Trial · NCT00501631
ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence
NCT00501631, Phase 3, Completed, Alkermes, Inc.; results first posted 2011-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence. Trials, record NCT00501631. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00501631
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence
- NCT number
- NCT00501631
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- Alkermes, Inc.
- Conditions
- Alcohol Dependence
- Interventions
- VIVITROL 380 mg, Placebo for VIVITROL 380 mg
- First posted
- 2007-07-16
- Last updated
- 2011-09-22
- Results first posted
- 2011-04-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Percentage of Participants by Heavy Drinking Rate | up to 12 weeks | Cumulative percentage (%) of subjects reporting heavy drinking by category reflecting the various cut-offs for percentage of days that were heavy drinking days. A "heavy drinking day" was defined as 4 or more alcohol drinks in 1 day for women, and 5 or more alcohol drinks in 1 day for men. The Timeline Follow-Back (TLFB) method (Sobell \& Sobell: Humana Press, 1992) was utilized to collect subjects' daily drinking information (ie, the number of drinks consumed per day per subject which was retrospectively recalled and recorded in a diary). |
| Secondary | Longer-term Safety of VIVITROL | up to 1 year | Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study. |
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 | Cumulative Percentage of Participants by Heavy Drinking Rate | up to 12 weeks | The primary endpoint is based on percentage rate of heavy drinking days during the double-blind treatment period as per protocol. | percentage of participants | NUMBER |
| SECONDARY | Longer-term Safety of VIVITROL | up to 1 year | participants | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative Percentage of Participants by Heavy Drinking Rate | Vivitrol | 0% Heavy Drinking Days | 40.8 | percentage of participants | |
| Cumulative Percentage of Participants by Heavy Drinking Rate | Placebo | 0% Heavy Drinking Days | 47.3 | percentage of participants | |
| Cumulative Percentage of Participants by Heavy Drinking Rate | Vivitrol | <= 10% Heavy Drinking Days | 59.2 | percentage of participants | |
| Cumulative Percentage of Participants by Heavy Drinking Rate | Placebo | <= 10% Heavy Drinking Days | 59.5 | percentage of participants | |
| Cumulative Percentage of Participants by Heavy Drinking Rate | Vivitrol | <= 20% Heavy Drinking Days | 65.8 | percentage of participants | |
| Cumulative Percentage of Participants by Heavy Drinking Rate | Placebo | <= 20% Heavy Drinking Days | 72.3 | percentage of participants | |
| Cumulative Percentage of Participants by Heavy Drinking Rate | Vivitrol | <= 30% Heavy Drinking Days | 74.3 | percentage of participants | |
| Cumulative Percentage of Participants by Heavy Drinking Rate | Placebo | <= 30% Heavy Drinking Days | 79.1 | percentage of participants | |
| Cumulative Percentage of Participants by Heavy Drinking Rate | Vivitrol | <= 40% Heavy Drinking Days | 80.9 | percentage of participants | |
| Cumulative Percentage of Participants by Heavy Drinking Rate | Placebo | <= 40% Heavy Drinking Days | 83.1 | percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (Double-blind Period) | STARTED | VIVITROL 380 mg | 152 | |
| Part A (Double-blind Period) | STARTED | Placebo for VIVITROL 380 mg | 148 | |
| Part A (Double-blind Period) | COMPLETED | VIVITROL 380 mg | 90 | |
| Part A (Double-blind Period) | COMPLETED | Placebo for VIVITROL 380 mg | 99 | |
| Part A (Double-blind Period) | NOT COMPLETED | VIVITROL 380 mg | 62 | |
| Part A (Double-blind Period) | NOT COMPLETED | Placebo for VIVITROL 380 mg | 49 | |
| Part B (Open-label Period) | STARTED | VIVITROL 380 mg | 90 | |
| Part B (Open-label Period) | STARTED | Placebo for VIVITROL 380 mg | 99 | |
| Part B (Open-label Period) | COMPLETED | VIVITROL 380 mg | 37 | |
| Part B (Open-label Period) | COMPLETED | Placebo for VIVITROL 380 mg | 48 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events88
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 | Injection site pain | General disorders | VIVITROL 380 mg (Double-blind Period) | 54 | 152 | |
| other | Injection site pain | General disorders | Placebo for VIVITROL 380 mg (Double-blind Period) | 59 | 148 | |
| other | Fatigue | General disorders | VIVITROL 380 mg (Double-blind Period) | 15 | 152 | |
| other | Fatigue | General disorders | Placebo for VIVITROL 380 mg (Double-blind Period) | 5 | 148 | |
| other | Injection site induration | General disorders | VIVITROL 380 mg (Double-blind Period) | 7 | 152 | |
| other | Injection site induration | General disorders | Placebo for VIVITROL 380 mg (Double-blind Period) | 3 | 148 | |
| other | Influenza like illness | General disorders | VIVITROL 380 mg (Double-blind Period) | 5 | 152 | |
| other | Influenza like illness | General disorders | Placebo for VIVITROL 380 mg (Double-blind Period) | 3 | 148 | |
| other | Alcoholism | Psychiatric disorders | VIVITROL 380 mg (Double-blind Period) | 25 | 152 | |
| other | Alcoholism | Psychiatric disorders | Placebo for VIVITROL 380 mg (Double-blind Period) | 40 | 148 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VIVITROL 380 mg (Double-blind Period) | ||
| Total, all-cause mortality | Placebo for VIVITROL 380 mg (Double-blind Period) | ||
| Total, other adverse events | VIVITROL 380 mg (Double-blind Period) | 135 | 152 |
| Total, other adverse events | Placebo for VIVITROL 380 mg (Double-blind Period) | 133 | 148 |
| Total, serious adverse events | VIVITROL 380 mg (Double-blind Period) | 29 | 152 |
| Total, serious adverse events | Placebo for VIVITROL 380 mg (Double-blind Period) | 27 | 148 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| VIVITROL 380 mg (Double-blind Period) vs Placebo for VIVITROL 380 mg (Double-blind Period): serious adverse events |
Source 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/NCT00501631
GET https://conductscience.org/api/trials/v1/NCT00501631/results?page=2