Evaluation of MDMA on Startle Response

This is a randomized, blinded, placebo-controlled Phase 1 study that aims to evaluate the impact of 3,4-methylenedioxymethamphetamine (MDMA) on startle response.

Topic Healthy Subjects
Compound Placebo MDMA
Country United States of America
Visit trial
Status Completed
Results Published Yes
Start date 21 September 2017
End date 04 November 2020
Chance of happening 100%
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 34
Sex All
Age 21- 55
Therapy No

Trial Details

This is a randomized, blinded, placebo-controlled Phase 1 study that aims to evaluate the impact of 3,4-methylenedioxymethamphetamine (MDMA) on startle response . MDMA is an experimental drug and is illegal to possess outside of research; when sold illegally it is referred to as Ecstasy or Molly (material supposedly containing MDMA). MDMA may make it easier to face unpleasant memories and reduce anxiety. 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 task. 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 Fittbit during study participation. The primary objective of this study is to assess whether MDMA affects startle response

NCT Number NCT03181763

Sponsors & Collaborators

MAPS
MAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.

Papers

A randomized controlled trial of 3,4-methylenedioxymethamphetamine (MDMA) and fear extinction retention in healthy adults
This double-blind placebo-controlled trial (n=34) assessed the effects of MDMA (100mg) following a fear acquisition session, an extinction training session and retention in healthy subjects. There was no difference between extinction training and retention between groups. However, significantly more participants in the MDMA group retained extinction learning compared to the placebo group (p = 0.007).

Data attribution

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