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Healthy | Effects of Hallucinogens and Other Drugs on Mood and Performance

Healthy research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Hallucinogens and psychoactive substancesOne 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Active, not recruiting

Start Date: April 2014

Completed Date: January 2020

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Rating of "Drug Liking" on the End of Day Questionnaire

Secondary Outcome: Hallucinogen Rating Scale

Study sponsors, principal investigator, and references

Principal Investigator: Roland R Griffiths, Ph.D.

Lead Sponsor: Johns Hopkins University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02033707

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