Trial · NCT06117306
MDMA-assisted Massed Prolonged Exposure for PTSD
NCT06117306, Phase 3, Active not recruiting, Healing Breakthrough
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MDMA-assisted Massed Prolonged Exposure for PTSD. Trials, record NCT06117306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06117306
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MDMA-assisted Massed Prolonged Exposure for PTSD
- NCT number
- NCT06117306
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Healing Breakthrough
- Conditions
- Post-Traumatic Stress Disorder
- Interventions
- 3,4 Methylenedioxymethamphetamine, Prolonged Exposure
- First posted
- 2023-11-07
- Last updated
- 2026-08-26
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinician-rated PTSD symptoms | Baseline - 4-months post-treatment | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 20-item diagnostic interview administered by trained evaluators to assess PTSD in a participant. Based on DSM-5 diagnostic criteria, evaluators ask about the severity of four PTSD-related symptom clusters: re-experiencing, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. The evaluator rates responses on a 5-point Likert scale (0 = Absent to 4 = Extreme/Incapacitating). Total scores range from 0 to 80 with higher scores indicating greater severity. |
| Secondary | Self-reported PTSD symptoms | Baseline - 4-months post-treatment | The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms. Participants indicate how much distress they have experienced due to symptoms on a five-point Likert-type scale (1=Not at all to 5=Extremely). Total scores range from 0 to 80, with higher scores indicating more severe PTSD symptoms. |
| Secondary | Depressive Symptoms | Baseline - 4-months post-treatment | The Patient Health Questionnaire 9 (PHQ-9) is a 9-item self-report measure of depressive symptoms. The PHQ-9 screens for major depression, with a score of 10 or above indicative of a possible major depressive episode, and it provides a measure of severity of these symptoms. |
| Secondary | Functioning | Baseline - 4-months post-treatment | The Brief Inventory of Psychosocial Functioning (B-IPF) is a brief version of the Inventory of Psychosocial Functioning (IPF) that measures functioning impairment across seven domains: intimate relationships, family and parenting, friendships, work, socializing, education, and self-care over the past 30 days. Total scores, ranging from 0 to 100, are calculated as the sum score divided by the total possible score multiplied by 100, with higher scores indicating greater impairment in functioning. |
| Secondary | Sleep | Baseline - 4-months post-treatment | The Pittsburgh Sleep Quality Index (PSQI) measures sleep quality over the past 1-month using 19 items in a self-report questionnaire format. The scale has seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Items are rated on a combination of Likert scales from 0 to 3 and open- ended questions that are later converted to scaled scores. Higher total scores indicate greater sleep disturbance. |
| Secondary | Safety/Suicidality | Baseline - 4-months post-treatment | The C-SSRS is a clinician-administered measure of suicidal behavior devised to detect potential suicidal thoughts or behaviors during a clinical trial. It consists of a Baseline version and a Since Last Visit version that assess suicidal ideation, ideation intensity, and behavior. |
| Secondary | Sexual Functioning | Baseline - 4-months post-treatment | The CSFQ-14 is a 14-item self-report scale that evaluates sexual functioning. The measure has five subscales: pleasure, desire/frequency, desire/interest, arousal/excitement, and orgasm/completion. All items are scored on 5-point scales with varying response options. Higher total scores indicate better sexual functioning. The CSFQ-14 has corresponding assigned-male-at-birth and assigned-female-at-birth versions. |
| Secondary | Moral Injury | Baseline - 4-months post-treatment | The MIDS is a two-part self-report measure that examines potentially morally injurious events (PMIEs) exposure and moral injury symptoms in the past month. The first part of the scale uses 6 items to measure exposure to and bothersomeness of PMIEs through a 5-point Likert scale (0=Not at all to 4=Extremely). The second part of the scale includes a series of open-ended questions to select and describe the most distressing PMIE. Respondents then complete 18 items that are scored on 5-point Likert scales to indicate their cognitive, emotional, behavioral, social, and religious or spiritual reactions to the PMIE that they find the most distressing. Higher summed score indicates more severe moral distress. |
| Secondary | Adverse Childhood Experiences | Baseline | Measured using the Adverse Childhood Events Scale (ACES). The ACES is a 10-item self-report survey that asks about childhood stress. Participants indicate exposure to different kinds of abuse with yes/no responses, and answer "1" if the abuse happened often. Higher scores indicate greater exposure to childhood stressors. |
| Secondary | Posttraumatic Growth | Baseline - 4-months post-treatment | Measured using the Posttraumatic Growth Inventory (PTGI). The PTGI is a 21-item self-report measure that asks about level of posttraumatic growth across 5 subscales in adults who have experienced trauma. Participants respond using a 6-point Likert scale (1=I did not experience this change as a result of my crisis, to 6=I experienced this change to a very great degree as a result of my crisis).Total scores range from 1-126. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42999641 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06117306
GET https://conductscience.org/api/trials/v1/NCT06117306/registered