Trial · NCT02696434
Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
NCT02696434, Phase 3, Completed, Alkermes, Inc.; results first posted 2019-02-12
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL. Trials, record NCT02696434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02696434
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
- NCT number
- NCT02696434
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 101 participants, actual
- Lead sponsor
- Alkermes, Inc.
- Conditions
- Opioid Use Disorder
- Interventions
- Naltrexone, Placebo, Buprenorphine
- First posted
- 2016-03-02
- Last updated
- 2019-02-12
- Results first posted
- 2019-02-12
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 on Day 8 | 8 days | 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 </=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 | Proportion of Post-VIVITROL Days (Days 9-11) in Which Subjects in Each Group Demonstrate Mild Opioid Withdrawal | Days 9-11 | COWS score \</=12; 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 Scores During the Treatment Period (Days 1/1a-7) | Up to 7 days | 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) for COWS Scores During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period | The COWS was administered 4-6 times per day during the Treatment Period | 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). The daily AUC COWS score is derived based on the actual time (unit in minutes) COWS administered on each day by using the linear trapezoidal rule, and then divided by the COWS administration duration (last COWS administration time minus first COWS administration time) for that day. The normalized AUC COWS score is the summation of daily AUC COWS score during the relevant period divided by the number of days with daily AUC COWS score. |
| Secondary | Mean Score for "Desire for Opioids" Visual Analog Scale (VAS) During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period | Up to 11 days | The Desire for Opioids 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." |
| Secondary | Incidence of Adverse Events (AEs) | Up to 42 days | Number and percentage of subjects who experienced AEs. |
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 on Day 8 | 8 days | There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. This subject is categorized in the PBO NTX+BUP arm in the participant flow and safety analyses, but in the efficacy analyses the subject is categorized as NTX+BUP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Days With COWS Peak Score </=12 During the Treatment Period Prior to the VIVITROL Injection | 1 week | There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. This subject is categorized in the PBO NTX+BUP arm in the participant flow and safety analyses, but in the efficacy analyses the subject is categorized as NTX+BUP. | Days | MEAN |
| SECONDARY | Proportion of Post-VIVITROL Days (Days 9-11) in Which Subjects in Each Group Demonstrate Mild Opioid Withdrawal | Days 9-11 | There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. This subject is categorized in the PBO NTX+BUP arm in the participant flow and safety analyses, but in the efficacy analyses the subject is categorized as NTX+BUP. | Days | MEAN |
| SECONDARY | Mean Peak COWS Scores During the Treatment Period (Days 1/1a-7) | Up to 7 days | There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. This subject is categorized in the PBO NTX+BUP arm in the participant flow and safety analyses, but in the efficacy analyses the subject is categorized as NTX+BUP. | score on a scale | MEAN |
| SECONDARY | Area Under the Curve (AUC) for COWS Scores During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period | The COWS was administered 4-6 times per day during the Treatment Period | There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. This subject is categorized in the PBO NTX+BUP arm in the participant flow and safety analyses, but in the efficacy analyses the subject is categorized as NTX+BUP. | score on a scale | MEAN |
| SECONDARY | Mean Score for Desire for Opioids Visual Analog Scale (VAS) During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period | Up to 11 days | 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 Events (AEs) | Up to 42 days | There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. All the efficacy analyses are summarized by the planned treatment assignment, and all the safety analyses are summarized by actual treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
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 on Day 8 | NTX + BUP | 35 | Participants | ||
| Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8 | PBO NTX + BUP | 38 | Participants | ||
| Proportion of Days With COWS Peak Score </=12 During the Treatment Period Prior to the VIVITROL Injection | NTX + BUP | 5.8 | Standard Deviation 1.61 | Days | |
| Proportion of Days With COWS Peak Score </=12 During the Treatment Period Prior to the VIVITROL Injection | PBO NTX + BUP | 6.3 | Standard Deviation 1.36 | Days | |
| Proportion of Post-VIVITROL Days (Days 9-11) in Which Subjects in Each Group Demonstrate Mild Opioid Withdrawal | NTX + BUP | 2.4 | Standard Deviation 0.87 | Days | |
| Proportion of Post-VIVITROL Days (Days 9-11) in Which Subjects in Each Group Demonstrate Mild Opioid Withdrawal | PBO NTX + BUP | 2.6 | Standard Deviation 0.81 | Days | |
| Mean Peak COWS Scores During the Treatment Period (Days 1/1a-7) | NTX + BUP | 6.0 | Standard Deviation 3.71 | score on a scale | |
| Mean Peak COWS Scores During the Treatment Period (Days 1/1a-7) | PBO NTX + BUP | 5.0 | Standard Deviation 2.78 | score on a scale | |
| Area Under the Curve (AUC) for COWS Scores During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period | NTX + BUP | 4.5 | Standard Deviation 3.11 | score on a scale | |
| Area Under the Curve (AUC) for COWS Scores During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period | PBO NTX + BUP | 3.9 | Standard Deviation 2.29 | score on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NTX + BUP | 50 | |
| Overall Study | STARTED | PBO NTX + BUP | 51 | |
| Overall Study | COMPLETED | NTX + BUP | 28 | |
| Overall Study | COMPLETED | PBO NTX + BUP | 33 | |
| Overall Study | NOT COMPLETED | NTX + BUP | 22 | |
| Overall Study | NOT COMPLETED | PBO NTX + BUP | 18 |
Source ClinicalTrials.gov
Adverse events38
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 | Anxiety | Psychiatric disorders | NTX + BUP | 15 | 50 | 15 |
| other | Anxiety | Psychiatric disorders | PBO NTX + BUP | 15 | 51 | 15 |
| other | Insomnia | Psychiatric disorders | NTX + BUP | 13 | 50 | 14 |
| other | Insomnia | Psychiatric disorders | PBO NTX + BUP | 13 | 51 | 13 |
| other | Restlessness | Psychiatric disorders | NTX + BUP | 4 | 50 | 4 |
| other | Restlessness | Psychiatric disorders | PBO NTX + BUP | 5 | 51 | 5 |
| other | Drug Withdrawal Syndrome | Psychiatric disorders | NTX + BUP | 3 | 50 | 5 |
| other | Drug Withdrawal Syndrome | Psychiatric disorders | PBO NTX + BUP | 2 | 51 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | NTX + BUP | 16 | 50 | 16 |
| other | Diarrhoea | Gastrointestinal disorders | PBO NTX + BUP | 9 | 51 | 9 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NTX + BUP | 0 | 50 |
| Total, all-cause mortality | PBO NTX + BUP | 0 | 51 |
| Total, other adverse events | NTX + BUP | 36 | 50 |
| Total, other adverse events | PBO NTX + BUP | 34 | 51 |
| Total, serious adverse events | NTX + BUP | 0 | 50 |
| Total, serious adverse events | PBO NTX + BUP | 1 | 51 |
Source ClinicalTrials.gov
Papers3
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NTX + BUP vs PBO NTX + BUP: Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8 | Trial comparisons |
| NTX + BUP vs PBO NTX + BUP: Incidence of Adverse Events (AEs) | Trial comparisons |
| NTX + BUP vs PBO NTX + BUP: deaths from any cause | Trial comparisons |
| NTX + BUP vs PBO NTX + BUP: 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/NCT02696434
GET https://conductscience.org/api/trials/v1/NCT02696434/events?page=2