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Study record managers: refer to the Data Element Definitions if submitting registration or information. LSD is a so-called "classic" or serotonergic hallucinogen or psychedelic. Its psychedelic effects are mainly attributed to its potent partial serotonin 5-HT 5-HT2A receptor agonism. The effects of LSD have been frequently investigated in the past in both healthy participants and patients. Several of these studies described robust and sustained effects of LSD in patients suffering from addiction, anxiety and depression. The acute subjective effects elicited by LSD are mostly positive in humans.
However, psychedelic substances like LSD may also cause unpleasant subjective effects like negative thoughts, rumination, anxiety, panic, paranoia, loss of trust towards other people and perceived loss of control, depending on the dose of LSD used, the personality traits of the person consuming it i. Acute negative psychological effects are considered the main risk of psychedelic substance use in humans. Inducing an overall positive acute response to the psychedelic is critical because several studies showed that a more positive experience is predictive of a greater therapeutic long-term effect of the psychedelic.
Therefore, there is a need for methods which are capable of reducing bad drug effects while enhancing good drug effects to optimize a psychedelic experience. The present study uses 3,4-methylenedioxymethamphetamine MDMA as a pharmacological tool to optimize LSD's effects profile by inducing positive mood. MDMA is an amphetamine derivative which, unlike prototypical amphetamines, predominantly enhances serotonergic neurotransmission via release of 5-HT through the serotonin transporter SERT.
Furthermore, MDMA is known to trigger oxytocin release which may contribute to its effects to increase trust, prosociality, and enhanced empathy. The state of well-being induced by MDMA including increased activation and emotional excitation is known to be associated with a better response to psychedelics. Due to its psychological profile, MDMA could be a reliable pharmacological tool to serve as an optimizer of a psychedelic experience by inducing positive emotions. Layout table for study information Study Type : Interventional Clinical Trial Estimated Enrollment : 24 participants Allocation: Randomized Intervention Model: Crossover Asment Intervention Model Description: Double-blind, placebo-controlled, 4-period cross-over de with four treatment conditions:.
Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information.
Search for terms. Save this study. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details. Last Update Posted : September 8, See Contacts and Locations. Study Description. The acute subjective effects of serotonin 5-HT 2A receptor stimulation with lysergic acid diethylamide LSD in humans are mostly positive. However, negative effects such as anxiety, paranoid thinking or loss of trust towards other people are common effects, depending on the dose administered, the personality traits of the person consuming it set , or the environment in which LSD is taken setting. Negative psychedelic effects may cause acute distress to the subject and acute anxiety has been linked to less favourable long-term outcomes in patients experimentally treated with LSD or similar substances for the treatment of depression.
The 5-HT and oxytocin releaser 3,4-methylenedioxymethamphetamine MDMA reliably induces positive mood up to euphoria, comfort, empathy, and feelings of trust. If administered in combination with LSD, MDMA may increase positive subjective drug effects including positive mood, empathy, and trust and reduce negative emotions and anxiety associated with LSD and overall produce a more positive over negative experience.
Detailed Description:. Arms and Interventions. Mannitol capsules instead of capsules containing MDMA. A moderate dose of mg MDMA will be administered. Pure alcohol instead of an alcoholic solution containing LSD. Outcome Measures. Assessed 18 times on each study day via systolic and diastolic blood pressure. Assessed 18 times on each study day via tympanic body temperature. Assessed 18 times on each study day via blood samples.
Assessed 21 times on each study day via blood samples. Assessed 4 times on each study day via blood samples. Assesses the degree of psychological insight caused by a psychedelic experience through items to be answered on a 6-point Likert scale ranging from 0 "not at all" to 5 "extremely".
Assesses the emergence and intensity of phenomenons occurring in altered states of consciousness on a 6-point Likert scale ranging from 0 "not at all" to 5 "extremely". Assesses the spiritual phenomenons elicited by psychedelic substances through 11 main questions to be answered on a total of 65 sub-ordered mm visual analog scales. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Phase 1. Study Type :. Interventional Clinical Trial. Estimated Enrollment :. Triple Participant, Care Provider, Investigator. Actual Study Start Date :. Estimated Primary Completion Date :. Estimated Study Completion Date :. BASEC August 18, Key Record Dates.Lsd vs mdma
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Effects of MDMA Co-administration on the Response to LSD in Healthy Subjects (LSD-MDMA)