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The lead investigator moved institutions and the study will not continue upon his departure.
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This research is being done to evaluate the impact of various drugs and combinations of drugs on mood, pain, and performance.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Session 1 | Experimental | This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order. |
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| Experimental Session 2 | Experimental | This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order. |
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| Experimental Session 3 | Experimental | This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order. |
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| Experimental Session 4 | Experimental | This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order. |
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| Experimental Session 5 | Experimental | This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blinded Study Medication - Condition 1 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Demand Intensity - Consumption of Blinded Drug at Unconstrained Price as Measured by a Demand Task | 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). | Upon completion of experimental session (~8 hours post drug administration) |
| Breakpoint - Maximum price paid for blinded drug as measured by a demand task | 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). | Upon completion of experimental session (~8 hours post drug administration) |
| Cold Pressor Pain - Seconds to withdraw hand from cold pressor | Seconds to withdraw hand from cold pressor laboratory pain task, where longer time periods reflect higher tolerance to pain. | Baseline and 1, 2, 4, and 6 hours post drug administration |
| Cognitive Performance assessed by Digit Symbol Substitution Test (DSST) | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Liking assessed by Visual Analog Scale of Drug Liking | 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). | Upon completion of experimental session (~9 hours post drug administration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Stricklahd, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Pharmacology Research Unit, Baltimore | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D000697 | Central Nervous System Stimulants |
| D002186 | Cannabinoids |
| D001569 | Benzodiazepines |
| D000701 | Analgesics, Opioid |
| D004366 | Nonprescription Drugs |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
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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).
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| Experimental Session 6 | Experimental | This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order. |
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| Blinded Study Medication - Condition 2 | Drug | 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. |
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| Blinded Study Medication - Condition 3 | Drug | 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. |
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| Blinded Study Medication - Condition 4 | Drug | 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. |
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| Blinded Study Medication - Condition 5 | Drug | 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. |
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| Placebo | Drug | Double blind administration of placebo. |
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| D045506 | Therapeutic Uses |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |