Effects of Hallucinogens and Other Drugs on Mood and Performance

NCT02033707 | Completed Phase 1 DMC

• 1 other identifier: NA_00082804
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Hallucinogen; Cognitive effects; Subjective effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hallucinogen Rating Scale

  Completed at the end of the experimental session (approximately 8 hours after capsule administration)

Study Arms (2)

Male volunteers

EXPERIMENTAL

Hallucinogens and psychoactive substances will be administered via capsule. Results will be compared between male and female participants.

Drug: Hallucinogens and psychoactive substances

Female volunteers

EXPERIMENTAL

Hallucinogens and psychoactive substances will be administered via capsule. Results will be compared between male and female participants.

Drug: Hallucinogens and psychoactive substances

Interventions

Hallucinogens and psychoactive substances DRUG

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.

Also known as: Hallucinogens, Sedatives & anxiolytics, Antihistamines, Stimulants, Opioids, Alcohol, Scopolamine, Nicotine

Female volunteers; Male volunteers

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Mathai DS, Hilbert S, Sepeda ND, Strickland JC, Griffiths RR, Garcia-Romeu A. Double-Blind Comparison of the Two Hallucinogens Dextromethorphan and Psilocybin: Experience-Dependent and Enduring Psychological Effects in Healthy Volunteers. Psychedelic Med (New Rochelle). 2023 Dec 1;1(4):241-252. doi: 10.1089/psymed.2023.0035. Epub 2023 Dec 13.

  PMID: 38152462 DERIVED

MeSH Terms

Interventions

Hallucinogens; Hypnotics and Sedatives; Anti-Anxiety Agents; Histamine Antagonists; Central Nervous System Stimulants; Analgesics, Opioid; Ethanol; Scopolamine; Nicotine

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Central Nervous System Depressants; Tranquilizing Agents; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Narcotics; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Alcohols; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Roland R Griffiths, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 13, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

US (1)