Trial · NCT04052139

St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin

NCT04052139, Phase 2, Completed, Boston Medical Center; results first posted 2022-11-10

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin. Trials, record NCT04052139. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04052139

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Trial

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

Title: St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin
NCT number: NCT04052139
Status: Completed
Phases: Phase 2
Enrollment: 45 participants, actual
Lead sponsor: Boston Medical Center
Conditions: Chronic Pain, Alcohol Use, Unspecified, HIV Infections
Interventions: Low-dose naltrexone, Gabapentin, Placebo
First posted: 2019-08-09
Last updated: 2022-11-10
Results first posted: 2022-11-10

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Change in Past Week Pain Severity	Baseline, 8-weeks	Change in past week pain severity (score 0 \[no pain\] -10 \[high pain\]) from baseline to week 8. Pain severity will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function
Primary	Change in Past Week Pain Interference	Baseline, 8-weeks	Change in past week pain interference (score 0 \[no pain\]-10 \[high pain\]) from baseline to week 8. Pain interference will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function
Secondary	Change in Cold Pain Tolerance	Baseline, 8-weeks	Mean change in the number of seconds a participant can keep their hand submerged in a container of iced water. Participants were instructed to keep their hand in as long as they could, up to 3 minutes.
Secondary	Change in Percentage of Past Month Heavy Drinking Days	Baseline, 8-weeks	Mean percentage of change in self-reported heavy drinking in the past 30 days of alcohol consumption obtained via the Timeline Followback (TLFB) method. The NIAAA definition of heavy drinking is used (\> 4 drinks in a day for men; \> 3 drinks in a day for women). Participants were asked about their alcohol consumption on each day in the previous 30 days.
Secondary	Change in CD4 Count	Baseline, 8-weeks	Defined as mean change in CD4 values from lab assay
Secondary	Number of Participants With a Change in HIV Viral Load Suppression Status	Baseline, 8-weeks	Defined as number of participants who change from suppressed to unsuppressed or unsuppressed to suppressed from lab tests
Secondary	Change in Biomarker IL-6	Baseline, 8-weeks	Mean change in IL-6 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
Secondary	Change in Biomarker IL-10	Baseline, 8 weeks	Mean change in IL-10 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
Secondary	Change in TNF-alpha	Baseline, 8-weeks	Mean change in TNF-alpha values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
Secondary	Change in IL-1beta	Baseline, 8-weeks	Mean change in IL-1beta values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Past Week Pain Severity	Baseline, 8-weeks	units on a scale	MEAN
PRIMARY	Change in Past Week Pain Interference	Baseline, 8-weeks	units on a scale	MEAN
SECONDARY	Change in Cold Pain Tolerance	Baseline, 8-weeks	seconds	MEAN
SECONDARY	Change in Percentage of Past Month Heavy Drinking Days	Baseline, 8-weeks	% of change in heavy drinking days	MEAN
SECONDARY	Change in CD4 Count	Baseline, 8-weeks	cell/mm^3	MEAN
SECONDARY	Number of Participants With a Change in HIV Viral Load Suppression Status	Baseline, 8-weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Biomarker IL-6	Baseline, 8-weeks	pg/ml	MEAN
SECONDARY	Change in Biomarker IL-10	Baseline, 8 weeks	pg/ml	MEAN
SECONDARY	Change in TNF-alpha	Baseline, 8-weeks	pg/ml	MEAN
SECONDARY	Change in IL-1beta	Baseline, 8-weeks	pg/ml	MEAN

Source ClinicalTrials.gov

Results by group30

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

Outcome	Group	Value	Spread	Units
Change in Past Week Pain Severity	Low-dose Naltrexone	-0.97	Standard Error 0.63	units on a scale
Change in Past Week Pain Severity	Gabapentin	-2.12	Standard Error 0.38	units on a scale
Change in Past Week Pain Severity	Placebo	-1.85	Standard Error 0.61	units on a scale
Change in Past Week Pain Interference	Low-dose Naltrexone	-1.73	Standard Error 0.47	units on a scale
Change in Past Week Pain Interference	Gabapentin	-1.97	Standard Error 0.64	units on a scale
Change in Past Week Pain Interference	Placebo	-2.14	Standard Error 0.58	units on a scale
Change in Cold Pain Tolerance	Low-dose Naltrexone	-14.78	Standard Error 7.61	seconds
Change in Cold Pain Tolerance	Gabapentin	-3.33	Standard Error 4.56	seconds
Change in Cold Pain Tolerance	Placebo	-3.15	Standard Error 6.89	seconds
Change in Percentage of Past Month Heavy Drinking Days	Low-dose Naltrexone	3.07	Standard Error 5.17	% of change in heavy drinking days

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Low-dose Naltrexone	15
Overall Study	STARTED	Gabapentin	15
Overall Study	STARTED	Placebo	15
Overall Study	4-weeks	Low-dose Naltrexone	14
Overall Study	4-weeks	Gabapentin	15
Overall Study	4-weeks	Placebo	15
Overall Study	8-weeks	Low-dose Naltrexone	12
Overall Study	8-weeks	Gabapentin	15
Overall Study	8-weeks	Placebo	15
Overall Study	12-weeks	Low-dose Naltrexone	12

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events57

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	Hypertension	Cardiac disorders	Low-dose Naltrexone	1	15	1
other	Hypertension	Cardiac disorders	Gabapentin	0	15	0
other	Hypertension	Cardiac disorders	Placebo	0	15	0
other	Fatigue	General disorders	Low-dose Naltrexone	3	15	3
other	Fatigue	General disorders	Gabapentin	0	15	0
other	Fatigue	General disorders	Placebo	1	15	1
other	Diarrhea	Gastrointestinal disorders	Low-dose Naltrexone	1	15	1
other	Diarrhea	Gastrointestinal disorders	Gabapentin	0	15	0
other	Diarrhea	Gastrointestinal disorders	Placebo	0	15	0
other	Stomach pain	Gastrointestinal disorders	Low-dose Naltrexone	1	15	1

1 to 10 of 57Source ClinicalTrials.gov

See all 57 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Low-dose Naltrexone	0	15
Total, all-cause mortality	Gabapentin	0	15
Total, all-cause mortality	Placebo	0	15
Total, other adverse events	Low-dose Naltrexone	4	15
Total, other adverse events	Gabapentin	5	15
Total, other adverse events	Placebo	2	15
Total, serious adverse events	Low-dose Naltrexone	1	15
Total, serious adverse events	Gabapentin	0	15
Total, serious adverse events	Placebo	1	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38408060	DERIVED

Source PubMed

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
UH3AA026193	Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation among HIV-Infected Persons with Alcohol Problems	SAMET, JEFFREY H.; TSUI, JUDITH	BOSTON MEDICAL CENTER	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2019 to 2021

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

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

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