Healthy Volunteers
Conditions
Brief summary
This research is being done to evaluate the impact of various drugs and combinations of drugs on mood, pain, and performance.
Detailed description
This research is being done to evaluate the impact of various drugs and combinations of drugs on mood, pain, and performance. Participants will complete 1 screening visit and 7 study test sessions. During the study sessions the participant will receive a study drug that may contain blinded drugs or drug combinations. Participants will answer questions about how the participant feels, perform tasks that measure the participant's cognitive ability and experience of pain, and have heart rate and blood pressure measured. While not at the laboratory, participants will be asked to wear a wristwatch that measures sleep and activity and complete questions about sleep.
Interventions
DRUGBlinded 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.
DRUGBlinded 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.
DRUGBlinded 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.
DRUGBlinded 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.
DRUGBlinded 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.
DRUGPlacebo
Double blind administration of placebo.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
This study will use a fully within subjects design (i.e., all subjects were to receive all drug combination conditions in a latin-square randomized order).
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18-55 years 2. Vital signs in normal range as reviewed by study medical team 3. Person is willing and able to provide informed consent
Exclusion criteria
1. Evidence of physical dependence on alcohol or benzodiazepines based on tolerance and withdrawal upon cessation of use of alcohol or benzodiazepines reported in the Mini-International Neuropsychiatric Interview (MINI) as well as clinical interviews by medical staff during H&P. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demand Intensity - Consumption of Blinded Drug at Unconstrained Price as Measured by a Demand Task | Upon completion of experimental session (~8 hours post drug administration) | Consumption of blinded drug at unconstrained price as measured by a demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more drug consumption at unconstrained price (a worse outcome). |
| Breakpoint - Maximum price paid for blinded drug as measured by a demand task | Upon completion of experimental session (~8 hours post drug administration) | Maximum price paid for blinded drug as measured by a demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate higher price paid (a worse outcome). |
| Cold Pressor Pain - Seconds to withdraw hand from cold pressor | Baseline and 1, 2, 4, and 6 hours post drug administration | Seconds to withdraw hand from cold pressor laboratory pain task, where longer time periods reflect higher tolerance to pain. |
| Cognitive Performance assessed by Digit Symbol Substitution Test (DSST) | Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, and 8 hours post drug administration. | Within-subject comparison of study conditions on the Digit Symbol Substitution Test (DSST), a measure of cognitive performance that is sensitive to drug effects, wherein lower percent scores reflect worse performance and suggest greater drug-related impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug Liking assessed by Visual Analog Scale of Drug Liking | Upon completion of experimental session (~9 hours post drug administration) | Ratings on a visual analog scale of drug liking. Minimum value is 0 and maximum value is 100. Higher scores indicate greater drug liking (a worse outcome). |
Countries
United States
Outcome results
None listed