Trial · NCT03852628

Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD

NCT03852628, Phase 2, Terminated, Pharmacotherapies for Alcohol and Substance Use Disorders Alliance; results first posted 2023-06-07

3 sourcestrials-2026-11-12-0.5.0

Download JSON

Cite this record

ConductScience Library. Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD. Trials, record NCT03852628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03852628

On this page

Trial

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

Title: Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD
NCT number: NCT03852628
Status: Terminated
Phases: Phase 2
Enrollment: 69 participants, actual
Lead sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Conditions: Post Traumatic Stress Disorder, Alcohol Abuse
Interventions: 2mg Buprenex and 380mg Vivitrol, Placebo (SL pill qd, IM injection q4weeks)
First posted: 2019-02-25
Last updated: 2023-09-14
Results first posted: 2023-06-07
Limitations and caveats: There are no secondary outcome results to report as this study was closed for futility before enough data was collected to report secondary outcomes. .

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Number of Participants With a Reduction in Alcohol Use Disorder (AUD), With TLFB Tool	Baseline and 8 weeks	Timeline Follow Back (TLFB) is a calendar-based method of assessing drinking patterns used to document the frequency and amount of daily alcohol consumption and to categorize the World Health Organization Risk Levels of Alcohol Use. An AUD reduction is defined as a WHO risk reduction of at least one category from baseline to week 8. The are 4 different WHO Risk Levels based on the grams of alcohol consumed per day: Very High Risk, High Risk, Medium Risk, and Low Risk (including abstinence).
Primary	Number of Participants With a Reduction in CAPS-5 Total Symptom Severity Score (TSSS) of 10 or More Points	Baseline and 8 weeks	The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item structured interview to assess PTSD diagnosis and symptom severity. The CAPS-5 produces a PTSD Total Symptom Severity Score (TSSS) that ranges from 0 to 80, with a higher score indication worse PTSD symptoms. For this study, a reduction in PTSD symptoms is defined as a 10 or more point decrease in the CAPS-5 Total Symptom Severity Score (TSSS) from baseline to week 8.
Primary	Composite Outcome Measure for a Reduction in Both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD) Symptoms	Baseline and 8 Weeks	AUD is measured by the Timeline Follow Back (TLFB). This instrument documents the amount of daily alcohol consumption (in grams) and categorizes the World Health Organization Risk Levels of Alcohol Use. The are 4 different WHO Risk Levels: Very High Risk, High Risk, Medium Risk, and Low Risk (including abstinence). An AUD reduction is defined as a WHO risk reduction of at least one category from baseline to week 8. PTSD symptom is measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). This 30-item interview assesses PTSD diagnosis and symptom severity. The CAPS-5 Total Symptom Severity Score (TSSS) ranges from 0 to 80, with higher scores indicating worse symptoms. A reduction in PTSD symptom is defined as a 10+ point decrease in the TSSS from baseline to week 8. A positive response for the composite primary outcome measure is defined as at least a 1-category risk reduction on the WHO s and at least a 10-point decrease in TSSS from baseline to Week 8.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With a Reduction in Alcohol Use Disorder (AUD), With TLFB Tool	Baseline and 8 weeks	Includes all randomized participants that completed the baseline and Week 8 visit, and reported enough consecutive days of alcohol consumption at the week 8 visit (defined as being within one standard deviation of the population mean for the 28-day look back period).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With a Reduction in CAPS-5 Total Symptom Severity Score (TSSS) of 10 or More Points	Baseline and 8 weeks	All randomized participants that completed the baseline and week 8 visit.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Composite Outcome Measure for a Reduction in Both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD) Symptoms	Baseline and 8 Weeks	Includes all randomized participants that completed the baseline and Week 8 visit, and reported enough consecutive days of alcohol consumption at the week 8 visit (defined as being within one standard deviation of the population mean for the 28-day look back period).	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Units
Number of Participants With a Reduction in Alcohol Use Disorder (AUD), With TLFB Tool	2mg Buprenex and 380mg Vivitrol	17	Participants
Number of Participants With a Reduction in Alcohol Use Disorder (AUD), With TLFB Tool	Placebo	23	Participants
Number of Participants With a Reduction in CAPS-5 Total Symptom Severity Score (TSSS) of 10 or More Points	2mg Buprenex and 380mg Vivitrol	14	Participants
Number of Participants With a Reduction in CAPS-5 Total Symptom Severity Score (TSSS) of 10 or More Points	Placebo	15	Participants
Composite Outcome Measure for a Reduction in Both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD) Symptoms	2mg Buprenex and 380mg Vivitrol	10	Participants
Composite Outcome Measure for a Reduction in Both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD) Symptoms	Placebo	12	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	2mg Buprenex and 380mg Vivitrol	35
Overall Study	STARTED	Placebo	34
Overall Study	COMPLETED	2mg Buprenex and 380mg Vivitrol	22
Overall Study	COMPLETED	Placebo	22
Overall Study	NOT COMPLETED	2mg Buprenex and 380mg Vivitrol	13
Overall Study	NOT COMPLETED	Placebo	12

Source ClinicalTrials.gov

Adverse events116

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	Abdominal cramps	Gastrointestinal disorders	2mg Buprenex and 380mg Vivitrol	0	35	0
other	Abdominal cramps	Gastrointestinal disorders	Placebo	1	34	1
other	Acid reflux (esophageal)	Gastrointestinal disorders	2mg Buprenex and 380mg Vivitrol	0	35	0
other	Acid reflux (esophageal)	Gastrointestinal disorders	Placebo	1	34	1
other	Adverse drug reaction	General disorders	2mg Buprenex and 380mg Vivitrol	1	35	1
other	Adverse drug reaction	General disorders	Placebo	0	34	0
other	Alcohol withdrawal syndrome	Psychiatric disorders	2mg Buprenex and 380mg Vivitrol	2	35	3
other	Alcohol withdrawal syndrome	Psychiatric disorders	Placebo	0	34	0
other	Alcoholic seizure	Nervous system disorders	2mg Buprenex and 380mg Vivitrol	1	35	1
other	Alcoholic seizure	Nervous system disorders	Placebo	0	34	0

1 to 10 of 116Source ClinicalTrials.gov

See all 116 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	2mg Buprenex and 380mg Vivitrol	0	35
Total, all-cause mortality	Placebo	0	34
Total, other adverse events	2mg Buprenex and 380mg Vivitrol	22	35
Total, other adverse events	Placebo	16	34
Total, serious adverse events	2mg Buprenex and 380mg Vivitrol	3	35
Total, serious adverse events	Placebo	0	34

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons5

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

Comparison	Source
2mg Buprenex and 380mg Vivitrol vs Placebo: Composite Outcome Measure for a Reduction in Both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD) Symptoms	Trial comparisons
2mg Buprenex and 380mg Vivitrol vs Placebo: Number of Participants With a Reduction in CAPS-5 Total Symptom Severity Score (TSSS) of 10 or More Points	Trial comparisons
2mg Buprenex and 380mg Vivitrol vs Placebo: Number of Participants With a Reduction in Alcohol Use Disorder (AUD), With TLFB Tool	Trial comparisons
2mg Buprenex and 380mg Vivitrol vs Placebo: deaths from any cause	Trial comparisons
2mg Buprenex and 380mg Vivitrol vs 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.

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/NCT03852628

GET https://conductscience.org/api/trials/v1/NCT03852628/events?page=2

API reference For AI assistants