Startle Response
Conditions
Keywords
MDMA, Startle response, sleep, Oxytocin
Brief summary
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.
Detailed description
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.
Interventions
DRUGPlacebo
Participants will receive inactive placebo on their second visit.
DRUGMidomafetamine
Participants will receive 100 mg midomafetamine HCl on their second visit
BEHAVIORALAcoustic startle
Startle assessment
Sponsors
Lykos Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Blinded, placebo between group; all participants undergo fear conditioning, with half randomized to receive 100 mg MDMA and half receiving inactive placebo
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EMG of right orbicularis oculi muscle | Four days post-enrollment | Description: Measure of startle response to noise after fear extinction training |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body temperature 1 h 45 minutes post-drug | 1 hour 45 minutes post-drug | Body temperature measured 1 hour 45 minutes after MDMA or placebo administration |
| Body temperature 3 hours post-drug | 3 hours post-drug | Body temperature measured 3 hours after MDMA or placebo administration |
| Pulse 6 h post-drug | 6 hours post-drug | Pulse (assessing heart rate) measured 6 hours after MDMA or placebo administration |
| Body temperature pre-drug | 5 minutes pre-drug | Body temperature measured before MDMA or placebo administration |
| Body temperature 45 minutes post-drug | 45 minutes post-drug | Body temperature measured 45 minutes after MDMA or placebo administration |
| Systolic blood pressure pre-drug | 5 minutes pre-drug | Systolic blood pressure measured prior to administration of MDMA or placebo |
| Systolic blood pressure 45 min post-drug | 45 minutes post-drug | Systolic blood pressure measured 45 minutes after MDMA or placebo administration |
| Systolic blood pressure 1 h 15 min post-drug | 1 hour 15 minutes post drug | Systolic blood pressure measured 1 hour 15 minutes after MDMA or placebo administration |
| Systolic blood pressure 1 h 45 min post-drug | 1 hour 45 minutes post drug | Systolic blood pressure measured 1 hour 45 minutes after MDMA or placebo administration |
| Systolic blood pressure 3 h post-drug | 3 hours post-drug | Systolic blood pressure measured 3 hours after MDMA or placebo administration |
| Systolic blood pressure 4 h post-drug | 4 hours post-drug | Systolic blood pressure measured 4 hours after MDMA or placebo administration |
| Systolic blood pressure 5 h post-drug | 5 hours post-drug | Systolic blood pressure measured 5 hours after MDMA or placebo administration |
| Systolic blood pressure 6 h post-drug | 6 hours post-drug | Systolic blood pressure measured 6 hours after MDMA or placebo administration |
| Diastolic blood pressure pre-drug | 5 minutes pre-drug | Diastolic blood pressure measured prior to MDMA or placebo administration |
| Diastolic blood pressure 45 min post-drug | 45 minutes post-drug | Diastolic blood pressure measured 45 minutes after MDMA or placebo administration |
| Diastolic blood pressure 1 h 15 min post-drug | 1 hour 15 minutes post-drug | Diastolic blood pressure measured 1 h 15 minutes after MDMA or placebo administration |
| Diastolic blood pressure 1 h 45 min post-drug | 1 hour 45 minutes post drug | Diastolic blood pressure measured 1 h 45 minutes after MDMA or placebo administration |
| Diastolic blood pressure 3 h post-drug | 3 hours post-drug | Diastolic blood pressure measured 3 hours after MDMA or placebo administration |
| Diastolic blood pressure 4 hours post-drug | 4 hours post-drug | Diastolic blood pressure measured 4 hours after MDMA or placebo administration |
| Diastolic blood pressure 5 hours post-drug | 5 hours post-drug | Diastolic blood pressure measured 5 hours after MDMA or placebo administration |
| Diastolic blood pressure 6 hours post-drug | 6 hours post-drug | Diastolic blood pressure measured 6 hours after MDMA or placebo administration |
| Pulse pre-drug | 5 minutes pre-drug | Pulse (assessing heart rate) measured prior to MDMA or placebo administration |
| Pulse 45 min post-drug | 45 minutes post-drug | Pulse (assessing heart rate) measured 45 min after MDMA or placebo administration |
| Pulse 1 h 15 min post-drug | 1 hour 15 minutes post-drug | Pulse (assessing heart rate) measured 1 hour 15 min after MDMA or placebo administration |
| Pulse 1 h 45 min post-drug | 1 hour 45 minutes post-drug | Pulse (assessing heart rate) measured 1 hour 45 min after MDMA or placebo administration |
| Pulse 3 h post-drug | 3 hours post-drug | Pulse (assessing heart rate) measured 3 hours after MDMA or placebo administration |
| Pulse 4 h post-drug | 4 hours post-drug | Pulse (assessing heart rate) measured 4 hours after MDMA or placebo administration |
| Pulse 5 h post-drug | 5 hours post-drug | Pulse (assessing heart rate) measured 5 hours after MDMA or placebo administration |
| Body temperature 4 hours post-drug | 4 hours post-drug | Body temperature measured 4 hours after MDMA or placebo administration |
| Body temperature 5 hours post-drug | 5 hours post-drug | Body temperature measured 5 hours after MDMA or placebo administration |
| Body temperature 6 hours post-drug | 6 hours post-drug | Body temperature measured 6 hours after MDMA or placebo administration |
| Plasma oxytocin (OT) levels predrug | 5 min prior to drug administration | In people who agree to it, blood collected to assess levels of oxytocin prior to MDMA or placebo administration on day of drug administration |
| Plasma oxytocin (OT) levels 5 min post-drug | 5 min post-drug administration | In people who agree to it, blood collected to assess levels of oxytocin approximately 5 minutes after MDMA or placebo administration |
| Plasma oxytocin (OT) levels 20 min post-drug | 20 min post-drug administration | In people who agree to it, blood collected to assess levels of oxytocin approximately 20 minutes after MDMA or placebo administration |
| Plasma oxytocin (OT) levels 95 min post-drug | 95 min post-drug administration | 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 |
| Body temperature 1 h 15 minutes post-drug | 1 hour 15 minutes post-drug | Body temperature measured 1 hour 15 minutes after MDMA or placebo administration |
| Plasma oxytocin (OT) levels 185 min post-drug | 185 min post-drug administration | In people who agree to it, blood collected to assess levels of oxytocin approximately 185 minutes after MDMA or placebo administration |
| Plasma oxytocin (OT) levels 200 min post-drug | 200 min post-drug administration | In people who agree to it, blood collected to assess levels of oxytocin approximately 200 minutes after MDMA or placebo administration |
| Plasma oxytocin (OT) levels 240 min post-drug | 240 min post-drug administration | In people who agree to it, blood collected to assess levels of oxytocin approximately 240 minutes after MDMA or placebo administration |
| Plasma oxytocin (OT) levels 300 min post-drug | 300 min post-drug administration | In people who agree to it, blood collected to assess levels of oxytocin approximately 300 minutes after MDMA or placebo administration |
| Plasma oxytocin (OT) levels 110 min post-drug | 110 min post-drug administration | In people who agree to it, blood collected to assess levels of oxytocin approximately 110 minutes after MDMA or placebo administration |
Countries
United States
Outcome results
None listed