Trial · NCT02537574
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
NCT02537574, Phase 3, Completed, Alkermes, Inc.; results first posted 2019-01-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension). Trials, record NCT02537574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02537574
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
- NCT number
- NCT02537574
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 380 participants, actual
- Lead sponsor
- Alkermes, Inc.
- Conditions
- Opioid Use Disorder
- Interventions
- NTX/BUP, NTX/PBO-B, PBO-N/PBO-B
- First posted
- 2015-09-01
- Last updated
- 2019-03-06
- Results first posted
- 2019-01-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection | 1 week | Toleration to the injection was demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale \[COWS\] \</=12 or Subjective Opiate Withdrawal Scale \[SOWS\] \</=10) following VIVITROL administration. The COWS is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. The SOWS is a 16-item self-report questionnaire designed to measure the severity of opioid withdrawal symptoms. The subject rates the intensity of symptoms using a 5-point scale. The range of SOWS scores is 1-10 (mild); 11-20 (moderate); and 21-30 (severe). |
| Secondary | Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection | 1 week | The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. |
| Secondary | Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection | 1 week | The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. |
| Secondary | Area Under the Curve (AUC) COWS Score During the Treatment Period Prior to VIVITROL Injection | The COWS was administered 4-6 times per day during the Treatment Period (Days 1-7) | The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. To determine the daily AUC COWS score, a curve was generated by plotting the COWS scores against the time the test was taken. The area under this curve was calculated using the linear trapezoidal rule. For the total AUC COWS score, the AUCs calculated for each day during the treatment period were added together. To normalize for time, the total AUC COWS score was then divided by the number of days with daily AUC COWS score during the treatment period. The AUC COWS has a different range than the standard scale as it measures not the score itself, but the area under the curve of the score plotted against time. |
| Secondary | Mean Score for Desire of Opioids During Treatment Period Prior to VIVITROL Injection | 1 week | The Desire for Opioids Visual Analog Scale (VAS) uses a 100-mm, horizontal linear scale, with 0 anchored on the left representing "no desire for opioids" and 100 anchored on the right representing "strongest imaginable desire for opioids". Subjects placed a vertical line on the scale to indicate their desire for opioids at that particular time. |
| Secondary | Incidence of Adverse Effects | Up to 92 days | The number of subjects who experienced treatment-emergent Adverse Events. |
| Secondary | Area Under the Curve SOWS Score During the Treatment Period Prior to the VIVITROL Injection | The SOWS was administered 4-6 times per day during the Treatment Period | The Subjective Opiate Withdrawal Scale (SOWS) is a 16-item self-report questionnaire designed to measure the severity of opioid withdrawal symptoms. The subject rates the intensity of symptoms using a 5-point scale. The range of SOWS scores is 1-10 (mild); 11-20 (moderate); and 21-30 (severe). To determine the daily AUC SOWS score, a curve was generated by plotting the SOWS scores against the time the test was taken. The area under this curve was calculated using the linear trapezoidal rule. For the total AUC SOWS score, the AUCs calculated for each day during the treatment period were added together. To normalize for time, the total AUC SOWS score was then divided by the number of days with daily AUC SOWS score during the treatment period. The AUC SOWS has a different range than the standard scale as it measures not the score itself, but the area under the curve of the score plotted against time. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection | 1 week | The Full Analysis Set (FAS) includes all subjects in the Safety Population (randomized subjects who received at least 1 dose of study drug), excluding the second enrollment of duplicate subjects (those subjects who enrolled multiple times in the same study). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection | 1 week | The Full Analysis Set (FAS) included all subjects in the Safety Population (randomized subjects who received at least 1 dose of study drug), excluding the second enrollment of duplicate subjects (those subjects who enrolled multiple times in the same study). | Number of days | MEAN |
| SECONDARY | Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection | 1 week | The Full Analysis Set (FAS) included all subjects in the Safety Population (randomized subjects who received at least 1 dose of study drug), excluding the second enrollment of duplicate subjects (those subjects who enrolled multiple times in the same study). | score on a scale | MEAN |
| SECONDARY | Area Under the Curve (AUC) COWS Score During the Treatment Period Prior to VIVITROL Injection | The COWS was administered 4-6 times per day during the Treatment Period (Days 1-7) | All randomized subjects who received at least 1 dose of study drug and had 1 post-baseline COWS measurement. | Score on a scale | MEAN |
| SECONDARY | Mean Score for Desire of Opioids During Treatment Period Prior to VIVITROL Injection | 1 week | All randomized subjects who received at least 1 dose of study drug and provided at least 1 post-baseline measureable VAS assessment. | score on a scale | MEAN |
| SECONDARY | Incidence of Adverse Effects | Up to 92 days | The Safety Analysis Set was used to analyze this measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Area Under the Curve SOWS Score During the Treatment Period Prior to the VIVITROL Injection | The SOWS was administered 4-6 times per day during the Treatment Period | All randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline SOWS measurement. | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection | NTX/BUP | 57 | Participants | ||
| Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection | NTX/PBO-B | 51 | Participants | ||
| Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection | PBO-N/PBO-B | 57 | Participants | ||
| Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection | NTX/BUP | 5.0 | Standard Deviation 2.23 | Number of days | |
| Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection | NTX/PBO-B | 4.5 | Standard Deviation 2.50 | Number of days | |
| Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection | PBO-N/PBO-B | 5.4 | Standard Deviation 2.02 | Number of days | |
| Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection | NTX/BUP | 7.39 | Standard Deviation 3.726 | score on a scale | |
| Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection | NTX/PBO-B | 7.78 | Standard Deviation 3.981 | score on a scale | |
| Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection | PBO-N/PBO-B | 6.11 | Standard Deviation 3.044 | score on a scale | |
| Area Under the Curve (AUC) COWS Score During the Treatment Period Prior to VIVITROL Injection | NTX/BUP | 955.7 | Standard Deviation 535.38 | Score on a scale |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NTX/BUP | 126 | |
| Overall Study | STARTED | NTX/PBO-B | 126 | |
| Overall Study | STARTED | PBO-N/PBO-B | 126 | |
| Overall Study | COMPLETED | NTX/BUP | 27 | |
| Overall Study | COMPLETED | NTX/PBO-B | 23 | |
| Overall Study | COMPLETED | PBO-N/PBO-B | 18 | |
| Overall Study | NOT COMPLETED | NTX/BUP | 99 | |
| Overall Study | NOT COMPLETED | NTX/PBO-B | 103 | |
| Overall Study | NOT COMPLETED | PBO-N/PBO-B | 108 |
Source ClinicalTrials.gov
Adverse events24
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 | Diarrhoea | Gastrointestinal disorders | NTX/BUP | 7 | 126 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | NTX/PBO-B | 6 | 126 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | PBO-N/PBO-B | 9 | 126 | 11 |
| other | Nausea | Gastrointestinal disorders | NTX/BUP | 7 | 126 | 8 |
| other | Nausea | Gastrointestinal disorders | NTX/PBO-B | 4 | 126 | 4 |
| other | Nausea | Gastrointestinal disorders | PBO-N/PBO-B | 4 | 126 | 5 |
| other | Anxiety | Psychiatric disorders | NTX/BUP | 6 | 126 | 6 |
| other | Anxiety | Psychiatric disorders | NTX/PBO-B | 4 | 126 | 4 |
| other | Anxiety | Psychiatric disorders | PBO-N/PBO-B | 9 | 126 | 10 |
| serious | Panic Attack | Psychiatric disorders | NTX/BUP | 1 | 126 | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NTX/BUP | 0 | 126 |
| Total, all-cause mortality | NTX/PBO-B | 0 | 126 |
| Total, all-cause mortality | PBO-N/PBO-B | 0 | 126 |
| Total, other adverse events | NTX/BUP | 18 | 126 |
| Total, other adverse events | NTX/PBO-B | 12 | 126 |
| Total, other adverse events | PBO-N/PBO-B | 19 | 126 |
| Total, serious adverse events | NTX/BUP | 2 | 126 |
| Total, serious adverse events | NTX/PBO-B | 1 | 126 |
| Total, serious adverse events | PBO-N/PBO-B | 2 | 126 |
Source ClinicalTrials.gov
Papers2
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/NCT02537574
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