Trial · NCT01218958
ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults
NCT01218958, Phase 3, Completed, Alkermes, Inc.; results first posted 2010-12-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults. Trials, record NCT01218958. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01218958
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults
- NCT number
- NCT01218958
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 624 participants, actual
- Lead sponsor
- Alkermes, Inc.
- Conditions
- Alcoholism
- Interventions
- Medisorb naltrexone 190 mg, Medisorb naltrexone 380 mg, Placebo matching Medisorb naltrexone 190 mg, Placebo matching Medisorb naltrexone 380 mg
- First posted
- 2010-10-13
- Last updated
- 2017-07-11
- Results first posted
- 2010-12-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Heavy Drinking Days Over the Treatment Period | Baseline through Week 24 (168 days) | Drinking rates were assessed from participants' self-reports using the validated Timeline Follow-Back (TLFB) method. Using a TLFB calendar, participants reported the number of days they had consumed alcohol along with the amount they consumed on each day. A heavy drinking day was defined as ≥5 drinks/day for men and ≥4 drinks/day for women. |
| Secondary | Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) | 24 weeks (Baseline to Week 24) | A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Heavy Drinking Days Over the Treatment Period | Baseline through Week 24 (168 days) | The last post-baseline observation carried forward (LOCF) of each participant in the intent-to-treat population (all randomized participants who received at least 1 injection of study drug) were utilized for the primary efficacy analysis. | Percentage of days | MEDIAN |
| SECONDARY | Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) | 24 weeks (Baseline to Week 24) | Participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Percentage of Heavy Drinking Days Over the Treatment Period | Medisorb Naltrexone 190 mg | 14.75 | Inter-Quartile Range 3.23 to 44.58 | Percentage of days | |
| Percentage of Heavy Drinking Days Over the Treatment Period | Medisorb Naltrexone 380 mg | 10.23 | Inter-Quartile Range 1.16 to 33.33 | Percentage of days | |
| Percentage of Heavy Drinking Days Over the Treatment Period | Placebo Groups (Pooled) | 19.77 | Inter-Quartile Range 6.01 to 50.15 | Percentage of days | |
| Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) | Medisorb Naltrexone 190 mg | 190 | Participants | ||
| Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) | Medisorb Naltrexone 380 mg | 187 | Participants | ||
| Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) | Placebo Groups (Pooled) | 181 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Medisorb Naltrexone 190 mg | 210 | |
| Overall Study | STARTED | Medisorb Naltrexone 380 mg | 205 | |
| Overall Study | STARTED | Placebo Groups (Pooled) | 209 | |
| Overall Study | COMPLETED | Medisorb Naltrexone 190 mg | 126 | |
| Overall Study | COMPLETED | Medisorb Naltrexone 380 mg | 124 | |
| Overall Study | COMPLETED | Placebo Groups (Pooled) | 128 | |
| Overall Study | NOT COMPLETED | Medisorb Naltrexone 190 mg | 84 | |
| Overall Study | NOT COMPLETED | Medisorb Naltrexone 380 mg | 81 | |
| Overall Study | NOT COMPLETED | Placebo Groups (Pooled) | 81 |
Source ClinicalTrials.gov
Adverse events126
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 | Nausea | Gastrointestinal disorders | Medisorb Naltrexone 190 mg | 53 | 210 | |
| other | Nausea | Gastrointestinal disorders | Medisorb Naltrexone 380 mg | 68 | 205 | |
| other | Nausea | Gastrointestinal disorders | Placebo Groups (Pooled) | 23 | 209 | |
| other | Diarrhoea NOS | Gastrointestinal disorders | Medisorb Naltrexone 190 mg | 23 | 210 | |
| other | Diarrhoea NOS | Gastrointestinal disorders | Medisorb Naltrexone 380 mg | 26 | 205 | |
| other | Diarrhoea NOS | Gastrointestinal disorders | Placebo Groups (Pooled) | 18 | 209 | |
| other | Vomiting NOS | Gastrointestinal disorders | Medisorb Naltrexone 190 mg | 22 | 210 | |
| other | Vomiting NOS | Gastrointestinal disorders | Medisorb Naltrexone 380 mg | 28 | 205 | |
| other | Vomiting NOS | Gastrointestinal disorders | Placebo Groups (Pooled) | 12 | 209 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Medisorb Naltrexone 190 mg | 17 | 210 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Medisorb Naltrexone 190 mg | ||
| Total, all-cause mortality | Medisorb Naltrexone 380 mg | ||
| Total, all-cause mortality | Placebo Groups (Pooled) | ||
| Total, other adverse events | Medisorb Naltrexone 190 mg | 190 | 210 |
| Total, other adverse events | Medisorb Naltrexone 380 mg | 187 | 205 |
| Total, other adverse events | Placebo Groups (Pooled) | 181 | 209 |
| Total, serious adverse events | Medisorb Naltrexone 190 mg | 10 | 210 |
| Total, serious adverse events | Medisorb Naltrexone 380 mg | 11 | 205 |
| Total, serious adverse events | Placebo Groups (Pooled) | 15 | 209 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
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 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.
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/NCT01218958
GET https://conductscience.org/api/trials/v1/NCT01218958/events?page=2