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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg MDMA HCl | Experimental | Participants receive 100 mg MDMA HCl on their second visit |
|
| Placebo | Placebo Comparator | Participants receive inactive placebo on their second visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants will receive inactive placebo on their second visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| EMG of right orbicularis oculi muscle | Description: Measure of startle response to noise after fear extinction training | Four days post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure pre-drug | Systolic blood pressure measured prior to administration of MDMA or placebo | 5 minutes pre-drug |
| Systolic blood pressure 45 min post-drug | Systolic blood pressure measured 45 minutes after MDMA or placebo administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Rothbaum | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30329 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35166140 | Derived | Maples-Keller JL, Norrholm SD, Burton M, Reiff C, Coghlan C, Jovanovic T, Yasinski C, Jarboe K, Rakofsky J, Rauch S, Dunlop BW, Rothbaum BO. A randomized controlled trial of 3,4-methylenedioxymethamphetamine (MDMA) and fear extinction retention in healthy adults. J Psychopharmacol. 2022 Mar;36(3):368-377. doi: 10.1177/02698811211069124. Epub 2022 Feb 15. |
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| ID | Term |
|---|---|
| D007785 | Lactose |
| D018817 | N-Methyl-3,4-methylenedioxyamphetamine |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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Blinded, placebo between group; all participants undergo fear conditioning, with half randomized to receive 100 mg MDMA and half receiving inactive placebo
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| Midomafetamine | Drug | Participants will receive 100 mg midomafetamine HCl on their second visit |
|
|
| Acoustic startle | Behavioral | Startle assessment |
|
|
| 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 | 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 | 1 hour 45 minutes post drug |
| Systolic blood pressure 3 h post-drug | Systolic blood pressure measured 3 hours after MDMA or placebo administration | 3 hours post-drug |
| Systolic blood pressure 4 h post-drug | Systolic blood pressure measured 4 hours after MDMA or placebo administration | 4 hours post-drug |
| Systolic blood pressure 5 h post-drug | Systolic blood pressure measured 5 hours after MDMA or placebo administration | 5 hours post-drug |
| Systolic blood pressure 6 h post-drug | Systolic blood pressure measured 6 hours after MDMA or placebo administration | 6 hours post-drug |
| Diastolic blood pressure pre-drug | Diastolic blood pressure measured prior to MDMA or placebo administration | 5 minutes pre-drug |
| Diastolic blood pressure 45 min post-drug | Diastolic blood pressure measured 45 minutes after MDMA or placebo administration | 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 | 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 | 1 hour 45 minutes post drug |
| Diastolic blood pressure 3 h post-drug | Diastolic blood pressure measured 3 hours after MDMA or placebo administration | 3 hours post-drug |
| Diastolic blood pressure 4 hours post-drug | Diastolic blood pressure measured 4 hours after MDMA or placebo administration | 4 hours post-drug |
| Diastolic blood pressure 5 hours post-drug | Diastolic blood pressure measured 5 hours after MDMA or placebo administration | 5 hours post-drug |
| Diastolic blood pressure 6 hours post-drug | Diastolic blood pressure measured 6 hours after MDMA or placebo administration | 6 hours post-drug |
| Pulse pre-drug | Pulse (assessing heart rate) measured prior to MDMA or placebo administration | 5 minutes pre-drug |
| Pulse 45 min post-drug | Pulse (assessing heart rate) measured 45 min after MDMA or placebo administration | 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 | 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 | 1 hour 45 minutes post-drug |
| Pulse 3 h post-drug | Pulse (assessing heart rate) measured 3 hours after MDMA or placebo administration | 3 hours post-drug |
| Pulse 4 h post-drug | Pulse (assessing heart rate) measured 4 hours after MDMA or placebo administration | 4 hours post-drug |
| Pulse 5 h post-drug | Pulse (assessing heart rate) measured 5 hours after MDMA or placebo administration | 5 hours post-drug |
| Pulse 6 h post-drug | Pulse (assessing heart rate) measured 6 hours after MDMA or placebo administration | 6 hours post-drug |
| Body temperature pre-drug | Body temperature measured before MDMA or placebo administration | 5 minutes pre-drug |
| Body temperature 45 minutes post-drug | Body temperature measured 45 minutes after MDMA or placebo administration | 45 minutes post-drug |
| Body temperature 1 h 15 minutes post-drug | Body temperature measured 1 hour 15 minutes after MDMA or placebo administration | 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 | 1 hour 45 minutes post-drug |
| Body temperature 3 hours post-drug | Body temperature measured 3 hours after MDMA or placebo administration | 3 hours post-drug |
| Body temperature 4 hours post-drug | Body temperature measured 4 hours after MDMA or placebo administration | 4 hours post-drug |
| Body temperature 5 hours post-drug | Body temperature measured 5 hours after MDMA or placebo administration | 5 hours post-drug |
| Body temperature 6 hours post-drug | Body temperature measured 6 hours after MDMA or placebo administration | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 300 min post-drug administration |
| D000073893 |
| Sugars |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |