Effects of Hallucinogens and Other Drugs on Mood and Performance

Phase I Study Characterizing Effects of Hallucinogens and Other Drugs on Mood and Performance

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Hallucinogens and psychoactive substances

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Male volunteers; Hallucinogens and psychoactive substances will be administered via capsule. Results will be compared between male and female participants.	Drug: Hallucinogens and psychoactive substances; One of the following or placebo will be given: Hallucinogens: DMT, 4-phosphoryloloxy-N-diethyltryptamine, dipropyltryptamine (DPT), ketamine, dextromethorphan, mescaline, PCP, psilocybin, salvinorin-A, LSD, d-lysergic acid amide (LSA), MDMA, cannabis Sedatives/anxiolytics: alprazolam, diazepam, lorazepam, secobarbital, temazepam, triazolam, zolpidem Antihistamines: diphenhydramine, chlorpheniramine Stimulants: d-amphetamine, caffeine, ephedrine, methylphenidate, diethylproprion Opioids: heroin, morphine, oxycodone, hydrocodone, methadone, codeine Other: alcohol, scopolamine, nicotine Each volunteer will receive a hallucinogen on at least one of five sessions. More drugs are listed than will be administered to increase the degree to which volunteers are "blind" to the drugs being studied. It is important that the volunteer and research staff be blinded to specific drug conditions to minimize confounding the results with expectations about the nature of drug effects.; Other Names: Scopolamine; Nicotine; Alcohol; Hallucinogens; Sedatives & anxiolytics; Antihistamines; Stimulants; Opioids
Experimental: Female volunteers; Hallucinogens and psychoactive substances will be administered via capsule. Results will be compared between male and female participants.	Drug: Hallucinogens and psychoactive substances; One of the following or placebo will be given: Hallucinogens: DMT, 4-phosphoryloloxy-N-diethyltryptamine, dipropyltryptamine (DPT), ketamine, dextromethorphan, mescaline, PCP, psilocybin, salvinorin-A, LSD, d-lysergic acid amide (LSA), MDMA, cannabis Sedatives/anxiolytics: alprazolam, diazepam, lorazepam, secobarbital, temazepam, triazolam, zolpidem Antihistamines: diphenhydramine, chlorpheniramine Stimulants: d-amphetamine, caffeine, ephedrine, methylphenidate, diethylproprion Opioids: heroin, morphine, oxycodone, hydrocodone, methadone, codeine Other: alcohol, scopolamine, nicotine Each volunteer will receive a hallucinogen on at least one of five sessions. More drugs are listed than will be administered to increase the degree to which volunteers are "blind" to the drugs being studied. It is important that the volunteer and research staff be blinded to specific drug conditions to minimize confounding the results with expectations about the nature of drug effects.; Other Names: Scopolamine; Nicotine; Alcohol; Hallucinogens; Sedatives & anxiolytics; Antihistamines; Stimulants; Opioids

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hallucinogen Rating Scale	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	Completed at the end of the experimental session (approximately 8 hours after capsule administration)

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Roland R Griffiths, Ph.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: December 30, 2013
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 13, 2014

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Hallucinogen; Cognitive effects; Subjective effects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antiemetics; Gastrointestinal Agents; Psychotropic Drugs; Adjuvants, Anesthesia; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Mydriatics; Nicotine; Scopolamine; Hallucinogens
• Other Study ID Numbers: NA_00082804