Trial · NCT04315181

Prescription Medication Interactions

NCT04315181, Phase 1, Completed, Sharon Walsh; results first posted 2024-06-27

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Prescription Medication Interactions. Trials, record NCT04315181. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04315181

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Prescription Medication Interactions
NCT number: NCT04315181
Status: Completed
Phases: Phase 1
Enrollment: 11 participants, actual
Lead sponsor: Sharon Walsh
Conditions: Opioid Use, Sedative Use
Interventions: Opioid Agonist, Sedatives
First posted: 2020-03-19
Last updated: 2025-10-20
Results first posted: 2024-06-27

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking	This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).	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.
Secondary	Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect	This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).	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.
Secondary	Change in Respiration Rate	Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).	Respiration rate (number of breaths per minute). Raw data transformed to trough scores. Lower scores indicate greater impairment.
Secondary	Change in End-tidal Carbon Dioxide (EtCO2)	EtCO2 recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).	EtCO2 collected via capnograph monitored throughout each session. Raw data transformed to peak scores. Higher scores indicate greater impairment.
Secondary	Change in Oxygen Saturation	Oxygen saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).	Oxygen saturation (measured as a percentage through pulse ox) monitored throughout each session. Raw data transformed to trough scores. Lower scores indicate greater impairment.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking	This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).	Per Protocol population, defined as participants completing the 9 experimental drug conditions.	Score on a scale	MEAN
SECONDARY	Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect	This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).	Per Protocol population, defined as participants completing the 9 experimental drug conditions.	Score on a scale	MEAN
SECONDARY	Change in Respiration Rate	Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).	Per Protocol population, defined as participants completing the 9 experimental drug conditions.	Number of breaths per minute	MEAN
SECONDARY	Change in End-tidal Carbon Dioxide (EtCO2)	EtCO2 recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).	Per Protocol population, defined as participants completing the 9 experimental drug conditions.	mm Hg (unit of pressure)	MEAN
SECONDARY	Change in Oxygen Saturation	Oxygen saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).	Per Protocol population, defined as participants completing the 9 experimental drug conditions.	Percentage of oxygen in blood	MEAN

Source ClinicalTrials.gov

Results by group45

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking	Placebo / Placebo	7.40	Standard Error 2.39	Score on a scale
Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking	Placebo / Oxycodone 20mg	39.00	Standard Error 7.19	Score on a scale
Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking	Placebo / Oxycodone 40mg	40.80	Standard Error 9.14	Score on a scale
Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking	Gabapentin 600mg / Placebo	24.50	Standard Error 8.54	Score on a scale
Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking	Gabapentin 1200mg / Placebo	15.00	Standard Error 8.70	Score on a scale
Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking	Gabapentin 600mg / Oxycodone 20mg	40.70	Standard Error 9.10	Score on a scale
Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking	Gabapentin 1200mg / Oxycodone 20mg	34.50	Standard Error 8.26	Score on a scale
Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking	Gabapentin 600mg / Oxycodone 40mg	56.50	Standard Error 6.85	Score on a scale
Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking	Gabapentin 1200mg / Oxycodone 40mg	44.90	Standard Error 8.29	Score on a scale
Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect	Placebo / Placebo	10.70	Standard Error 2.94	Score on a scale

1 to 10 of 45Source ClinicalTrials.gov

See all 45 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Prescription Medication Interactions	11
Overall Study	Placebo/Placebo	Prescription Medication Interactions	10
Overall Study	Placebo / Oxycodone 20mg	Prescription Medication Interactions	10
Overall Study	Placebo / Oxycodone 40mg	Prescription Medication Interactions	10
Overall Study	Gabapentin 600mg / Placebo	Prescription Medication Interactions	10
Overall Study	Gabapentin 1200mg / Placebo	Prescription Medication Interactions	10
Overall Study	Gabapentin 600mg / Oxycodone 20mg	Prescription Medication Interactions	10
Overall Study	Gabapentin 1200mg / Oxycodone 20mg	Prescription Medication Interactions	10
Overall Study	Gabapentin 600mg / Oxycodone 40mg	Prescription Medication Interactions	10
Overall Study	Gabapentin 1200mg / Oxycodone 40mg	Prescription Medication Interactions	10

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events88

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Stomachache / upset stomach	Gastrointestinal disorders	Pre-Intervention / Days Off	0	11	0
other	Stomachache / upset stomach	Gastrointestinal disorders	Qualification: Placebo / Oxycodone 30mg	1	11	1
other	Stomachache / upset stomach	Gastrointestinal disorders	Placebo / Placebo	0	11	0
other	Stomachache / upset stomach	Gastrointestinal disorders	Placebo / Oxycodone 20mg	1	11	1
other	Stomachache / upset stomach	Gastrointestinal disorders	Placebo / Oxycodone 40mg	0	11	0
other	Stomachache / upset stomach	Gastrointestinal disorders	Gabapentin 600mg / Placebo	0	11	0
other	Stomachache / upset stomach	Gastrointestinal disorders	Gabapentin 1200mg / Placebo	0	11	0
other	Stomachache / upset stomach	Gastrointestinal disorders	Gabapentin 600mg / Oxycodone 20mg	0	11	0
other	Stomachache / upset stomach	Gastrointestinal disorders	Gabapentin 1200mg / Oxycodone 20mg	0	11	0
other	Stomachache / upset stomach	Gastrointestinal disorders	Gabapentin 600mg / Oxycodone 40mg	0	11	0

1 to 10 of 88Source ClinicalTrials.gov

See all 88 adverse events

Adverse event totals33

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Pre-Intervention / Days Off	11
Total, all-cause mortality	Qualification: Placebo / Oxycodone 30mg	11
Total, all-cause mortality	Placebo / Placebo	11
Total, all-cause mortality	Placebo / Oxycodone 20mg	11
Total, all-cause mortality	Placebo / Oxycodone 40mg	11
Total, all-cause mortality	Gabapentin 600mg / Placebo	11
Total, all-cause mortality	Gabapentin 1200mg / Placebo	11
Total, all-cause mortality	Gabapentin 600mg / Oxycodone 20mg	11
Total, all-cause mortality	Gabapentin 1200mg / Oxycodone 20mg	11
Total, all-cause mortality	Gabapentin 600mg / Oxycodone 40mg	11

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DA016718	Licit and Illicit Opioids: Comparative Studies in Humans	WALSH, SHARON L.	UNIVERSITY OF KENTUCKY	NATIONAL INSTITUTE ON DRUG ABUSE	2004 to 2023

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04315181

GET https://conductscience.org/api/trials/v1/NCT04315181/results?page=2

API reference For AI assistants