Trial · NCT03220776

Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics

NCT03220776, Phase 2, Completed, Medical University of South Carolina; results first posted 2023-12-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics. Trials, record NCT03220776. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03220776

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Trial

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

Title: Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics
NCT number: NCT03220776
Status: Completed
Phases: Phase 2
Enrollment: 54 participants, actual
Lead sponsor: Medical University of South Carolina
Conditions: Alcohol Use Disorder, Bipolar Disorder
Interventions: N-Acetylcysteine, Gabapentin, Placebo Oral Tablet
First posted: 2017-07-18
Last updated: 2023-12-13
Results first posted: 2023-12-13

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Prefrontal GABA+ Concentrations	Day 5 of each experimental condition	Concentrations of GABA+, referenced to unsuppressed water and corrected for within-voxel CSF proportion, in dorsal anterior cingulate cortex measured via Proton Magnetic Resonance Spectroscopy (i.e., MEGA-PRESS).
Primary	Prefrontal Glx Concentrations	Day 5 of each experimental condition	Concentrations of Glx (i.e., glutamate + glutamine), referenced to unsuppressed water and corrected for within-voxel CSF proportion, in dorsal anterior cingulate cortex measured via Proton Magnetic Resonance Spectroscopy.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Prefrontal GABA+ Concentrations	Day 5 of each experimental condition	Overall number of participants analyzed includes participants who completed the entire medication condition (i.e. participants who started N-Acetylcysteine, Gabapentin, or Placebo Oral Tablet but who did not complete the MRI portion of the condition have been removed from outcome measure data analysis, but are included in other portions of this study record \[Adverse Events, Demographics, etc.\]).	mmol/kg	MEAN
PRIMARY	Prefrontal Glx Concentrations	Day 5 of each experimental condition	Overall number of participants analyzed includes participants who completed the entire medication condition (i.e. participants who started N-Acetylcysteine, Gabapentin, or Placebo Oral Tablet but who did not complete the MRI portion of the condition have been removed from outcome measure data analysis, but are included in other portions of this study record \[Adverse Events, Demographics, etc.\]).	mmol/kg	MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Prefrontal GABA+ Concentrations	N-Acetylcysteine	3.90	Standard Deviation 0.543	mmol/kg
Prefrontal GABA+ Concentrations	Gabapentin	3.93	Standard Deviation 0.646	mmol/kg
Prefrontal GABA+ Concentrations	Placebo Oral Tablet	3.73	Standard Deviation 0.705	mmol/kg
Prefrontal Glx Concentrations	N-Acetylcysteine	21.59	Standard Deviation 2.518	mmol/kg
Prefrontal Glx Concentrations	Gabapentin	21.69	Standard Deviation 2.499	mmol/kg
Prefrontal Glx Concentrations	Placebo Oral Tablet	22.25	Standard Deviation 2.746	mmol/kg

Source ClinicalTrials.gov

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Gabapentin, Washout, Then N-Acetylcysteine, Washout, Then Placebo Oral Capsule, Washout	9
Overall Study	STARTED	N-Acetylcysteine, Washout, Then Placebo Oral Capsule, Washout, Then Gabapentin, Washout	9
Overall Study	STARTED	Placebo Oral Tablet, Washout, Then Gabapentin, Washout, Then N-Acetylcysteine, Washout	9
Overall Study	STARTED	Placebo Oral Capsule, Washout, Then N-Acetylcysteine, Washout, Then Gabapentin, Washout	9
Overall Study	STARTED	Gabapentin, Washout, Then Placebo Oral Capsule, Washout, Then N-Acetylcysteine, Washout	9
Overall Study	STARTED	N-Acetylcysteine, Washout, Then Gabapentin, Washout, Then Placebo Oral Capsule, Washout	9
Overall Study	COMPLETED	Gabapentin, Washout, Then N-Acetylcysteine, Washout, Then Placebo Oral Capsule, Washout	7
Overall Study	COMPLETED	N-Acetylcysteine, Washout, Then Placebo Oral Capsule, Washout, Then Gabapentin, Washout	8
Overall Study	COMPLETED	Placebo Oral Tablet, Washout, Then Gabapentin, Washout, Then N-Acetylcysteine, Washout	8
Overall Study	COMPLETED	Placebo Oral Capsule, Washout, Then N-Acetylcysteine, Washout, Then Gabapentin, Washout	5

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events63

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	insomnia	Psychiatric disorders	N-Acetylcysteine	0	48	0
other	insomnia	Psychiatric disorders	Gabapentin	1	48	1
other	insomnia	Psychiatric disorders	Placebo Oral Tablet	1	51	1
other	headache	Nervous system disorders	N-Acetylcysteine	2	48	2
other	headache	Nervous system disorders	Gabapentin	0	48	0
other	headache	Nervous system disorders	Placebo Oral Tablet	1	51	1
other	Dizziness	Nervous system disorders	N-Acetylcysteine	0	48	0
other	Dizziness	Nervous system disorders	Gabapentin	3	48	3
other	Dizziness	Nervous system disorders	Placebo Oral Tablet	2	51	2
other	Fatigue	General disorders	N-Acetylcysteine	3	48	3

1 to 10 of 63Source ClinicalTrials.gov

See all 63 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	N-Acetylcysteine	0	48
Total, all-cause mortality	Gabapentin	0	48
Total, all-cause mortality	Placebo Oral Tablet	0	51
Total, other adverse events	N-Acetylcysteine	10	48
Total, other adverse events	Gabapentin	9	48
Total, other adverse events	Placebo Oral Tablet	6	51
Total, serious adverse events	N-Acetylcysteine	0	48
Total, serious adverse events	Gabapentin	0	48
Total, serious adverse events	Placebo Oral Tablet	0	51

Source ClinicalTrials.gov

Papers162

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
444788	BACKGROUND	PubMed
728692	BACKGROUND	PubMed
2029805	BACKGROUND	PubMed
2232018	BACKGROUND	PubMed
2236451	BACKGROUND	PubMed
2597811	BACKGROUND	PubMed
2748771	BACKGROUND	PubMed
5146491	BACKGROUND	PubMed
6209989	BACKGROUND	PubMed
7573780	BACKGROUND	PubMed

1 to 10 of 162

See all 162 papers

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
R01AA025365	Imaging Framework for Testing GABAergic Drugs in Bipolar Alcoholics	PRISCIANDARO, JAMES JOSEPH	MEDICAL UNIVERSITY OF SOUTH CAROLINA	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2017 to 2022

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.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03220776

GET https://conductscience.org/api/trials/v1/NCT03220776/events?page=2

API reference For AI assistants