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3,4-methylenedioxymethamphetamine for Psychological Effects (MT-1 Trial)

Phase 1
Waitlist Available
Research Sponsored by Lykos Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours
Awards & highlights

MT-1 Trial Summary

This trial will compare the effects of the drug MDMA to placebo on mood and psychological experience in people trained to practice MDMA-assistant psychotherapy. The study will be double-blind, meaning that neither the subjects nor the investigators will know who is receiving MDMA and who is receiving placebo.

MT-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day after each experimental session
This trial's timeline: 3 weeks for screening, Varies for treatment, and day after each experimental session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Profile of Mood States (POMS)
Secondary outcome measures
Blood pressure (SBP/DBP)
Body temperature
Brief Symptom Inventory (BSI)
+4 more

MT-1 Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 3,4-methylenedioxymethamphetamineActive Control1 Intervention
Participant receives 120 mg MDMA possibly followed by 40 mg MDMA during a day-long experimental session. Mood, interpersonal closeness, psychological symptoms are measured before, during and after the session, and vital signs (blood pressure, heart rate, body temperature) are measured during the session.
Group II: Lactose (Inactive Placebo)Placebo Group1 Intervention
Participant receives inactive placebo during day-long experimental session. Mood, interpersonal closeness, psychological symptoms are measured before, during and after the session, and vital signs (blood pressure, heart rate, body temperature) are measured during the session.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Lykos TherapeuticsLead Sponsor
41 Previous Clinical Trials
1,532 Total Patients Enrolled
MAPS Public Benefit CorporationLead Sponsor
29 Previous Clinical Trials
1,195 Total Patients Enrolled
Multidisciplinary Association for Psychedelic StudiesLead Sponsor
39 Previous Clinical Trials
1,506 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers
2011. "Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01404754.
~8 spots leftby Apr 2025
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