Investigation of Psychedelic Effects in Psychoactive Substances
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age25-55
SponsorJohns Hopkins University
About this trial
The aim of this double-blind, placebo-controlled, within-subjects study is to determine whether other psychoactive substances can produce experiences akin to those seen with classic psychedelics. Screening involves a medical and psychiatric examination, including blood draw, history and physical, interviews, and questionnaires. Eligible participants will then be asked to complete up to 6 experimental drug administration session during which the participants will potentially receive and report on the subjective effects of 6 different psychoactive substances or inactive placebo. Drug assignment for some sessions will be randomized (like flipping a count or rolling a pair of dice), and both participants and study staff will be blind to the drug condition on any given day. Participants will also complete 2 preparation sessions (4 hours total) before the first experimental session, and follow-up visits after each session to discuss and debrief on the participants subjective experience.
Eligibility criteria
Qualifiers
Be 25 to 55 years old
BMI between 18 and 34 kg/m2
Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the subject does not usually consume caffeinated beverages, he or she must agree not to do so on session days
Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each drug administration. Exceptions include daily use of caffeine and nicotine.
Disqualifiers
Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control (e.g. oral contraceptives, intrauterine device)
Cardiovascular conditions-coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), or transient ischemic attack-that in the clinical opinion of the screening physician or mid-level provider would put the participant at an especially high risk for adverse effects from the study.
Epilepsy with history of seizures
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
Trial design
Treatments tested in this trial
- Placebo
- Psilocybin
- Ketamine
- Dextromethorphan (DXM)
- Dimethyltryptamine (DMT)
- Methylenedioxymethamphetamine (MDMA)
- Tetrahydrocannabinol (THC)
Treatment groups
50 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov