Evaluation of MDMA on Startle Response

• Status: Completed
• Trial end date: 2020-11-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Multidisciplinary Association for Psychedelic Studies
• Treatments: N-Methyl-3,4-methylenedioxyamphetamine

Criteria

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.