Trial · NCT00678418
ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence
NCT00678418, Phase 3, Completed, Alkermes, Inc.; results first posted 2011-01-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence. Trials, record NCT00678418. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00678418
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence
- NCT number
- NCT00678418
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 250 participants, actual
- Lead sponsor
- Alkermes, Inc.
- Conditions
- Opiate Dependence
- Interventions
- VIVITROL® 380 mg, Placebo
- First posted
- 2008-05-15
- Last updated
- 2017-02-10
- Results first posted
- 2011-01-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A) | 20 weeks | Included are data from the last 20 weeks of the 24-week double-blind treatment period (Part A). Response profiles for each Arm are based on subjects' individual rates of weekly opioid-free data, including negative urine test results, attendance at study visits, and self-reports of opioid use/non-use. |
| Secondary | Days to Discontinuation During Part A | 168 days (24 weeks) | Defined as the duration of study participation and calculated as the number of days from Dose 1 to the day of study discontinuation. |
| Secondary | Craving Score: Change From Baseline | Baseline to 6 months (24 weeks) | Measured using subjects' response on a validated Visual Analog Scale at prespecified weekly visits throughout Part A, with comparison of baseline to end of Part A. The scale ranged from 0 ("No craving") to 100 ("highest possible craving"). |
| Secondary | Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A) | 24 Weeks | Assessment of relapse to physiologic opioid dependence was based on individual subjects' results on the naloxone challenge test. A positive naloxone challenge test result was considered as a relapse to physiologic opioid dependence. |
| Secondary | Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24 | 24 Weeks | Opioid use was measured using subjects' entries on a validated Timeline FollowBack (TLFB) calendar in which they recorded their use/non-use of opioids each day. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A) | 20 weeks | Analyses include all randomized subjects who received at least 1 dose of study drug (Intent-to-treat \[ITT\] population). | Percentage of opioid-free weeks | MEDIAN |
| SECONDARY | Days to Discontinuation During Part A | 168 days (24 weeks) | Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population). | Days to study discontinuation | MEDIAN |
| SECONDARY | Craving Score: Change From Baseline | Baseline to 6 months (24 weeks) | Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population). | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A) | 24 Weeks | Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population). | Percentage of participants who relapsed | NUMBER |
| SECONDARY | Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24 | 24 Weeks | Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population). Change from baseline was calculated per subject as the percent of subjects' self-reported opioid-free days in Part A minus the percent of opioid-free days prior to the subjects' hospitalization for pre-study detoxification. | Percentage of opioid-free days | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A) | VIVITROL® 380 mg | 90.0 | Inter-Quartile Range 40.1 | Percentage of opioid-free weeks | |
| Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A) | Placebo | 35.0 | Inter-Quartile Range 43.3 | Percentage of opioid-free weeks | |
| Days to Discontinuation During Part A | VIVITROL® 380 mg | NA | 95% Confidence Interval NA to NA | Days to study discontinuation | |
| Days to Discontinuation During Part A | Placebo | 96.0 | 95% Confidence Interval 63.0 to 165.0 | Days to study discontinuation | |
| Craving Score: Change From Baseline | VIVITROL® 380 mg | -10.087 | 95% Confidence Interval -12.333 to -7.840 | Units on a scale | |
| Craving Score: Change From Baseline | Placebo | 0.654 | 95% Confidence Interval -3.139 to 4.446 | Units on a scale | |
| Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A) | VIVITROL® 380 mg | 46.8 | Percentage of participants who relapsed | ||
| Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A) | Placebo | 62.1 | Percentage of participants who relapsed | ||
| Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24 | VIVITROL® 380 mg | 75.83 | Inter-Quartile Range 32.14 to 100.00 | Percentage of opioid-free days | |
| Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24 | Placebo | 46.43 | Inter-Quartile Range 11.01 to 96.76 | Percentage of opioid-free days |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (Double Blind) | STARTED | VIVITROL® 380 mg | 126 | |
| Part A (Double Blind) | STARTED | Placebo | 124 | |
| Part A (Double Blind) | COMPLETED | VIVITROL® 380 mg | 67 | |
| Part A (Double Blind) | COMPLETED | Placebo | 47 | |
| Part A (Double Blind) | NOT COMPLETED | VIVITROL® 380 mg | 59 | |
| Part A (Double Blind) | NOT COMPLETED | Placebo | 77 | |
| Part B (Open Label) | STARTED | VIVITROL® 380 mg | 114 | |
| Part B (Open Label) | STARTED | Placebo | 0 | |
| Part B (Open Label) | COMPLETED | VIVITROL® 380 mg | 71 | |
| Part B (Open Label) | COMPLETED | Placebo | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events58
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 | Alanine aminotransferase increased | Investigations | VIVITROL® 380 mg | 16 | 126 | |
| other | Alanine aminotransferase increased | Investigations | Placebo | 7 | 124 | |
| other | Aspartate aminotransferase increased | Investigations | VIVITROL® 380 mg | 13 | 126 | |
| other | Aspartate aminotransferase increased | Investigations | Placebo | 3 | 124 | |
| other | Gamma-glutamyl transferase increased | Investigations | VIVITROL® 380 mg | 9 | 126 | |
| other | Gamma-glutamyl transferase increased | Investigations | Placebo | 4 | 124 | |
| other | Nasopharyngitis | Infections and infestations | VIVITROL® 380 mg | 9 | 126 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 124 | |
| other | Influenza | Infections and infestations | VIVITROL® 380 mg | 6 | 126 | |
| other | Influenza | Infections and infestations | Placebo | 5 | 124 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VIVITROL® 380 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | VIVITROL® 380 mg | 63 | 126 |
| Total, other adverse events | Placebo | 40 | 124 |
| Total, serious adverse events | VIVITROL® 380 mg | 3 | 126 |
| Total, serious adverse events | Placebo | 4 | 124 |
Source ClinicalTrials.gov
Papers6
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| VIVITROL® 380 mg vs Placebo: 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/NCT00678418
GET https://conductscience.org/api/trials/v1/NCT00678418/events?page=2