Psychological Effects of Study DrugPhase 1MT-1NCT01404754
Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers
A Phase 1 study testing midomafetamine HCl in people with Psychological Effects of Study Drug, run by Resilient Pharmaceuticals at 3 sites in United States.
Trial summary
The goal of this clinical trial is to study MDMA-assisted therapy in healthy volunteers. The main question it aims to answer is: Do two sessions of MDMA-assisted therapy result in changes in mood, emotional closeness to self and others, and other psychological symptoms? Researchers will compare MDMA-assisted therapy… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Effects of Study Drug
- What is being tested?
- midomafetamine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Apr 2011to 5 Aug 2022
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Engaged in a sponsor-supported program for training therapists to perform MDMA-assisted psychotherapy research
- Are at least 21 years old
- Are willing to follow all rules and restrictions related to study participation, including restrictions on medication use for a week prior to experimental sessions and restrictions on food and alcohol consumption on the day prior to each experimental session
- Are willing to remain overnight at the study site
- Agree to have transportation other than driving themselves after the integrative session on the day after each experimental session
- Are willing to be contacted via telephone for all necessary telephone contacts
Show all 9Show fewer
- If a woman of childbearing potential, must have a negative pregnancy test and agree to use an effective form of birth control
- Are proficient in speaking and reading English
- Agree to have all clinic visit sessions recorded to audio and video
Who cannot join
- Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control
- Weigh less than 48 kg
- Have used "ecstasy" (material represented as containing MDMA) within 6 months of the MDMA session
- Require ongoing therapy with a psychotropic drug
- Meet DSM-V criteria for substance abuse or dependence for any substance
- 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
- 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
3 sites in 1 country.
United States3 sites
Aguazul Bluewater, Inc.
Boulder, Colorado, 80304
Zen Therapeutic Solutions
Mt. Pleasant, South Carolina, 29464
Santa Fe MDMA Therapy Training, LLC
Santa Fe, New Mexico, 87508
About this study
Official title: A Phase 1 Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA When Administered to Healthy Volunteers
The goal of this clinical trial is to study MDMA-assisted therapy in healthy volunteers. The main question it aims to answer is:
Do two sessions of MDMA-assisted therapy result in changes in mood, emotional closeness to self and others, and other psychological symptoms?
Researchers will compare MDMA-assisted therapy to placebo with therapy.
Participants will have a non-drug preparatory session prior to each experimental session and an integrative session after each experimental session. Participants who received MDMA will crossover to receive placebo and placebo participants will crossover to receive MDMA.
Read the detailed description
This study is a Phase 1 study for up to a hundred people, The information gathered during this study may help us better understand the psychological effects produced by MDMA and how those effects can more effectively be used within a therapeutic context, as with people with PTSD. Participants will be healthy volunteers who have completed a program training them in conducting MDMA-assisted psychotherapy. In this randomized, double blind study, subjects will receive placebo and MDMA during two sessions scheduled at least two days apart in a psychotherapy setting. Mood, self-reported interpersonal closeness, psychological symptoms, blood pressure, heart rate and body temperature will be measured, and personality will be measured prior to the first therapy-like session and two months after the second session.
The study will follow a cross-over design, meaning that all participants will receive both MDMA and placebo, with order of session randomly assigned. Study participants will have a preparatory session prior to each experimental session and an integrative session after each session. The researchers will contact them via telephone one and two months after the second experimental session. By comparing changes in mood, feelings of emotional closeness to the self and others and psychological symptoms after placebo and after MDMA, the investigators hope to learn something about the effects of MDMA on mood, subjective experience and the way we think and feel about others.
- Conditions
- Psychological Effects of Study Drug
- Being tested
- Lactose (inactive placebo), midomafetamine HCl
- Keywords
- MDMA, mood, subjective effects, interpersonal closeness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactose (inactive placebo)Drug
Also called placebo
Placebo in an equivalent weight to midomafetamine HCl will be administered in identical appearing capsules during one of two experimental sessions. An equivalent to the initial and supplemental dose will exist.
midomafetamine HClDrug
Also called midomafetamine, MDMA, 3,4-methylenedioxymethamphetamine, MDMA HCl
120 mg midomafetamine HCl will be administered in opaque capsules at the outside of one of two experimental sessions, and upon mutual agreement between the investigator and participant, 40 mg may be administered 1.5 to 2.5 hours later.
| Study group | Role | What they receive |
|---|---|---|
| Lactose (Inactive Placebo) | Placebo comparator | Participant receives inactive placebo during day-long experimental session. Receives: Drug: Lactose (inactive placebo) |
| 3,4-methylenedioxymethamphetamine | Active comparator | Participant receives 120 mg midomafetamine HCl possibly followed by 40 mg midomafetamine HCl during a day-long experimental session. Receives: Drug: midomafetamine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Mood States (POMS)
Assesses current mood state
Measured: Experimental session approximately six hours after drug administration
Profile of Mood States (POMS)
Assesses current mood state
Measured: Day prior to each experimental session
Profile of Mood States (POMS)
Assesses current mood state
Measured: Day after each experimental session
Secondary outcomes (19)
Interpersonal closeness measure
Visual analog scale assessing emotional closeness to self and four other targets
Measured: Day prior to experimental session
Interpersonal closeness measure
Visual analog scale assessing emotional closeness to self and four other targets
Measured: Day of experimental session approximately six hours post-drug administration
Interpersonal closeness measure
Visual analog scale assessing emotional closeness to self and four other targets
Measured: Day after each experimental session
Brief Symptom Inventory (BSI)
Self-report measure assessing psychiatric symptoms
Measured: Day prior to each experimental session
Brief Symptom Inventory (BSI)
Self-report measure assessing psychiatric symptoms
Measured: Day of experimental session prior to drug administration
Brief Symptom Inventory (BSI)
Self-report measure assessing psychiatric symptoms
Measured: Day of experimental session approximately five to six hours after drug administration
Brief Symptom Inventory (BSI)
Self-report measure assessing psychiatric symptoms
Measured: Day after each experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Clinician-administered measure of suicide risk
Measured: Day prior to each experimental session
Neuroticism Extroversion Openness Personality Inventory
Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness
Measured: At baseline
Neuroticism Extroversion Openness Personality Inventory
Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness
Measured: Two months after the second experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Clinician-administered measure of suicide risk
Measured: Day after each experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Clinician-administered measure of suicide risk
Measured: One month after the second experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Clinician-administered measure of suicide risk
Measured: Two months after the second experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Clinician-administered measure of suicide risk
Measured: Day six and 12 of telephone contact after second experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Clinician-administered measure of suicide risk
Measured: Day of each experimental session prior to drug administration
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Clinician-administered measure of suicide risk
Measured: Day of each experimental session approximately five to six hours after drug administration
Blood pressure (SBP/DBP)
Periodic assessment of participant blood pressure during both experimental sessions.
Measured: Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours
Heart rate (pulse)
Periodic assessment of participant pulse during both experimental sessions.
Measured: Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours
Body temperature
Periodic assessment of participant body temperature during both experimental sessions.
Measured: Approximately every 60 minutes for each experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study start9 Apr 2011
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael M Mithoefer, MD, Study director, Resilient Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404754
- Sponsor's protocol ID
- MT-1
- Acronym
- MT-1
- Status last verified
- Oct 2024
- First submitted
- 19 Jul 2011
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA When Administered to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01404754
- Acronym / sponsor ID
- MT-1 / MT-1
- Conditions
- Psychological Effects of Study Drug
- Keywords
- MDMA, mood, subjective effects, interpersonal closeness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2011 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 28 Jul 2011 (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 clinical trial is to study MDMA-assisted therapy in healthy volunteers. The main question it aims to answer is:
Do two sessions of MDMA-assisted therapy result in changes in mood, emotional closeness to self and others, and other psychological symptoms?
Researchers will compare MDMA-assisted therapy to placebo with therapy.
Participants will have a non-drug preparatory session prior to each experimental session and an integrative session after each experimental session. Participants who received MDMA will crossover to receive placebo and placebo participants will crossover to receive MDMA.
Detailed description
This study is a Phase 1 study for up to a hundred people, The information gathered during this study may help us better understand the psychological effects produced by MDMA and how those effects can more effectively be used within a therapeutic context, as with people with PTSD. Participants will be healthy volunteers who have completed a program training them in conducting MDMA-assisted psychotherapy. In this randomized, double blind study, subjects will receive placebo and MDMA during two sessions scheduled at least two days apart in a psychotherapy setting. Mood, self-reported interpersonal closeness, psychological symptoms, blood pressure, heart rate and body temperature will be measured, and personality will be measured prior to the first therapy-like session and two months after the second session.
The study will follow a cross-over design, meaning that all participants will receive both MDMA and placebo, with order of session randomly assigned. Study participants will have a preparatory session prior to each experimental session and an integrative session after each session. The researchers will contact them via telephone one and two months after the second experimental session. By comparing changes in mood, feelings of emotional closeness to the self and others and psychological symptoms after placebo and after MDMA, the investigators hope to learn something about the effects of MDMA on mood, subjective experience and the way we think and feel about others.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactose (Inactive Placebo) | Placebo comparator | Drug: Lactose (inactive placebo)Participant receives inactive placebo during day-long experimental session. |
| 3,4-methylenedioxymethamphetamine | Active comparator | Drug: midomafetamine HClParticipant receives 120 mg midomafetamine HCl possibly followed by 40 mg midomafetamine HCl during a day-long experimental session. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Engaged in a sponsor-supported program for training therapists to perform MDMA-assisted psychotherapy research
- Are at least 21 years old
- Are willing to follow all rules and restrictions related to study participation, including restrictions on medication use for a week prior to experimental sessions and restrictions on food and alcohol consumption on the day prior to each experimental session
- Are willing to remain overnight at the study site
- Agree to have transportation other than driving themselves after the integrative session on the day after each experimental session
Key exclusion criteria (8 listed)
- Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control
- Weigh less than 48 kg
- Have used "ecstasy" (material represented as containing MDMA) within 6 months of the MDMA session
- Require ongoing therapy with a psychotropic drug
- Meet DSM-V criteria for substance abuse or dependence for any substance
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 |
|---|---|---|
| Lactose (inactive placebo)Also: placeboPlacebo in an equivalent weight to midomafetamine HCl will be administered in identical appearing capsules during one of two experimental sessions. An equivalent to the initial and supplemental dose will exist. | Drug | Lactose (Inactive Placebo) |
| midomafetamine HClAlso: midomafetamine, MDMA, 3,4-methylenedioxymethamphetamine, MDMA HCl120 mg midomafetamine HCl will be administered in opaque capsules at the outside of one of two experimental sessions, and upon mutual agreement between the investigator and participant, 40 mg may be administered 1.5 to 2.5 hours later. | Drug | 3,4-methylenedioxymethamphetamine |
Primary outcome
Profile of Mood States (POMS)
Time frame: Experimental session approximately six hours after drug administration
Assesses current mood state
Profile of Mood States (POMS)
Time frame: Day prior to each experimental session
Assesses current mood state
Profile of Mood States (POMS)
Time frame: Day after each experimental session
Assesses current mood state
19 secondary outcomes
Interpersonal closeness measure
Time frame: Day prior to experimental session
Interpersonal closeness measure
Time frame: Day of experimental session approximately six hours post-drug administration
Interpersonal closeness measure
Time frame: Day after each experimental session
Brief Symptom Inventory (BSI)
Time frame: Day prior to each experimental session
Brief Symptom Inventory (BSI)
Time frame: Day of experimental session prior to drug administration
Brief Symptom Inventory (BSI)
Time frame: Day of experimental session approximately five to six hours after drug administration
Brief Symptom Inventory (BSI)
Time frame: Day after each experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Time frame: Day prior to each experimental session
Neuroticism Extroversion Openness Personality Inventory
Time frame: At baseline
Neuroticism Extroversion Openness Personality Inventory
Time frame: Two months after the second experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Time frame: Day after each experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Time frame: One month after the second experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Time frame: Two months after the second experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Time frame: Day six and 12 of telephone contact after second experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Time frame: Day of each experimental session prior to drug administration
Columbia Suicide Severity Rating Scale (adapted C-SSRS)
Time frame: Day of each experimental session approximately five to six hours after drug administration
Blood pressure (SBP/DBP)
Time frame: Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours
Heart rate (pulse)
Time frame: Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours
Body temperature
Time frame: Approximately every 60 minutes for each experimental session
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 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.
Michael M Mithoefer, MD study director
Resilient Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing midomafetamine HCl in people with Psychological Effects of Study Drug, run by Resilient Pharmaceuticals at 3 sites 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 9 inclusion and 8 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 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 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 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?
Profile of Mood States (POMS) (time frame: Experimental session approximately six hours after drug administration). The study lists 3 primary outcomes in all. 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.