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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA058138-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The primary objective of this study is to determine if increasing age confers greater vulnerability to the acute A) cognitive (e.g., memory, attention, psychomotor function), B) subjective (e.g., anxiogenic and rewarding effects), and C) cardiovascular (heart rate and blood pressure), effects of THC in adults > 21 years old. The secondary aims of the study are to explore age-related acute effects of THC on electrophysiological indices of information processing (e.g., auditory steady-state response (ASSR), oddball paradigm [P300], and resting state cortical noise) and to determine age-related differences in the metabolism of THC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delta-9-THC Very Low Dose | Active Comparator | Active delta-9-THC administered intravenously over 20 minutes. |
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| Placebo | Placebo Comparator | Control: Small amount of alcohol administered intravenously (quarter teaspoon), with no delta-9-THC, over 20 minutes. |
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| Delta-9-THC Medium Dose | Active Comparator | Active delta-9-THC administered intravenously over 20 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delta-9-THC Low Dose | Drug | Active Delta-9-THC administered intravenously over 20 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rey Auditory Verbal Learning Task (RAVLT) total immediate recall | The task consists of 5 trials, an interference list, free delayed recall, and recognition. | Each test day will be split into two drug administration sessions. The RAVLT will be administered approximately 25 minutes after each drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | Various feeling states will be measured using a self-reported visual analog scale of feeling states (ex: "calm and relaxed", and "tired") associated with drug administration. Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 100 mm line (0 = not at all, 100 = extremely). A higher score reflects a positive response. | -60 minutes, 20 minutes, 60 minutes, 120 minutes, 170 minutes, 210 minutes, 270 minutes, 300 minutes, 360 minutes, 420 minutes after the start of the initial THC/placebo drug infusion. |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deepak C D'Souza | Contact | 203-932-5711 | 12594 | deepak.douza@yale.edu |
| Ashley Schnakenberg Martin, PhD | Contact | ashley.martin@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Deepak C D'Souza, MD | Yale University School of Medicine; VA Connecticut Healthcare System | Principal Investigator |
| Ashley Schnakenberg Martin, PhD | Yale University School of Medicine; VA Connecticut Healthcare System |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System | Recruiting | West Haven | Connecticut | 06516 | United States |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Small amount of sterile ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes. |
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| Delta-9-THC Medium Dose | Drug | Active Delta-9-THC administered intravenously over 20 minutes |
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