Trial · NCT03278886

St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene

NCT03278886, Phase 1, Phase 2, Completed, Boston Medical Center; results first posted 2020-08-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene. Trials, record NCT03278886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03278886

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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 Nalmefene
NCT number: NCT03278886
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 11 participants, actual
Lead sponsor: Boston Medical Center
Conditions: HIV Infection, Alcohol Use, Pain
Interventions: Low dose naltrexone, Nalmefene
First posted: 2017-09-12
Last updated: 2020-08-24
Results first posted: 2020-08-03

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Medication Tolerability Measured Via a 0-100 Visual Analog Scale	Primary endpoint at 8 weeks	Medication tolerability will be measured via a 0-100 visual analog scale. Participants will be asked to indicate on a scale of 0-100, how well they have tolerated the study medication with 0 anchored as "cannot tolerate at all" and 100 as "tolerate perfectly well." Higher numbers will be indicative of higher tolerability of the medication.
Secondary	Change in Alcohol Use Defined as a Change in the Mean Number of Grams of Pure Ethanol Consumed Per Day From Baseline to 8 Weeks	Baseline, 8 weeks	Measured via 30 Day Alcohol Use Timeline Follow Back Method
Secondary	Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period	4 weeks, 8 weeks	Measured via one question asking participants if they had discontinued medication since their last visit. Assessed at 4 and 8 week study visits.
Secondary	Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks	Endpoint at 8 weeks	Measured by participants' drawing a line on a a Visual Analog Scale, which ranges from 0 to 100. Higher numbers indicate higher adherence to study medication.
Secondary	Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming Adherence	Endpoint at 8 weeks	Measured through visual inspection of the urine for the presence or absence of riboflavin using ultraviolet (UV) light at the long wave setting (33 mm) in a room with low ambient light.
Secondary	Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question	2 weeks, 4 weeks, 6 weeks, 8 weeks	Measured via a 16-item symptom checklist with the option for participants to report any experienced side effects not on the checklist. Side effect severity is rated by trained research assessors. The checklist is asked at 2, 4, 6, and 8-week study visits.
Secondary	Medication Satisfaction Defined as a Score From 0-100 Measured Via the Treatment Satisfaction Questionnaire for Medication (TSQM), With Higher Scores Corresponding to Higher Treatment Satisfaction.	4 weeks, 8 weeks	Measured via using the 14-item Treatment Satisfaction Questionnaire, which consists of 14 items that result in four domains: Effectiveness, Side Effects, Convenience and Global Satisfaction. Higher scores indicate greater satisfaction with medication. Assessed at 4 and 8 week study visits.
Secondary	Severe Hepatotoxicity Defined as AST/ALT >10X the Level of Normal	Endpoint at 8 weeks	Aminotransferase levels (AST/ALT) are tested to look for severe hepatotoxicity defined as AST/ALT \> 10 times the level of normal.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Medication Tolerability Measured Via a 0-100 Visual Analog Scale	Primary endpoint at 8 weeks	score on a scale	MEAN
SECONDARY	Change in Alcohol Use Defined as a Change in the Mean Number of Grams of Pure Ethanol Consumed Per Day From Baseline to 8 Weeks	Baseline, 8 weeks	grams of ethanol	MEAN
SECONDARY	Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period	4 weeks, 8 weeks	treatment discontinuations	NUMBER
SECONDARY	Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks	Endpoint at 8 weeks	score on a scale	MEAN
SECONDARY	Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming Adherence	Endpoint at 8 weeks	participants	NUMBER
SECONDARY	Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question	2 weeks, 4 weeks, 6 weeks, 8 weeks	number of side effects	MEAN
SECONDARY	Medication Satisfaction Defined as a Score From 0-100 Measured Via the Treatment Satisfaction Questionnaire for Medication (TSQM), With Higher Scores Corresponding to Higher Treatment Satisfaction.	4 weeks, 8 weeks	score on a scale	MEAN
SECONDARY	Severe Hepatotoxicity Defined as AST/ALT >10X the Level of Normal	Endpoint at 8 weeks	participants	NUMBER

Source ClinicalTrials.gov

Results by group26

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

Outcome	Group	Category	Value	Spread	Units
Medication Tolerability Measured Via a 0-100 Visual Analog Scale	Low Dose Naltrexone		90.7	Standard Deviation 22.4	score on a scale
Medication Tolerability Measured Via a 0-100 Visual Analog Scale	Nalmefene		NA	Standard Deviation NA	score on a scale
Change in Alcohol Use Defined as a Change in the Mean Number of Grams of Pure Ethanol Consumed Per Day From Baseline to 8 Weeks	Low Dose Naltrexone		5.5	Standard Deviation 10.1	grams of ethanol
Change in Alcohol Use Defined as a Change in the Mean Number of Grams of Pure Ethanol Consumed Per Day From Baseline to 8 Weeks	Nalmefene		-6.83	Standard Deviation 9.7	grams of ethanol
Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period	Low Dose Naltrexone	4-Weeks	1		treatment discontinuations
Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period	Nalmefene	4-Weeks	1		treatment discontinuations
Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period	Low Dose Naltrexone	8-Weeks	1		treatment discontinuations
Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period	Nalmefene	8-Weeks	2		treatment discontinuations
Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks	Low Dose Naltrexone		87.5	Standard Deviation 35.4	score on a scale
Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks	Nalmefene		0	Standard Deviation 0	score on a scale

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Low Dose Naltrexone	8
Overall Study	STARTED	Nalmefene	3
Overall Study	COMPLETED	Low Dose Naltrexone	8
Overall Study	COMPLETED	Nalmefene	2
Overall Study	NOT COMPLETED	Low Dose Naltrexone	0
Overall Study	NOT COMPLETED	Nalmefene	1

Source ClinicalTrials.gov

Adverse events28

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	Agitation	General disorders	Low Dose Naltrexone	0	8	0
other	Agitation	General disorders	Nalmefene	1	3	1
other	Irritability	General disorders	Low Dose Naltrexone	0	8	0
other	Irritability	General disorders	Nalmefene	1	3	1
other	Weakness	General disorders	Low Dose Naltrexone	0	8	0
other	Weakness	General disorders	Nalmefene	2	3	2
other	Nausea	Gastrointestinal disorders	Low Dose Naltrexone	0	8	0
other	Nausea	Gastrointestinal disorders	Nalmefene	2	3	2
other	Dizziness	Nervous system disorders	Low Dose Naltrexone	0	8	0
other	Dizziness	Nervous system disorders	Nalmefene	2	3	2

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Low Dose Naltrexone	0	8
Total, all-cause mortality	Nalmefene	0	3
Total, other adverse events	Low Dose Naltrexone	3	8
Total, other adverse events	Nalmefene	3	3
Total, serious adverse events	Low Dose Naltrexone	1	8
Total, serious adverse events	Nalmefene	0	3

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33682527	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
UH2AA026193	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	2017 to 2018

Source NIH RePORTER

Trial comparisons4

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

Comparison	Source
Low Dose Naltrexone vs Nalmefene: Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming Adherence	Trial comparisons
Low Dose Naltrexone vs Nalmefene: Severe Hepatotoxicity Defined as AST/ALT >10X the Level of Normal	Trial comparisons
Low Dose Naltrexone vs Nalmefene: deaths from any cause	Trial comparisons
Low Dose Naltrexone vs Nalmefene: 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.

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/NCT03278886

GET https://conductscience.org/api/trials/v1/NCT03278886/results?page=2

API reference For AI assistants