Ignite Creation Date:
2024-05-06 @ 10:09 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03181763
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2017-06-05
Brief Title:
Evaluation of MDMA on Startle Response
Sponsor:
Lykos Therapeutics
Organization:
Lykos Therapeutics
Study Overview
Official Title:
Evaluation of 34-methylenedioxymethamphetamine MDMA on Startle Response
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine how the drug methylenedioxymethamphetamine MDMA impacts response to different types of memory in humans compared to placebo 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 and it may do so in part by influencing response to memories This study will enroll healthy adults who will need to come in for three visits over four days At visit 1 participants will undergo a 1-hour startle test The startle test measures eye-blink response to loud sounds After this the participant will also view different colored shapes presented on a computer monitor While watching the computer monitor the participant will experience several brief blasts of air directed at the throat while eye-blink is measured with sensors under the eye The following day at visit 2 participants will be randomized to receive placebo or 100 mg MDMA and will complete tasks similar to the ones completed the previous day Participants who agree to do so will have blood drawn to measure the neurohormones oxytocin and cortisol and brain-derived neurotrophic factor BDNF before and after drug administration on Visit 2 The researchers will measure pulse blood pressure and temperature once before and seven times after receiving MDMA or placebo and study participants will complete a questionnaire about their experience Two days after receiving MDMA or placebo participants will return for a third visit to complete similar tasks to previous visits This study will also measure sleep through a sleep diary and actigraphy which is a device worn on the wrist like a watch that records movement during sleep and lets researchers see how much sleep a person is getting
Detailed Description:
This is a randomized blinded placebo-controlled Phase 1 study that aims to evaluate the impact of 34-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 afterwardsThe 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
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 afterwardsThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None