Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2025-11-15
2027-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Experimental Session 1
This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.
Blinded Study Medication - Condition 1
Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.
Experimental Session 2
This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.
Blinded Study Medication - Condition 2
Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.
Experimental Session 3
This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.
Blinded Study Medication - Condition 3
Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.
Experimental Session 4
This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.
Blinded Study Medication - Condition 4
Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.
Experimental Session 5
This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.
Blinded Study Medication - Condition 5
Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.
Experimental Session 6
This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.
Placebo
Double blind administration of placebo.
Interventions
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Blinded Study Medication - Condition 1
Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.
Blinded Study Medication - Condition 2
Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.
Blinded Study Medication - Condition 3
Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.
Blinded Study Medication - Condition 4
Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.
Blinded Study Medication - Condition 5
Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.
Placebo
Double blind administration of placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Vital signs in normal range as reviewed by study medical team
3. Person is willing and able to provide informed consent
Exclusion Criteria
2. Seeking treatment for alcohol or substance use
3. Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity
4. Active hepatic disease or abnormal liver function tests
5. Current major depressive disorder or suicidality
6. Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding. People of childbearing potential will be asked to ensure, and/or the partner use effective forms of contraception for the duration of the study and excluded if unable.
7. Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.
8. Contraindications or allergies to study medications
9. Evidence of recent illicit substance use (i.e., positive urinalysis) at screening for drugs other than cannabis
10. Seizure disorder or traumatic brain injury (TBI)
11. Taking medications known to interact with study medications
18 Years
55 Years
ALL
Yes
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Justin Stricklahd, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Behavioral Pharmacology Research Unit, Baltimore
Baltimore, Maryland, United States
Countries
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Other Identifiers
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IRB00454735
Identifier Type: -
Identifier Source: org_study_id