HealthyPhase 1NCT02033707
Effects of Hallucinogens and Other Drugs on Mood and Performance
A Phase 1 study testing Hallucinogens and psychoactive substances in people with Healthy, run by Johns Hopkins University at 1 site in United States.
Trial summary
This non-treatment study will investigate the effects on mood and performance caused by hallucinogens and other psychoactive compounds. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hallucinogens and psychoactive substances
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Feb 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Hallucinogens and psychoactive substances
- Keywords
- Hallucinogen, Cognitive effects, Subjective effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hallucinogens and psychoactive substancesDrug
Also called Hallucinogens, Sedatives & anxiolytics, Antihistamines, Stimulants
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.
| Study group | Role | What they receive |
|---|---|---|
| Male volunteers | Experimental | Hallucinogens and psychoactive substances will be administered via capsule. Results will be compared between male and female participants. Receives: 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. Receives: Drug: Hallucinogens and psychoactive substances |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating of "Drug Liking" on the End of Day Questionnaire
Volunteer-completed questionnaire assesses the subjective liking of the drug condition for the session
Measured: Completed at the end of the experimental session (approximately 8 hours after capsule administration)
Secondary outcomes (1)
Hallucinogen Rating Scale
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
Measured: Completed at the end of the experimental session (approximately 8 hours after capsule administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland R Griffiths, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033707
- Sponsor's protocol ID
- NA_00082804
- Status last verified
- May 2019
- First submitted
- 30 Dec 2013
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38152462
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Characterizing Effects of Hallucinogens and Other Drugs on Mood and Performance
- ClinicalTrials.gov ID
- NCT02033707
- Acronym / sponsor ID
- NA_00082804
- Conditions
- Healthy
- Keywords
- Hallucinogen, Cognitive effects, Subjective effects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male volunteers | Experimental | Drug: Hallucinogens and psychoactive substancesHallucinogens and psychoactive substances will be administered via capsule. Results will be compared between male and female participants. |
| Female volunteers | Experimental | Drug: Hallucinogens and psychoactive substancesHallucinogens and psychoactive substances will be administered via capsule. Results will be compared between male and female participants. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hallucinogens and psychoactive substancesAlso: Hallucinogens, Sedatives & anxiolytics, Antihistamines, StimulantsOne 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. | Drug | Female volunteers, Male volunteers |
Primary outcome
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
1 secondary outcome
Hallucinogen Rating Scale
Time frame: Completed at the end of the experimental session (approximately 8 hours after capsule administration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Derived from this study: PubMed 38152462Mathai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland R Griffiths, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hallucinogens and psychoactive substances in people with Healthy, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02033707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.