Trial Outcomes & Findings for Prescription Medication Interactions (NCT NCT04315181)
NCT ID: NCT04315181
Last Updated: 2025-10-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Results posted on
2025-10-20
Participant Flow
This is a crossover study with 9 conditions tested in random order in each completing subject.
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
Placebo/Placebo
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10
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Overall Study
Placebo / Oxycodone 20mg
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10
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Overall Study
Placebo / Oxycodone 40mg
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10
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Overall Study
Gabapentin 600mg / Placebo
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10
|
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Overall Study
Gabapentin 1200mg / Placebo
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10
|
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Overall Study
Gabapentin 600mg / Oxycodone 20mg
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10
|
|
Overall Study
Gabapentin 1200mg / Oxycodone 20mg
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10
|
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Overall Study
Gabapentin 600mg / Oxycodone 40mg
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10
|
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Overall Study
Gabapentin 1200mg / Oxycodone 40mg
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10
|
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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
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|---|---|
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Overall Study
Non-responsive to drug conditions.
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1
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Baseline Characteristics
Prescription Medication Interactions
Baseline characteristics by cohort
| Measure |
Completing Participants
n=10 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
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|---|---|
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Age, Continuous
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36.80 years
STANDARD_DEVIATION 8.11 • n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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2 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
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6 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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10 participants
n=5 Participants
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PRIMARY outcome
Timeframe: This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).Population: Per Protocol population, defined as participants completing the 9 experimental drug conditions.
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.
Outcome measures
| Measure |
Placebo / Placebo
n=10 Participants
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 20mg
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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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Gabapentin 600mg / Oxycodone 20mg
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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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Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking
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7.40 Score on a scale
Standard Error 2.39
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39.00 Score on a scale
Standard Error 7.19
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40.80 Score on a scale
Standard Error 9.14
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24.50 Score on a scale
Standard Error 8.54
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15.00 Score on a scale
Standard Error 8.70
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40.70 Score on a scale
Standard Error 9.10
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34.50 Score on a scale
Standard Error 8.26
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56.50 Score on a scale
Standard Error 6.85
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44.90 Score on a scale
Standard Error 8.29
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SECONDARY outcome
Timeframe: This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).Population: Per Protocol population, defined as participants completing the 9 experimental drug conditions.
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.
Outcome measures
| Measure |
Placebo / Placebo
n=10 Participants
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 20mg
n=10 Participants
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
n=10 Participants
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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Gabapentin 600mg / Placebo
n=10 Participants
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
n=10 Participants
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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Gabapentin 600mg / Oxycodone 20mg
n=10 Participants
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
n=10 Participants
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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Gabapentin 600mg / Oxycodone 40mg
n=10 Participants
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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Gabapentin 1200mg / Oxycodone 40mg
n=10 Participants
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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Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect
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10.70 Score on a scale
Standard Error 2.94
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39.30 Score on a scale
Standard Error 6.32
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39.70 Score on a scale
Standard Error 8.05
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25.00 Score on a scale
Standard Error 7.43
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21.50 Score on a scale
Standard Error 9.93
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39.10 Score on a scale
Standard Error 7.37
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37.50 Score on a scale
Standard Error 7.73
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52.30 Score on a scale
Standard Error 8.36
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44.40 Score on a scale
Standard Error 8.51
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SECONDARY outcome
Timeframe: Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).Population: Per Protocol population, defined as participants completing the 9 experimental drug conditions.
Respiration rate (number of breaths per minute). Raw data transformed to trough scores. Lower scores indicate greater impairment.
Outcome measures
| Measure |
Placebo / Placebo
n=10 Participants
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 20mg
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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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|---|---|---|---|---|---|---|---|---|---|
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Change in Respiration Rate
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12.70 Number of breaths per minute
Standard Error 0.68
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12.00 Number of breaths per minute
Standard Error 0.42
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11.50 Number of breaths per minute
Standard Error 0.54
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12.10 Number of breaths per minute
Standard Error 0.41
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12.90 Number of breaths per minute
Standard Error 0.66
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11.80 Number of breaths per minute
Standard Error 0.51
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12.10 Number of breaths per minute
Standard Error 0.59
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11.30 Number of breaths per minute
Standard Error 0.47
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11.90 Number of breaths per minute
Standard Error 0.57
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SECONDARY outcome
Timeframe: EtCO2 recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).Population: Per Protocol population, defined as participants completing the 9 experimental drug conditions.
EtCO2 collected via capnograph monitored throughout each session. Raw data transformed to peak scores. Higher scores indicate greater impairment.
Outcome measures
| Measure |
Placebo / Placebo
n=10 Participants
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 20mg
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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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|---|---|---|---|---|---|---|---|---|---|
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Change in End-tidal Carbon Dioxide (EtCO2)
|
39.60 mm Hg (unit of pressure)
Standard Error 1.01
|
41.20 mm Hg (unit of pressure)
Standard Error 0.87
|
42.90 mm Hg (unit of pressure)
Standard Error 1.08
|
39.10 mm Hg (unit of pressure)
Standard Error 0.64
|
38.40 mm Hg (unit of pressure)
Standard Error 0.48
|
42.00 mm Hg (unit of pressure)
Standard Error 0.75
|
41.90 mm Hg (unit of pressure)
Standard Error 0.59
|
44.80 mm Hg (unit of pressure)
Standard Error 0.68
|
43.90 mm Hg (unit of pressure)
Standard Error 0.90
|
SECONDARY outcome
Timeframe: Oxygen saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).Population: Per Protocol population, defined as participants completing the 9 experimental drug conditions.
Oxygen saturation (measured as a percentage through pulse ox) monitored throughout each session. Raw data transformed to trough scores. Lower scores indicate greater impairment.
Outcome measures
| Measure |
Placebo / Placebo
n=10 Participants
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 20mg
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Oxygen Saturation
|
96.77 Percentage of oxygen in blood
Standard Error 0.40
|
96.29 Percentage of oxygen in blood
Standard Error 0.25
|
95.72 Percentage of oxygen in blood
Standard Error 0.53
|
96.86 Percentage of oxygen in blood
Standard Error 0.58
|
96.87 Percentage of oxygen in blood
Standard Error 0.32
|
96.59 Percentage of oxygen in blood
Standard Error 0.19
|
96.29 Percentage of oxygen in blood
Standard Error 0.28
|
95.80 Percentage of oxygen in blood
Standard Error 0.45
|
95.61 Percentage of oxygen in blood
Standard Error 0.41
|
Adverse Events
Pre-Intervention / Days Off
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Qualification: Placebo / Oxycodone 30mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo / Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo / Oxycodone 20mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo / Oxycodone 40mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gabapentin 600mg / Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Gabapentin 1200mg / Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gabapentin 600mg / Oxycodone 20mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gabapentin 1200mg / Oxycodone 20mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gabapentin 600mg / Oxycodone 40mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Gabapentin 1200mg / Oxycodone 40mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pre-Intervention / Days Off
n=11 participants at risk
Prior to any drug administration or on participant days off when AE is not related to drug conditions.
|
Qualification: Placebo / Oxycodone 30mg
n=11 participants at risk
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.
|
Placebo / Placebo
n=11 participants at risk
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.
|
Placebo / Oxycodone 20mg
n=11 participants at risk
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.
|
Placebo / Oxycodone 40mg
n=11 participants at risk
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.
|
Gabapentin 600mg / Placebo
n=11 participants at risk
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.
|
Gabapentin 1200mg / Placebo
n=11 participants at risk
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.
|
Gabapentin 600mg / Oxycodone 20mg
n=11 participants at risk
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.
|
Gabapentin 1200mg / Oxycodone 20mg
n=11 participants at risk
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.
|
Gabapentin 600mg / Oxycodone 40mg
n=11 participants at risk
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.
|
Gabapentin 1200mg / Oxycodone 40mg
n=11 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Toothache
|
18.2%
2/11 • Number of events 2 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
|
Skin and subcutaneous tissue disorders
Itching Feet
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
|
Gastrointestinal disorders
Stomachache / upset stomach
|
0.00%
0/11 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
|
Gastrointestinal disorders
Nausea / vomiting
|
0.00%
0/11 • 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.
|
27.3%
3/11 • Number of events 3 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/11 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
|
Musculoskeletal and connective tissue disorders
Cramping
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • Number of events 3 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
|
Musculoskeletal and connective tissue disorders
Tightness/swollen neck
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/11 • 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.
|
Additional Information
Director for the Center on Drug and Alcohol Research
University of Kentucky
Phone: 859-257-6485
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place