Trial · NCT02478489
Alcohol Disorder hOsPital Treatment Trial
NCT02478489, Phase 4, Completed, Boston University; results first posted 2021-06-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Alcohol Disorder hOsPital Treatment Trial. Trials, record NCT02478489. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02478489
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alcohol Disorder hOsPital Treatment Trial
- NCT number
- NCT02478489
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 248 participants, actual
- Lead sponsor
- Boston University
- Conditions
- Heavy Drinking, Alcohol Dependence, Alcohol Use Disorder
- Interventions
- Oral naltrexone (PO-NTX), Extended-release injectable naltrexone (XR-NTX)
- First posted
- 2015-06-23
- Last updated
- 2021-06-29
- Results first posted
- 2021-06-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Percent Heavy Drinking Days (%HDDs) Over the Past 30 Days From Baseline to 3 Month Follow-up, Assessed Using the Timeline Follow-Back | Baseline, 3 months | The primary alcohol use outcome will be change in percent heavy drinking days (%HDDs) from baseline to 3 month follow-up. %HDDs out of the past 30 days is assessed using the Timeline Follow-Back. %HDDs is the most likely (and most sensitive) to be affected by NTX and is clinically important (any reduction means less risk of harm). We chose self-report because biological testing is not sufficiently valid for detecting drinking levels and changes of clinical importance. The self-report tool is valid, particularly so when staff are well trained, and when the context for the subject is: they are informed they are being tested for consumption (breath alcohol and carbohydrate deficient transferrin (CDT), there are no consequences related to consumption levels, and that results are being recorded confidentially. |
| Secondary | Acute Care Hospital Utilization | 3 months | Any acute hospital utilization (emergency department visit or inpatient stay) over the past 90 days assessed at 3-month follow-up by the Form 90. Self-report for short-term high impact, memorable health utilization such as emergency and hospital stays is valid and can measure utilization at any site. Using the clinical data warehouse at one site (Boston Medical Center (BMC)) and statewide data, we will compare self-report to the utilization databases. But, self-report data will remain primary, with databases used to provide a descriptive frame of reference. |
| Other | Medication Adherence | 1, 2 and 3 months | High adherence to XR-NTX will be defined as administration of XR-NTX by the study nurse 3 times. Medium adherence will be defined as 1 or 2 injections. For PO-NTX, high adherence will be defined as participant self-report of taking PO-NTX for 90 out of the past 90 days at the 3 month study visit, and medium adherence as participant self-report of taking PO-NTX for 30-89 out of the past 90 days at the 3 month study visit (Form 90). We will also assess the presence of detectable beta-naltrexol to confirm reports of recent pill taking. |
| Other | Alcohol Consequences Via Questionnaire | 3 months | Alcohol consequences over the past 3 months will be measured by collecting participant self-report data via the Short Inventory of Problems (SIP-2R) at 3-month follow-up. The SIP-2R is a validated 15-item measure for assessing recent adverse consequences associated with alcohol use. |
| Other | Alcohol Use Disorder-related Treatment Utilization Via Questionnaire and Health Records | 3 months | Alcohol use disorder-related treatment utilization over the past 90 days assessed at 3-month follow-up by the Form 90. Using the clinical data warehouse at one site (Boston Medical Center (BMC)) and statewide data, we will compare self-report to the utilization databases. But, self-report data will remain primary, with databases used to provide a descriptive frame of reference. |
| Other | Cost Via Utilization Questionnaire, Health Records and Estimates From Local and National Sources | 3 and 12 months | Healthcare utilization cost data will be collected via the Form 90 for self-reported outpatient and emergency visits, hospitalizations, and specialty addiction treatment. Utilization episodes will be converted to costs by use of Medicare relative value units (RVUs) for acute inpatient care, Resource Based Relative Value System (RBRVS) units for Medicare reimbursement of outpatient visits, and the average daily rate for long-term care. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Percent Heavy Drinking Days (%HDDs) Over the Past 30 Days From Baseline to 3 Month Follow-up, Assessed Using the Timeline Follow-Back | Baseline, 3 months | Analysis population includes those who completed the 3 month follow-up assessment. Population does not match baseline sample due to attrition / loss to follow-up. | change in percent heavy drinking days | MEAN |
| SECONDARY | Acute Care Hospital Utilization | 3 months | Analysis population includes those who completed the 3 month follow-up assessment. Population does not match baseline sample due to attrition / loss to follow-up. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Medication Adherence | 1, 2 and 3 months | |||
| OTHER_PRE_SPECIFIED | Alcohol Consequences Via Questionnaire | 3 months | |||
| OTHER_PRE_SPECIFIED | Alcohol Use Disorder-related Treatment Utilization Via Questionnaire and Health Records | 3 months | |||
| OTHER_PRE_SPECIFIED | Cost Via Utilization Questionnaire, Health Records and Estimates From Local and National Sources | 3 and 12 months |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Percent Heavy Drinking Days (%HDDs) Over the Past 30 Days From Baseline to 3 Month Follow-up, Assessed Using the Timeline Follow-Back | Extended-release Injectable Naltrexone (XR-NTX) | -46.4 | Standard Deviation 38.5 | change in percent heavy drinking days | |
| Change in Percent Heavy Drinking Days (%HDDs) Over the Past 30 Days From Baseline to 3 Month Follow-up, Assessed Using the Timeline Follow-Back | Oral Naltrexone (PO-NTX) | -38.4 | Standard Deviation 43.3 | change in percent heavy drinking days | |
| Acute Care Hospital Utilization | Extended-release Injectable Naltrexone (XR-NTX) | Any acute care hospital utilization (emergency department visit or inpatient stay) | 66 | Participants | |
| Acute Care Hospital Utilization | Oral Naltrexone (PO-NTX) | Any acute care hospital utilization (emergency department visit or inpatient stay) | 59 | Participants | |
| Acute Care Hospital Utilization | Extended-release Injectable Naltrexone (XR-NTX) | No acute care hospital utilization (emergency department visit or inpatient stay) | 42 | Participants | |
| Acute Care Hospital Utilization | Oral Naltrexone (PO-NTX) | No acute care hospital utilization (emergency department visit or inpatient stay) | 50 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Extended-release Injectable Naltrexone (XR-NTX) | 123 | |
| Overall Study | STARTED | Oral Naltrexone (PO-NTX) | 125 | |
| Overall Study | COMPLETED | Extended-release Injectable Naltrexone (XR-NTX) | 108 | |
| Overall Study | COMPLETED | Oral Naltrexone (PO-NTX) | 109 | |
| Overall Study | NOT COMPLETED | Extended-release Injectable Naltrexone (XR-NTX) | 15 | |
| Overall Study | NOT COMPLETED | Oral Naltrexone (PO-NTX) | 16 |
Source ClinicalTrials.gov
Adverse events122
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 Liver Function Tests | Hepatobiliary disorders | Extended-release Injectable Naltrexone (XR-NTX) | 19 | 123 | |
| other | Elevated Liver Function Tests | Hepatobiliary disorders | Oral Naltrexone (PO-NTX) | 32 | 125 | |
| other | Injection Site Discomfort | Skin and subcutaneous tissue disorders | Extended-release Injectable Naltrexone (XR-NTX) | 36 | 123 | |
| other | Injection Site Discomfort | Skin and subcutaneous tissue disorders | Oral Naltrexone (PO-NTX) | 0 | 0 | |
| other | Intoxication | Injury, poisoning and procedural complications | Extended-release Injectable Naltrexone (XR-NTX) | 16 | 123 | |
| other | Intoxication | Injury, poisoning and procedural complications | Oral Naltrexone (PO-NTX) | 12 | 125 | |
| serious | Abdominal Pain | Gastrointestinal disorders | Extended-release Injectable Naltrexone (XR-NTX) | 1 | 123 | |
| serious | Abdominal Pain | Gastrointestinal disorders | Oral Naltrexone (PO-NTX) | 4 | 125 | |
| serious | Acute Cholecystitis | Hepatobiliary disorders | Extended-release Injectable Naltrexone (XR-NTX) | 0 | 123 | |
| serious | Acute Cholecystitis | Hepatobiliary disorders | Oral Naltrexone (PO-NTX) | 1 | 125 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Extended-release Injectable Naltrexone (XR-NTX) | 2 | 123 |
| Total, all-cause mortality | Oral Naltrexone (PO-NTX) | 3 | 125 |
| Total, other adverse events | Extended-release Injectable Naltrexone (XR-NTX) | 59 | 123 |
| Total, other adverse events | Oral Naltrexone (PO-NTX) | 39 | 125 |
| Total, serious adverse events | Extended-release Injectable Naltrexone (XR-NTX) | 43 | 123 |
| Total, serious adverse events | Oral Naltrexone (PO-NTX) | 43 | 125 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40257810 | 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 |
|---|---|---|---|---|---|
| R01AA021335 | Oral v Injection Naltrexone in Hospital: Comparative Effectiveness for Alcoholism | SAITZ, RICHARD | BOSTON UNIVERSITY MEDICAL CAMPUS | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2014 to 2019 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Extended-release Injectable Naltrexone (XR-NTX) vs Oral Naltrexone (PO-NTX): deaths from any cause | Trial comparisons |
| Extended-release Injectable Naltrexone (XR-NTX) vs Oral Naltrexone (PO-NTX): 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/NCT02478489
GET https://conductscience.org/api/trials/v1/NCT02478489/events?page=2