Effects of Hallucinogens and Other Drugs on Mood and Performance

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Roland Griffiths, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02033707
First received: December 30, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Hallucinogens and psychoactive substances
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Phase I Study Characterizing Effects of Hallucinogens and Other Drugs on Mood and Performance

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Rating of "Drug Liking" on the End of Day Questionnaire [ Time Frame: Completed at the end of the experimental session (approximately 8 hours after capsule administration) ] [ Designated as safety issue: No ]
    Volunteer-completed questionnaire assesses the subjective liking of the drug condition for the session


Secondary Outcome Measures:
  • Hallucinogen Rating Scale [ Time Frame: Completed at the end of the experimental session (approximately 8 hours after capsule administration) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 20
Study Start Date: April 2014
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Hallucinogens
  • Sedatives & anxiolytics
  • Antihistamines
  • Stimulants
  • Opioids
  • Alcohol
  • Scopolamine
  • Nicotine
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:
  • Hallucinogens
  • Sedatives & anxiolytics
  • Antihistamines
  • Stimulants
  • Opioids
  • Alcohol
  • Scopolamine
  • Nicotine

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.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be 21 to 50 years old
  • Have given written informed consent
  • Have a high school level of education
  • 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 DXM and psilocybin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033707

Contacts
Contact: Ethan Hurwitz 410-550-3074 ehurwit2@jhmi.edu
Contact: Theresa Carbonaro, Ph.D. 410-550-2983 tcarbon4@jhu.edu

Locations
United States, Maryland
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Theresa Carbonaro, Ph.D.    410-550-2983    tcarbon4@jhu.edu   
Principal Investigator: Roland R Griffiths, Ph.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Roland R Griffiths, Ph.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Roland Griffiths, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02033707     History of Changes
Other Study ID Numbers: NA_00082804
Study First Received: December 30, 2013
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Hallucinogen
Cognitive effects
Subjective effects

Additional relevant MeSH terms:
Central Nervous System Stimulants
Histamine Antagonists
Histamine H1 Antagonists
Scopolamine
Butylscopolammonium Bromide
Nicotine
Hallucinogens
Hypnotics and Sedatives
Anti-Anxiety Agents
Analgesics, Opioid
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Adjuvants, Anesthesia
Parasympatholytics
Psychotropic Drugs
Central Nervous System Depressants
Ganglionic Stimulants
Nicotinic Agonists
Cholinergic Agonists

ClinicalTrials.gov processed this record on July 24, 2014