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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA016718 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will examine the effects of doses of opioid/placebo and doses of sedative/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.
Gabapentin and oxycodone are commonly used in combination for the treatment of chronic pain. Gabapentin is now widely misused/abused with studies indicating that gabapentin abuse is especially common among individuals with opioid misuse. The nature of gabapentin's abuse-related effects have been described in case reports and online as sedative-like and opioid-like, with descriptive reports including sedation, euphoria, talkativeness and increased energy. Despite their widespread co-administration both for licit and illicit purposes, no controlled psychopharmacological studies to our knowledge have directly examined the effects of oxycodone (or another opioid agonist) and gabapentin in combination. This study's objective is to characterize the subjective effect profile of gabapentin, examine the interaction between gabapentin and oxycodone, and assess the acute analgesic response to gabapentin and oxycodone, alone and in combination, across a range of doses for each drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo / Placebo | Placebo Comparator | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
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| Placebo / Oxycodone 20mg | Experimental | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
|
| Placebo / Oxycodone 40mg | Experimental | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
|
| Gabapentin 600mg / Placebo | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid Agonist | Drug | Abuse liability evaluation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Raw data transformed to peak scores. Higher scores indicate greater drug effects. | This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect | Participants rated their subjective drug effect on a standardized VAS scale (0 to 100). Raw data transformed to peak scores. Higher scores indicate greater drug effects. | This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon L Walsh, Ph.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center on Drug and Alcohol Research | Lexington | Kentucky | 40508 | United States |
We have no plans to share individual participant data with other researchers.
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This is a crossover study with 9 conditions tested in random order in each completing subject.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prescription Medication Interactions | Within subject study. Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. Opioid Agonist: Active opioid agonist or placebo, administered orally Sedatives: Active sedative or placebo, administered orally |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One participant did not complete the study. They were non-responsive to the drug conditions and was discharged.
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| ID | Title | Description |
|---|---|---|
| BG000 | Completing Participants | Subjects who completed the full study (i.e., completed all dose conditions) Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. Opioid Agonist: Active opioid agonist or placebo, administered orally Sedatives: Active sedative or placebo, administered orally |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Raw data transformed to peak scores. Higher scores indicate greater drug effects. | Per Protocol population, defined as participants completing the 9 experimental drug conditions. | Posted | Mean | Standard Error | Score on a scale | This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). |
|
Approximately 6 weeks. AE monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit.
Adverse event definitions are the same as the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-Intervention / Days Off | Prior to any drug administration or on participant days off when AE is not related to drug conditions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomachache / upset stomach | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director for the Center on Drug and Alcohol Research | University of Kentucky | 859-257-6485 | Sharon.Walsh@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 8, 2024 | May 2, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 18, 2023 | May 3, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 18, 2023 | Jan 17, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000701 | Analgesics, Opioid |
| D006993 | Hypnotics and Sedatives |
| ID | Term |
|---|---|
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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This is a randomized, double-blind, double-dummy, placebo- controlled design
Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.
|
| Gabapentin 1200mg / Placebo | Experimental | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
|
| Gabapentin 600mg / Oxycodone 20mg | Experimental | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
|
| Gabapentin 1200mg / Oxycodone 20mg | Experimental | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
|
| Gabapentin 600mg / Oxycodone 40mg | Experimental | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
|
| Gabapentin 1200mg / Oxycodone 40mg | Experimental | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
|
| Sedatives | Drug | Abuse liability evaluation. |
|
| Change in Respiration Rate | Respiration rate (number of breaths per minute). Raw data transformed to trough scores. Lower scores indicate greater impairment. | Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). |
| Change in End-tidal Carbon Dioxide (EtCO2) | EtCO2 collected via capnograph monitored throughout each session. Raw data transformed to peak scores. Higher scores indicate greater impairment. | EtCO2 recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). |
| Change in Oxygen Saturation | Oxygen saturation (measured as a percentage through pulse ox) monitored throughout each session. Raw data transformed to trough scores. Lower scores indicate greater impairment. | Oxygen saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Placebo / Oxycodone 20mg | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
| OG002 | Placebo / Oxycodone 40mg | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
| OG003 | Gabapentin 600mg / Placebo | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
| OG004 | Gabapentin 1200mg / Placebo | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
| OG005 | Gabapentin 600mg / Oxycodone 20mg | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
| OG006 | Gabapentin 1200mg / Oxycodone 20mg | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
| OG007 | Gabapentin 600mg / Oxycodone 40mg | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
| OG008 | Gabapentin 1200mg / Oxycodone 40mg | Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. |
|
|
|
| Secondary | Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect | Participants rated their subjective drug effect on a standardized VAS scale (0 to 100). Raw data transformed to peak scores. Higher scores indicate greater drug effects. | Per Protocol population, defined as participants completing the 9 experimental drug conditions. | Posted | Mean | Standard Error | Score on a scale | This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). |
|
|
|
|
| Secondary | Change in Respiration Rate | Respiration rate (number of breaths per minute). Raw data transformed to trough scores. Lower scores indicate greater impairment. | Per Protocol population, defined as participants completing the 9 experimental drug conditions. | Posted | Mean | Standard Error | Number of breaths per minute | Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). |
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|
|
| Secondary | Change in End-tidal Carbon Dioxide (EtCO2) | EtCO2 collected via capnograph monitored throughout each session. Raw data transformed to peak scores. Higher scores indicate greater impairment. | Per Protocol population, defined as participants completing the 9 experimental drug conditions. | Posted | Mean | Standard Error | mm Hg (unit of pressure) | EtCO2 recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). |
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|
|
| Secondary | Change in Oxygen Saturation | Oxygen saturation (measured as a percentage through pulse ox) monitored throughout each session. Raw data transformed to trough scores. Lower scores indicate greater impairment. | Per Protocol population, defined as participants completing the 9 experimental drug conditions. | Posted | Mean | Standard Error | Percentage of oxygen in blood | Oxygen saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). |
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|
| 0 |
| 11 |
| 0 |
| 11 |
| 5 |
| 11 |
| EG001 | Qualification: Placebo / Oxycodone 30mg | Prior to the experimental conditions, participants will receive non-therapeutic doses of gabapentin 0 mg, p.o., with oxycodone 30 mg, p.o. during a qualifying day session. This session serves as a responsive challenge which is intended to confirm that subjects are able to detect the active drug. | 0 | 11 | 0 | 11 | 5 | 11 |
| EG002 | Placebo / Placebo | Participants will receive non-therapeutic experimental doses of gabapentin (0, 600 and 1200 mg, p.o.), alone and in combination with oxycodone (0, 20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Placebo / Oxycodone 20mg | Participants will receive non-therapeutic experimental doses of gabapentin (0, 600 and 1200 mg, p.o.), alone and in combination with oxycodone (0, 20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG004 | Placebo / Oxycodone 40mg | Participants will receive non-therapeutic experimental doses of gabapentin (0, 600 and 1200 mg, p.o.), alone and in combination with oxycodone (0, 20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG005 | Gabapentin 600mg / Placebo | Participants will receive non-therapeutic experimental doses of gabapentin (0, 600 and 1200 mg, p.o.), alone and in combination with oxycodone (0, 20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG006 | Gabapentin 1200mg / Placebo | Participants will receive non-therapeutic experimental doses of gabapentin (0, 600 and 1200 mg, p.o.), alone and in combination with oxycodone (0, 20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG007 | Gabapentin 600mg / Oxycodone 20mg | Participants will receive non-therapeutic experimental doses of gabapentin (0, 600 and 1200 mg, p.o.), alone and in combination with oxycodone (0, 20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG008 | Gabapentin 1200mg / Oxycodone 20mg | Participants will receive non-therapeutic experimental doses of gabapentin (0, 600 and 1200 mg, p.o.), alone and in combination with oxycodone (0, 20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG009 | Gabapentin 600mg / Oxycodone 40mg | Participants will receive non-therapeutic experimental doses of gabapentin (0, 600 and 1200 mg, p.o.), alone and in combination with oxycodone (0, 20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG010 | Gabapentin 1200mg / Oxycodone 40mg | Participants will receive non-therapeutic experimental doses of gabapentin (0, 600 and 1200 mg, p.o.), alone and in combination with oxycodone (0, 20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. | 0 | 11 | 0 | 11 | 1 | 11 |
| Nausea / vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Itching Feet | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Toothache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tightness/swollen neck | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |