Trial · NCT03205423
Medication Development for Opioid and Alcohol Abuse
NCT03205423, Phase 2, Completed, New York State Psychiatric Institute; results first posted 2022-10-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Medication Development for Opioid and Alcohol Abuse. Trials, record NCT03205423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03205423
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Medication Development for Opioid and Alcohol Abuse
- NCT number
- NCT03205423
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- New York State Psychiatric Institute
- Conditions
- Opioid-use Disorder, Alcohol Use Disorder
- Interventions
- Gabapentin
- First posted
- 2017-07-02
- Last updated
- 2024-09-19
- Results first posted
- 2022-10-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Peak Positive Subjective Responses to Placebo. | Assessed every 15 minutes following drug administration,for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session. | Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely |
| Primary | Peak Positive Subjective Responses to Oxycodone (30mg) + Low Alcohol Dose. | Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session. | Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely |
| Primary | Peak Positive Subjective Responses to Oxycodone (30mg) + High Alcohol Dose. | Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session. | Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely |
| Primary | Peak Positive Subjective Responses to Oxycodone (15mg) + High Alcohol Dose. | Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session. | Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely |
| Primary | Peak Positive Subjective Responses to Oxycodone (15mg) + Low Alcohol Dose. | Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session. | Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely |
| Primary | Peak Positive Subjective Responses to Low Alcohol Dose. | Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session. | Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely |
| Primary | Peak Positive Subjective Responses to High Alcohol Dose. | Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session. | Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely |
| Primary | Peak Positive Subjective Responses to Oxycodone (30mg) | Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session. | Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely |
| Primary | Peak Positive Subjective Responses to Oxycodone (15mg) | Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session. | Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Peak Positive Subjective Responses to Placebo. | Assessed every 15 minutes following drug administration,for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session. | Participants who completed both the active and placebo gabapentin maintenance phases of the trial. | units on a scale | MEAN |
| PRIMARY | Peak Positive Subjective Responses to Oxycodone (30mg) + Low Alcohol Dose. | Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session. | Participants who completed both the active and placebo phases of the trial. | units on a scale | MEAN |
| PRIMARY | Peak Positive Subjective Responses to Oxycodone (30mg) + High Alcohol Dose. | Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session. | Participants who completed both the active and placebo gabapentin maintenance phases of the trial. | units on a scale | MEAN |
| PRIMARY | Peak Positive Subjective Responses to Oxycodone (15mg) + High Alcohol Dose. | Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session. | Participants who completed both the active and placebo gabapentin maintenance phases of the trial. | units on a scale | MEAN |
| PRIMARY | Peak Positive Subjective Responses to Oxycodone (15mg) + Low Alcohol Dose. | Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session. | Participants who completed both the active and placebo gabapentin maintenance phases of the trial. | units on a scale | MEAN |
| PRIMARY | Peak Positive Subjective Responses to Low Alcohol Dose. | Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session. | Participants who completed both the active and placebo gabapentin maintenance phases of the trial. | units on a scale | MEAN |
| PRIMARY | Peak Positive Subjective Responses to High Alcohol Dose. | Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session. | Participants who completed both the active and placebo gabapentin maintenance phases of the trial. | units on a scale | MEAN |
| PRIMARY | Peak Positive Subjective Responses to Oxycodone (30mg) | Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session. | Participants who completed both the active and placebo gabapentin maintenance phases of the trial. | units on a scale | MEAN |
| PRIMARY | Peak Positive Subjective Responses to Oxycodone (15mg) | Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session. | Participants who completed both the active and placebo gabapentin maintenance phases of the trial. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Peak Positive Subjective Responses to Placebo. | Gabapentin 0 mg | 3.3 | Standard Deviation .8 | units on a scale | |
| Peak Positive Subjective Responses to Placebo. | Gabapentin 1800 mg | 2.3 | Standard Deviation .6 | units on a scale | |
| Peak Positive Subjective Responses to Oxycodone (30mg) + Low Alcohol Dose. | Gabapentin 0 mg | 3.0 | Standard Deviation .6 | units on a scale | |
| Peak Positive Subjective Responses to Oxycodone (30mg) + Low Alcohol Dose. | Gabapentin 1800 mg | 9.1 | Standard Deviation 1.2 | units on a scale | |
| Peak Positive Subjective Responses to Oxycodone (30mg) + High Alcohol Dose. | Gabapentin 0 mg | 6.7 | Standard Deviation 1.1 | units on a scale | |
| Peak Positive Subjective Responses to Oxycodone (30mg) + High Alcohol Dose. | Gabapentin 1800 mg | 10.9 | Standard Deviation 1.3 | units on a scale | |
| Peak Positive Subjective Responses to Oxycodone (15mg) + High Alcohol Dose. | Gabapentin 0 mg | 6.3 | Standard Deviation .9 | units on a scale | |
| Peak Positive Subjective Responses to Oxycodone (15mg) + High Alcohol Dose. | Gabapentin 1800 mg | 9.7 | Standard Deviation 1.3 | units on a scale | |
| Peak Positive Subjective Responses to Oxycodone (15mg) + Low Alcohol Dose. | Gabapentin 0 mg | 3.7 | Standard Deviation .6 | units on a scale | |
| Peak Positive Subjective Responses to Oxycodone (15mg) + Low Alcohol Dose. | Gabapentin 1800 | 8.0 | Standard Deviation 1.1 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gabapentin (Active First) | 8 | |
| Overall Study | STARTED | Gabapentin (Placebo First) | 9 | |
| Overall Study | COMPLETED | Gabapentin (Active First) | 7 | |
| Overall Study | COMPLETED | Gabapentin (Placebo First) | 6 | |
| Overall Study | NOT COMPLETED | Gabapentin (Active First) | 1 | |
| Overall Study | NOT COMPLETED | Gabapentin (Placebo First) | 3 |
Source ClinicalTrials.gov
Adverse events2
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 | Elevated Blood Pressure | Cardiac disorders | Gabapentin (0 mg, i.e., Placebo) | 1 | 17 | 1 |
| other | Elevated Blood Pressure | Cardiac disorders | Gabapentin (1800 mg i.e., Active) | 1 | 17 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gabapentin (0 mg, i.e., Placebo) | 0 | 17 |
| Total, all-cause mortality | Gabapentin (1800 mg i.e., Active) | 0 | 17 |
| Total, other adverse events | Gabapentin (0 mg, i.e., Placebo) | 1 | 17 |
| Total, other adverse events | Gabapentin (1800 mg i.e., Active) | 1 | 17 |
| Total, serious adverse events | Gabapentin (0 mg, i.e., Placebo) | 0 | 17 |
| Total, serious adverse events | Gabapentin (1800 mg i.e., Active) | 0 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38126709 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gabapentin (1800 mg i.e., Active) vs Gabapentin (0 mg, i.e., Placebo): deaths from any cause | Trial comparisons |
| Gabapentin (1800 mg i.e., Active) vs Gabapentin (0 mg, i.e., Placebo): serious adverse events | Trial comparisons |
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT03205423
GET https://conductscience.org/api/trials/v1/NCT03205423/registered