Effects of Hallucinogens and Other Drugs on Mood and Performance



Status:Active, not recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:21 - 50
Updated:2/17/2019
Start Date:April 2014
End Date:January 2021

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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.

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.

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
We found this trial at
1
site
Baltimore, Maryland 21224
Principal Investigator: Roland R Griffiths, Ph.D.
Phone: 410-550-2983
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from
Baltimore, MD
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