Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2)
NCT04073433 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2024-10-31
Summary
The goal of this clinical trial is to study MDMA-assisted therapy in healthy volunteers and provide training of therapists. The main question it aims to answer is:
Does MDMA-assisted therapy result in personal and professional benefits?
Participants will have a non-drug preparatory session prior to each experimental session and an integrative session after each experimental session.
Conditions
- Psychological Effects of Study Drug
Interventions
- DRUG
-
Midomafetamine HCl
120 mg midomafetamine HCl
- BEHAVIORAL
-
Therapy
Non-directive therapy conducted during MDMA-assisted therapy session
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Marcela Ot'alora · Private Practice
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-12-31
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
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