Effects of Hallucinogens and Other Drugs on Mood and Performance

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Hallucinogens and psychoactive substances

• Registration Number: NCT02033707
• Lead Sponsor: Johns Hopkins University

Brief Summary

This non-treatment study will investigate the effects on mood and performance caused by hallucinogens and other psychoactive compounds.

Detailed Description

Twenty volunteers between 21-50 years old will each participate in 16 total sessions, including sessions for: screening, preparation, experiment/drug, immediate follow-ups, a 1-month follow-up and 1 post completion urine collection. On each of five experimental session participants will orally ingest capsules of either a placebo or varying doses of one of 18 different psychoactive compounds.

Subjective drug effects will be examined with methods previously used by this laboratory for characterizing the effects of psychoactive substances from a variety different classes. Volunteers will swallow capsules containing various doses of drugs, complete tasks during the session, and rate effects of the drug and complete questionnaires at the end of each session as described below.

Study Timeline

• Study First Submitted: 2013-12-30
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Study Start: 2014-04
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Be 21 to 50 years old
• Have given written informed consent
• Have a high school level of education
• Have a self-reported interest in psychedelic drugs and altered states of consciousness
• Have used classic, serotonergic hallucinogens or dissociative anesthetic hallucinogens (e.g., LSD, psilocybin mushrooms, ayahuasca, ketamine, PCP) without untoward effects. Volunteers must report "liking" of psychedelic and psychedelic-like drugs and report having used hallucinogens at least 5 times in their lifetime and at least once within the last 2 years
• 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 volunteer does not usually consume caffeinated beverages, he or she must agree not to do so on session days
• Cigarette smokers must agree to abstain from smoking on session days from 1 hour before drug administration until at least 6 hours after drug administration
• 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.
• Be healthy and psychologically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
• Agree that for one week before each session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals
• Agree not to take any PRN prescription medications on the mornings of the sessions
• Be willing and able to participate

Exclusion criteria:

• 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
• Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), or TIA in the past year
• Epilepsy with history of seizures
• Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
• Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
• Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting pharmacological effect on serotonin neurons or medications that are MAO inhibitors. For individuals who have intermittent or PRN use of such medications, sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose
• More than 20% outside the upper or lower range of ideal body weight

Psychiatric

Exclusion Criteria

• Current or past history of meeting DSM-IV criteria for schizophrenia, psychotic disorder (unless substance-induced or due to a medical condition), or bipolar I or II disorder
• Current severe obsessive-compulsive disorder, dysthymic disorder, or panic disorder.
• Current, severe, major depression
• Have a first or second degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder
• Currently meets DSM-IV criteria for dissociative disorder, anorexia nervosa, bulimia nervosa, or other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to study compounds

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Male volunteers	Hallucinogens and psychoactive substances	Hallucinogens and psychoactive substances will be administered via capsule. Results will be compared between male and female participants.
Female volunteers	Hallucinogens and psychoactive substances	Hallucinogens and psychoactive substances will be administered via capsule. Results will be compared between male and female participants.

Primary Outcome Measures

Name	Time	Method
Rating of "Drug Liking" on the End of Day Questionnaire	Completed at the end of the experimental session (approximately 8 hours after capsule administration)	Volunteer-completed questionnaire assesses the subjective liking of the drug condition for the session

Secondary Outcome Measures

Name	Time	Method
Hallucinogen Rating Scale	Completed at the end of the experimental session (approximately 8 hours after capsule administration)	This questionnaire has been used in various studies to characterize the profile of subjective and cognitive effects of various types of drugs classified as hallucinogens

Trial Locations

Locations (1)

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States