (no change) to 5 (great degree of change), with higher scores indicating greater personal growth. Items are added to calculate the total PTGI score which ranges from 0 to 105, with higher scores indicative of greater growth.

    Measured: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2013 (estimated)
  2. Study start14 Oct 2014
  3. Primary completion10 Sep 2015
  4. Study completion17 Oct 2016

Why it stopped: This pilot study was terminated early by sponsor due to insufficient rate of accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01958593
Sponsor's protocol ID
MP-4
Status last verified
May 2025
First submitted
7 Oct 2013
Last updated
5 Jun 2025

Publications

  • Jerome L, Feduccia AA, Wang JB, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials. Psychopharmacology (Berl). 2020 Aug;237(8):2485-2497. doi: 10.1007/s00213-020-05548-2. Epub 2020 Jun 4.

    PubMed 32500209

  • Feduccia AA, Jerome L, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline. Front Psychiatry. 2019 Sep 12;10:650. doi: 10.3389/fpsyt.2019.00650. eCollection 2019.

    PubMed 31572236

  • Mithoefer MC, Feduccia AA, Jerome L, Mithoefer A, Wagner M, Walsh Z, Hamilton S, Yazar-Klosinski B, Emerson A, Doblin R. MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology (Berl). 2019 Sep;236(9):2735-2745. doi: 10.1007/s00213-019-05249-5. Epub 2019 May 7.

    PubMed 31065731

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Midomafetamine HCl and Psychotherapy in people with Posttraumatic Stress Disorder, run by Resilient Pharmaceuticals at 1 site in Canada.

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 10 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Jun 2025. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Clinician-Administered PTSD Scale (CAPS-IV) Score From Baseline to Primary Endpoint (time frame: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd 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 NCT01958593, which also lists 3 linked publications.

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 Jun 2025.

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