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Effects of Hallucinogens and Other Drugs on Mood and Performance

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ClinicalTrials.gov Identifier: NCT02033707
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE December 30, 2013
First Posted Date  ICMJE January 13, 2014
Last Update Posted Date May 16, 2019
Study Start Date  ICMJE April 2014
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
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) ]
Volunteer-completed questionnaire assesses the subjective liking of the drug condition for the session
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
Hallucinogen Rating Scale [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Hallucinogens and Other Drugs on Mood and Performance
Official Title  ICMJE Phase I Study Characterizing Effects of Hallucinogens and Other Drugs on Mood and Performance
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Male volunteers
    Hallucinogens and psychoactive substances will be administered via capsule. Results will be compared between male and female participants.
    Intervention: Drug: Hallucinogens and psychoactive substances
  • Experimental: Female volunteers
    Hallucinogens and psychoactive substances will be administered via capsule. Results will be compared between male and female participants.
    Intervention: Drug: Hallucinogens and psychoactive substances
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02033707
Other Study ID Numbers  ICMJE NA_00082804
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roland R Griffiths, Ph.D. Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP