Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactose (Inactive Placebo) | Placebo Comparator | Participant receives inactive placebo during day-long experimental session. |
|
| 3,4-methylenedioxymethamphetamine | Active Comparator | Participant receives 120 mg midomafetamine HCl possibly followed by 40 mg midomafetamine HCl during a day-long experimental session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactose (inactive placebo) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Mood States (POMS) | Assesses current mood state | Experimental session approximately six hours after drug administration |
| Profile of Mood States (POMS) | Assesses current mood state | Day prior to each experimental session |
| Profile of Mood States (POMS) | Assesses current mood state | Day after each experimental session |
| Measure | Description | Time Frame |
|---|---|---|
| Interpersonal closeness measure | Visual analog scale assessing emotional closeness to self and four other targets | Day prior to experimental session |
| Interpersonal closeness measure | Visual analog scale assessing emotional closeness to self and four other targets |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael M Mithoefer, MD | Resilient Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aguazul Bluewater, Inc. | Boulder | Colorado | 80304 | United States | ||
| Santa Fe MDMA Therapy Training, LLC |
Not provided
| ID | Term |
|---|---|
| D007785 | Lactose |
| D018817 | N-Methyl-3,4-methylenedioxyamphetamine |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| midomafetamine HCl | Drug | 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. |
|
|
| 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 | Day after each experimental session |
| Brief Symptom Inventory (BSI) | Self-report measure assessing psychiatric symptoms | Day prior to each experimental session |
| Brief Symptom Inventory (BSI) | Self-report measure assessing psychiatric symptoms | Day of experimental session prior to drug administration |
| Brief Symptom Inventory (BSI) | Self-report measure assessing psychiatric symptoms | Day of experimental session approximately five to six hours after drug administration |
| Brief Symptom Inventory (BSI) | Self-report measure assessing psychiatric symptoms | Day after each experimental session |
| Columbia Suicide Severity Rating Scale (adapted C-SSRS) | Clinician-administered measure of suicide risk | 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 | At baseline |
| Neuroticism Extroversion Openness Personality Inventory | Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness | Two months after the second experimental session |
| Columbia Suicide Severity Rating Scale (adapted C-SSRS) | Clinician-administered measure of suicide risk | Day after each experimental session |
| Columbia Suicide Severity Rating Scale (adapted C-SSRS) | Clinician-administered measure of suicide risk | One month after the second experimental session |
| Columbia Suicide Severity Rating Scale (adapted C-SSRS) | Clinician-administered measure of suicide risk | Two months after the second experimental session |
| Columbia Suicide Severity Rating Scale (adapted C-SSRS) | Clinician-administered measure of suicide risk | 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 | Day of each experimental session prior to drug administration |
| Columbia Suicide Severity Rating Scale (adapted C-SSRS) | Clinician-administered measure of suicide risk | 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. | 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. | 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. | Approximately every 60 minutes for each experimental session |
| Santa Fe |
| New Mexico |
| 87508 |
| United States |
| Zen Therapeutic Solutions | Mt. Pleasant | South Carolina | 29464 | United States |
| D000073893 |
| Sugars |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |