Psychological Effects of Study DrugPhase 1NCT04073433
Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2)
A Phase 1 study testing Midomafetamine HCl and Therapy in people with Psychological Effects of Study Drug, run by Resilient Pharmaceuticals.
Trial summary
The goal of this clinical trial is to study MDMA-assisted therapy in healthy volunteers and provide training of therapists. The main question it aims to answer is: Does MDMA-assisted therapy result in personal and professional benefits? Participants will have a non-drug preparatory session prior to each experimental… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Effects of Study Drug
- What is being tested?
- Midomafetamine HCl and Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2025
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are learning to conduct MDMA-assisted psychotherapy or MDMA research through the MDMA Therapy Training Program
- Are at least 18 years old
- Are fluent in speaking and reading the predominantly used or recognized language of the study site
- Are able to swallow pills
- Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigator in the event of an emergency or if the participant is unreachable
- Must agree to inform the investigators within 48 hours if any medical conditions occur or medical procedures are planned
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- If of childbearing potential, must have a negative pregnancy test at study entry and prior to the Experimental Session, and must agree to use adequate birth control through 10 days after the Experimental Session
- If nursing, must be willing to dispose of breastmilk from dosing through 5 days after each Experimental Session
- Must not participate in any other interventional clinical trials during the duration of the study
- Must agree to not operate a vehicle for at least 24 hours after initial drug administration.
- Must have transportation available after the Experimental Session and through the following day, for traveling back for the Integrative Session.
- Must commit to medication dosing, therapy, and study procedures
- Are willing to be contacted via telephone for all necessary telephone contacts.
Who cannot join
- Are not able to give adequate informed consent
- Have uncontrolled hypertension
- Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] in males and >460 ms in females corrected by Bazett's formula)
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Have evidence or history of significant medical disorders
- Have symptomatic liver disease
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- Have history of hyponatremia or hyperthermia
- Weigh less than 45 kilograms (kg)
- Are pregnant, or are of childbearing potential and are not practicing an effective means of birth control
- Have any current problematic patterns of alcohol or other substance use
About this study
Official title: A Phase 1, Open-Label, Multi-Site Study to Assess Psychological Effects of MDMA-Assisted Psychotherapy When Administered to Healthy Volunteers
The goal of this clinical trial is to study MDMA-assisted therapy in healthy volunteers and provide training of therapists. The main question it aims to answer is:
Does MDMA-assisted therapy result in personal and professional benefits?
Participants will have a non-drug preparatory session prior to each experimental session and an integrative session after each experimental session.
Read the detailed description
The Phase 1, randomized, placebo-controlled study MT1 was designed to collect safety and quantitative data on mood, psychological symptoms, personality traits, and interpersonal closeness in therapists learning to conduct MDMA-assisted psychotherapy or MDMA research among 120 healthy volunteers. The MT1 study was also designed to expand the knowledge of therapists training to conduct MDMA-assisted psychotherapy research. In the MT1 study, several participants submitted optional written narratives with impressions that participating in MDMA-assisted psychotherapy helped them professionally and personally.
This Phase 1, open-label, multi-site research study is designed to build upon the MT1 study to further assess the psychological effects and safety of manualized MDMA-assisted psychotherapy, while supporting the expansion of knowledge for treatment providers who are learning to conduct MDMA-assisted psychotherapy or MDMA research. This study is intended to look further into the personal and professional benefits spontaneously reported in narratives to the site team from the MT1 study participants. This will be done by collecting changes in self-compassion, burnout, professional quality of life, psychological inflexibility, and mood using validated measures in a larger sample of treatment providers, allowing for effect size calculations.
- Conditions
- Psychological Effects of Study Drug
- Being tested
- Midomafetamine HCl, Therapy
- Keywords
- Mood, Subjective Effects, MDMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midomafetamine HClDrug
Also called 3,4-methylenedioxymethamphetamine, MDMA, midomafetamine, MDMA HCl
120 mg midomafetamine HCl
TherapyBehavioural
Non-directive therapy conducted during MDMA-assisted therapy session
| Study group | Role | What they receive |
|---|---|---|
| MDMA-assisted therapy | Experimental | One session of MDMA-assisted therapy with a dose of 120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later Receives: Drug: Midomafetamine HCl; Behavioral: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Self Compassion Scale (SCS) total score
Self Compassion Scale (SCS) total score, a 26-item self-report measure of self-compassion
Measured: 9 weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Effects of Study DrugStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcela Ot'alora, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073433
- Sponsor's protocol ID
- MT2
- Status last verified
- Oct 2024
- First submitted
- 30 Jul 2019
- Last updated
- 31 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multi-Site Study to Assess Psychological Effects of MDMA-Assisted Psychotherapy When Administered to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04073433
- Acronym / sponsor ID
- MT2
- Conditions
- Psychological Effects of Study Drug
- Keywords
- Mood, Subjective Effects, MDMA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Aug 2019 (actual)
- 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 clinical trial is to study MDMA-assisted therapy in healthy volunteers and provide training of therapists. The main question it aims to answer is:
Does MDMA-assisted therapy result in personal and professional benefits?
Participants will have a non-drug preparatory session prior to each experimental session and an integrative session after each experimental session.
Detailed description
The Phase 1, randomized, placebo-controlled study MT1 was designed to collect safety and quantitative data on mood, psychological symptoms, personality traits, and interpersonal closeness in therapists learning to conduct MDMA-assisted psychotherapy or MDMA research among 120 healthy volunteers. The MT1 study was also designed to expand the knowledge of therapists training to conduct MDMA-assisted psychotherapy research. In the MT1 study, several participants submitted optional written narratives with impressions that participating in MDMA-assisted psychotherapy helped them professionally and personally.
This Phase 1, open-label, multi-site research study is designed to build upon the MT1 study to further assess the psychological effects and safety of manualized MDMA-assisted psychotherapy, while supporting the expansion of knowledge for treatment providers who are learning to conduct MDMA-assisted psychotherapy or MDMA research. This study is intended to look further into the personal and professional benefits spontaneously reported in narratives to the site team from the MT1 study participants. This will be done by collecting changes in self-compassion, burnout, professional quality of life, psychological inflexibility, and mood using validated measures in a larger sample of treatment providers, allowing for effect size calculations.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDMA-assisted therapy | Experimental | Drug: Midomafetamine HCl, Behavioral: TherapyOne session of MDMA-assisted therapy with a dose of 120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Are learning to conduct MDMA-assisted psychotherapy or MDMA research through the MDMA Therapy Training Program
- Are at least 18 years old
- Are fluent in speaking and reading the predominantly used or recognized language of the study site
- Are able to swallow pills
- Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigator in the event of an emergency or if the participant is unreachable
Key exclusion criteria (10 listed)
- Are not able to give adequate informed consent
- Have uncontrolled hypertension
- Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] in males and >460 ms in females corrected by Bazett's formula)
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Have evidence or history of significant medical disorders
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 |
|---|---|---|
| Midomafetamine HClAlso: 3,4-methylenedioxymethamphetamine, MDMA, midomafetamine, MDMA HCl120 mg midomafetamine HCl | Drug | MDMA-assisted therapy |
| TherapyNon-directive therapy conducted during MDMA-assisted therapy session | Behavioural | MDMA-assisted therapy |
Primary outcome
Change from Baseline in Self Compassion Scale (SCS) total score
Time frame: 9 weeks post-enrollment
Self Compassion Scale (SCS) total score, a 26-item self-report measure of self-compassion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
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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.
Marcela Ot'alora principal investigator
Private Practice
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midomafetamine HCl and Therapy in people with Psychological Effects of Study Drug, run by Resilient Pharmaceuticals.
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 13 inclusion and 10 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: withdrawn, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 from Baseline in Self Compassion Scale (SCS) total score (time frame: 9 weeks post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2024.