Investigation of Psychedelic Effects in Psychoactive Substances

ConditionPsychedelic Effects in Healthy Volunteers

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Placebo
Drug
inactive substance
Psilocybin
Drug
active comparator for psychedelic effects
Ketamine
Drug
psychoactive substance
Dextromethorphan (DXM)
Drug
psychoactive substance
Dimethyltryptamine (DMT)
Drug
psychoactive substance
Methylenedioxymethamphetamine (MDMA)
Drug
psychoactive substance
Tetrahydrocannabinol (THC)
Drug
psychoactive substance

Treatment groups

50 Participants

are divided into 3 treatment groups

Group A: PlaceboPlacebo comparator 1 intervention

Group B: PsilocybinActive comparator 1 intervention

Group C: Other psychoactive drugsExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

Mystical Experience Questionnaire (MEQ-30)

The MEQ is a 30-item self-report instrument intended to assess psychedelic-specific acute subjective effects of psychoactive drugs. At the end of each experimental session, participants will be instructed to rate each of the items of the MEQ relative to the experiences that the participant encountered during the course of the drug administration session. The total score on all items is then calculated as the primary outcome measure for each experimental session. Scores range from 0 to 150 on this measure with higher scores reflecting more mystical experience

Time frame

Week 2, Week 7

Secondary outcomes

Drug Effects Questionnaire (DEQ)

The DEQ is a self-report instrument intended to assess a range of psychoactive drug effects. Individual items include ratings of abuse-related drug effects (e.g. drug effect, good effect, bad effect, liking) and behavioral/mood states often associated with drug intoxication. The DEQ will be rated at baseline prior to the first session, and then at the end of each experimental session. The the primary outcomes for each session will be DEQ score change from baseline. Scores range from 0 to 200 on this measure where 0 is the least impactful effect.

Time frame

Week 2, Week 7

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Source ClinicalTrials.gov

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