Trial · NCT01893827
Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care
NCT01893827, Phase 4, Completed, NYU Langone Health; results first posted 2020-06-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care. Trials, record NCT01893827. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01893827
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care
- NCT number
- NCT01893827
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 237 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Alcohol Dependence
- Interventions
- XR-NTX (Extended-Release Naltrexone), Oral Naltrexone (O-NTX)
- First posted
- 2013-07-09
- Last updated
- 2020-06-16
- Results first posted
- 2020-06-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Alcohol Abstinence or Moderate Drinking | 4-24 weeks | Percentage of participants who had the following number of drinks (≤2 drinks/day, men; ≤1 drink/day, women; and ≤2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management for alcohol dependence. |
| Other | Cost-effectiveness | 0-24 weeks | To estimate the incremental cost-effectiveness of XR-NTX vs. O-NTX, both in conjunction with primary care-based medical management. Economic data will be derived primarily from the Economic Form 90, Non-Study Medical Service and electronic medical records assessments, EQ-5D (functional status), and a cost survey or standardized question querying patient reports of specific non-medical related costs (including lost/gained work, lost/gained dependent care, transportation costs, arrests, motor vehicle accidents) collected at baseline and at week 10, 18, 26, and 48 assessments. |
| Other | Patient-level Predictors of Effectiveness | 4-24 weeks | To identify patient-level characteristics (gender, ethnicity, pre-treatment abstinence, voluntary specialty alcohol treatment and Alcoholics Anonymous involvement) associated with effectiveness in both arms. Baseline Demographic and Timeline Follow-Back and in-study Non-Study Medical Service questionnaires will characterized these patient-level variables. |
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 | Percentage of Participants With Alcohol Abstinence or Moderate Drinking | 4-24 weeks | percentage of participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Cost-effectiveness | 0-24 weeks | |||
| OTHER_PRE_SPECIFIED | Patient-level Predictors of Effectiveness | 4-24 weeks |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Alcohol Abstinence or Moderate Drinking | XR-NTX | 29 | percentage of participants | ||
| Percentage of Participants With Alcohol Abstinence or Moderate Drinking | Oral Naltrexone | 23 | percentage of 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 | XR-NTX | 117 | |
| Overall Study | STARTED | Oral Naltrexone | 120 | |
| Overall Study | COMPLETED | XR-NTX | 98 | |
| Overall Study | COMPLETED | Oral Naltrexone | 94 | |
| Overall Study | NOT COMPLETED | XR-NTX | 19 | |
| Overall Study | NOT COMPLETED | Oral Naltrexone | 26 |
Source ClinicalTrials.gov
Adverse events52
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 | ER Visit | General disorders | XR-NTX | 19 | 117 | |
| other | ER Visit | General disorders | Oral Naltrexone | 18 | 120 | |
| other | Scrotal Infection | Infections and infestations | XR-NTX | 1 | 117 | |
| other | Scrotal Infection | Infections and infestations | Oral Naltrexone | 0 | 120 | |
| other | Anosmia | General disorders | XR-NTX | 1 | 117 | |
| other | Anosmia | General disorders | Oral Naltrexone | 0 | 120 | |
| other | Decreased Libido | General disorders | XR-NTX | 2 | 117 | |
| other | Decreased Libido | General disorders | Oral Naltrexone | 0 | 120 | |
| other | Depressed Mood | Psychiatric disorders | XR-NTX | 1 | 117 | |
| other | Depressed Mood | Psychiatric disorders | Oral Naltrexone | 1 | 120 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | XR-NTX | 2 | 117 |
| Total, all-cause mortality | Oral Naltrexone | 0 | 120 |
| Total, other adverse events | XR-NTX | 19 | 117 |
| Total, other adverse events | Oral Naltrexone | 18 | 120 |
| Total, serious adverse events | XR-NTX | 22 | 117 |
| Total, serious adverse events | Oral Naltrexone | 20 | 120 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| XR-NTX vs Oral Naltrexone: deaths from any cause | Trial comparisons |
| XR-NTX vs Oral Naltrexone: 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/NCT01893827
GET https://conductscience.org/api/trials/v1/NCT01893827/events?page=2