Evaluation of MDMA on Startle Response

Resilient Pharmaceuticals34 enrolled

Overview

The goal of this clinical trial is to learn if MDMA impacts startle response in healthy participants. The main question it aims to answer is: Does MDMA impact participant's performance on a startle test? Researchers will compare healthy volunteers who have taken MDMA to those who have taken placebo. Participants will first undergo a 1-hour startle test. The next day, they will be randomized to receive either MDMA or placebo followed by another startle test and vitals signs and blood measurements. Participants will return the next day for a final startle test. Their sleep will be tracked by a Fitbit device.

This is a randomized, blinded, placebo-controlled Phase 1 study that aims to evaluate the impact of 3,4-methylenedioxymethamphetamine (MDMA) on startle response. This study will enroll healthy participants. At Visit 1, all participants will undergo a 1-hour startle test. Acoustic startle will be measured through assessing eye-blink response from the orbicularis oculi muscles in response to a 106 dB noise, using sensors under the eye. While watching the computer monitor, the participant will also experience several brief blasts of air directed at the throat. At Visit 2 (24 hours later), participants will be randomized to receive 100 mg of MDMA or inactive placebo, after which they will undergo another startle test. Participants enrolled in the study who agree to do this will have their blood drawn to measure levels of oxytocin, and possibly other hormones or proteins, such as cortisol or brain-derived neurotrophic factor (BDNF). Measuring oxytocin will be blind to condition, and the decision will happen before randomization to either condition. Blood will be drawn before MDMA or placebo administration, and eight times afterwards.The researchers will measure pulse, blood pressure and temperature once before and six times after receiving MDMA or placebo, and study participants will complete a questionnaire about their experience. At Visit 3, participants will return for a final startle test and recall task. Sleep will be measured via self-report and Fitbit during study participation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

Conditions

Startle Response

Interventions

PlaceboDRUG

Participants will receive inactive placebo on their second visit.

MidomafetamineDRUG

Participants will receive 100 mg midomafetamine HCl on their second visit

Acoustic startleBEHAVIORAL

Startle assessment

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Persons aged 21 to 55. * Ability to visually read and understand English language. * Live within in metro Atlanta area * Previously used MDMA in a recreational or research setting * If a person is of childbearing potential (able to bear children), they must have a negative pregnancy test at study entry and prior to the Experimental Session. They must agree to use adequate birth control through 10 days after the last dose of MDMA. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Not of childbearing potential is defined as permanent sterilization, postmenopausal, or male. * (For sub-study measuring serum oxytocin) Willing to have periodic blood draws Exclusion Criteria: * Upon review of medical or psychiatric history, have any current or past diagnosis that would be considered a risk to participating in the study. * Are abusing illegal drugs. * Current use of any psychoactive medications, including antidepressants, mood stabilizers, sedatives, stimulants, antipsychotics, anxiolytics, or beta-blockers * Are not able to give adequate informed consent. * Uncontrolled hypertension, or clinically significant cardiac arrhythmia, as detected by electrocardiogram. * Currently pregnant or breast-feeding. * History of acute angle glaucoma. * Hearing impairment as assessed by audiometer; unable to detect tones below 40 dB in right or left ear.

Locations (1)

Emory University

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

EMG of right orbicularis oculi muscle

Description: Measure of startle response to noise after fear extinction training

Time frame: Four days post-enrollment

Secondary Outcomes

Systolic blood pressure pre-drug

Systolic blood pressure measured prior to administration of MDMA or placebo

Time frame: 5 minutes pre-drug

Systolic blood pressure 45 min post-drug

Systolic blood pressure measured 45 minutes after MDMA or placebo administration

Time frame: 45 minutes post-drug

Systolic blood pressure 1 h 15 min post-drug

Systolic blood pressure measured 1 hour 15 minutes after MDMA or placebo administration

Time frame: 1 hour 15 minutes post drug

Systolic blood pressure 1 h 45 min post-drug

Systolic blood pressure measured 1 hour 45 minutes after MDMA or placebo administration

Time frame: 1 hour 45 minutes post drug

Systolic blood pressure 3 h post-drug

Systolic blood pressure measured 3 hours after MDMA or placebo administration

Time frame: 3 hours post-drug

Systolic blood pressure 4 h post-drug

Systolic blood pressure measured 4 hours after MDMA or placebo administration

Time frame: 4 hours post-drug

Systolic blood pressure 5 h post-drug

Systolic blood pressure measured 5 hours after MDMA or placebo administration

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 5 hours post-drug

Systolic blood pressure 6 h post-drug

Systolic blood pressure measured 6 hours after MDMA or placebo administration

Time frame: 6 hours post-drug

Diastolic blood pressure pre-drug

Diastolic blood pressure measured prior to MDMA or placebo administration

Time frame: 5 minutes pre-drug

Diastolic blood pressure 45 min post-drug

Diastolic blood pressure measured 45 minutes after MDMA or placebo administration

Time frame: 45 minutes post-drug

Diastolic blood pressure 1 h 15 min post-drug

Diastolic blood pressure measured 1 h 15 minutes after MDMA or placebo administration

Time frame: 1 hour 15 minutes post-drug

Diastolic blood pressure 1 h 45 min post-drug

Diastolic blood pressure measured 1 h 45 minutes after MDMA or placebo administration

Time frame: 1 hour 45 minutes post drug

Diastolic blood pressure 3 h post-drug

Diastolic blood pressure measured 3 hours after MDMA or placebo administration

Time frame: 3 hours post-drug

Diastolic blood pressure 4 hours post-drug

Diastolic blood pressure measured 4 hours after MDMA or placebo administration

Time frame: 4 hours post-drug

Diastolic blood pressure 5 hours post-drug

Diastolic blood pressure measured 5 hours after MDMA or placebo administration

Time frame: 5 hours post-drug

Diastolic blood pressure 6 hours post-drug

Diastolic blood pressure measured 6 hours after MDMA or placebo administration

Time frame: 6 hours post-drug

Pulse pre-drug

Pulse (assessing heart rate) measured prior to MDMA or placebo administration

Time frame: 5 minutes pre-drug

Pulse 45 min post-drug

Pulse (assessing heart rate) measured 45 min after MDMA or placebo administration

Time frame: 45 minutes post-drug

Pulse 1 h 15 min post-drug

Pulse (assessing heart rate) measured 1 hour 15 min after MDMA or placebo administration

Time frame: 1 hour 15 minutes post-drug

Pulse 1 h 45 min post-drug

Pulse (assessing heart rate) measured 1 hour 45 min after MDMA or placebo administration

Time frame: 1 hour 45 minutes post-drug

Pulse 3 h post-drug

Pulse (assessing heart rate) measured 3 hours after MDMA or placebo administration

Time frame: 3 hours post-drug

Pulse 4 h post-drug

Pulse (assessing heart rate) measured 4 hours after MDMA or placebo administration

Time frame: 4 hours post-drug

Pulse 5 h post-drug

Pulse (assessing heart rate) measured 5 hours after MDMA or placebo administration

Time frame: 5 hours post-drug

Pulse 6 h post-drug

Pulse (assessing heart rate) measured 6 hours after MDMA or placebo administration

Time frame: 6 hours post-drug

Body temperature pre-drug

Body temperature measured before MDMA or placebo administration

Time frame: 5 minutes pre-drug

Body temperature 45 minutes post-drug

Body temperature measured 45 minutes after MDMA or placebo administration

Time frame: 45 minutes post-drug

Body temperature 1 h 15 minutes post-drug

Body temperature measured 1 hour 15 minutes after MDMA or placebo administration

Time frame: 1 hour 15 minutes post-drug

Body temperature 1 h 45 minutes post-drug

Body temperature measured 1 hour 45 minutes after MDMA or placebo administration

Time frame: 1 hour 45 minutes post-drug

Body temperature 3 hours post-drug

Body temperature measured 3 hours after MDMA or placebo administration

Time frame: 3 hours post-drug

Body temperature 4 hours post-drug

Body temperature measured 4 hours after MDMA or placebo administration

Time frame: 4 hours post-drug

Body temperature 5 hours post-drug

Body temperature measured 5 hours after MDMA or placebo administration

Time frame: 5 hours post-drug

Body temperature 6 hours post-drug

Body temperature measured 6 hours after MDMA or placebo administration

Time frame: 6 hours post-drug

Plasma oxytocin (OT) levels predrug

In people who agree to it, blood collected to assess levels of oxytocin prior to MDMA or placebo administration on day of drug administration

Time frame: 5 min prior to drug administration

Plasma oxytocin (OT) levels 5 min post-drug

In people who agree to it, blood collected to assess levels of oxytocin approximately 5 minutes after MDMA or placebo administration

Time frame: 5 min post-drug administration

Plasma oxytocin (OT) levels 20 min post-drug

In people who agree to it, blood collected to assess levels of oxytocin approximately 20 minutes after MDMA or placebo administration

Time frame: 20 min post-drug administration

Plasma oxytocin (OT) levels 95 min post-drug

In people who agree to it, blood collected to assess levels of oxytocin approximately 95 minutes (approximately 1.5 h) after MDMA or placebo administration

Time frame: 95 min post-drug administration

Plasma oxytocin (OT) levels 110 min post-drug

In people who agree to it, blood collected to assess levels of oxytocin approximately 110 minutes after MDMA or placebo administration

Time frame: 110 min post-drug administration

Plasma oxytocin (OT) levels 185 min post-drug

In people who agree to it, blood collected to assess levels of oxytocin approximately 185 minutes after MDMA or placebo administration

Time frame: 185 min post-drug administration

Plasma oxytocin (OT) levels 200 min post-drug

In people who agree to it, blood collected to assess levels of oxytocin approximately 200 minutes after MDMA or placebo administration

Time frame: 200 min post-drug administration

Plasma oxytocin (OT) levels 240 min post-drug

In people who agree to it, blood collected to assess levels of oxytocin approximately 240 minutes after MDMA or placebo administration

Time frame: 240 min post-drug administration

Plasma oxytocin (OT) levels 300 min post-drug

In people who agree to it, blood collected to assess levels of oxytocin approximately 300 minutes after MDMA or placebo administration

Time frame: 300 min post-drug administration