Trial · NCT02161718
A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
NCT02161718, Phase 2, Completed, Alkermes, Inc.; results first posted 2021-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder. Trials, record NCT02161718. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02161718
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
- NCT number
- NCT02161718
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 300 participants, actual
- Lead sponsor
- Alkermes, Inc.
- Conditions
- Schizophrenia, Alcohol Use Disorder
- Interventions
- Samidorphan + olanzapine (ALKS 3831), Placebo + olanzapine
- First posted
- 2014-06-12
- Last updated
- 2021-10-08
- Results first posted
- 2021-10-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) | Up to 15 months | EEDS was defined as any of the following occurring during the double-blind period \& was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC): 1. Hospitalization (includes psychiatric\& treatment of alcohol intoxication/withdrawal) 2. \>= 25% or \>= 15 point increase from randomization in PANSS total score 3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following: 3a. Score \>= 5 for subjects at a 2nd ad hoc visit with a score \<=3 at randomization 3b. Score \>= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease |
| Secondary | Number of Events of Exacerbation of Disease (EEDS) | Up to 15 months | EEDS was defined as any of the following occurring during the double-blind period \& was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC): 1. Hospitalization(includes psychiatric \& treatment of alcohol intoxication/withdrawal) 2. \>= 25% or \>= 15 point increase from randomization in PANSS total score 3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following: 3a. Score \>= 5 for subjects at a 2nd ad hoc visit with a score \<=3 at randomization 3b. Score \>= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease |
| Secondary | Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27) | 24 weeks | Alcohol consumption per day = (total number of drinks x 14 gram) / (total number of days) WHO criteria for risk of alcohol consumption on a single drinking day: Abstinence- Males: 0 g; Females- 0 g Low Risk- Males: 1-40 g; Females: 1-20 g Medium Risk- Males: 41- 60 g; Females: 21- 40 g High Risk- Males: 61-100 g; Females: 41-60 g Very High Risk- Males: \>= 101 g; Females: \>= 61 g |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) | Up to 15 months | Efficacy analyses were carried out using the intent to treat (ITT) population, i.e. all randomized subjects who received at least one dose of study drug post-randomization | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Events of Exacerbation of Disease (EEDS) | Up to 15 months | Efficacy analyses were carried out using the intent to treat (ITT) population, i.e. all randomized subjects who received at least one dose of study drug post-randomization | Events | NUMBER |
| SECONDARY | Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27) | 24 weeks | Efficacy analyses were carried out using subjects from the intent to treat (ITT) population with postbaseline data on drinking habits. | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) | ALKS 3831 | Number of Subjects with IAC Adjudicated EEDS | 25 | Participants | |
| Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) | Olanzapine + Placebo | Number of Subjects with IAC Adjudicated EEDS | 29 | Participants | |
| Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) | ALKS 3831 | Number of Subjects Censored | 87 | Participants | |
| Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) | Olanzapine + Placebo | Number of Subjects Censored | 88 | Participants | |
| Number of Events of Exacerbation of Disease (EEDS) | ALKS 3831 | 35 | Events | ||
| Number of Events of Exacerbation of Disease (EEDS) | Olanzapine + Placebo | 49 | Events | ||
| Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27) | ALKS 3831 | >= 1 Level Decrease from Baseline | 45 | Participants | |
| Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27) | Olanzapine + Placebo | >= 1 Level Decrease from Baseline | 44 | Participants | |
| Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27) | ALKS 3831 | < 1 Level Decrease from Baseline | 66 | Participants | |
| Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27) | Olanzapine + Placebo | < 1 Level Decrease from Baseline | 72 | Participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-Label ALKS 3831 Period | STARTED | Open-label ALKS 3831 | 255 | |
| Open-Label ALKS 3831 Period | STARTED | ALKS 3831 | 0 | |
| Open-Label ALKS 3831 Period | STARTED | Olanzapine + Placebo | 0 | |
| Open-Label ALKS 3831 Period | COMPLETED | Open-label ALKS 3831 | 234 | |
| Open-Label ALKS 3831 Period | COMPLETED | ALKS 3831 | 0 | |
| Open-Label ALKS 3831 Period | COMPLETED | Olanzapine + Placebo | 0 | |
| Open-Label ALKS 3831 Period | NOT COMPLETED | Open-label ALKS 3831 | 21 | |
| Open-Label ALKS 3831 Period | NOT COMPLETED | ALKS 3831 | 0 | |
| Open-Label ALKS 3831 Period | NOT COMPLETED | Olanzapine + Placebo | 0 | |
| Post- Randomization Period | STARTED | Open-label ALKS 3831 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events63
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 | Weight increased | Investigations | Open- Label ALKS 3831 | 0 | 255 | |
| other | Weight increased | Investigations | Olanzapine + Placebo | 14 | 117 | |
| other | Weight increased | Investigations | ALKS 3831 | 16 | 112 | |
| other | Alanine aminotransferase increased | Investigations | Open- Label ALKS 3831 | 0 | 255 | |
| other | Alanine aminotransferase increased | Investigations | Olanzapine + Placebo | 0 | 117 | |
| other | Alanine aminotransferase increased | Investigations | ALKS 3831 | 6 | 112 | |
| other | Nasopharyngitis | Infections and infestations | Open- Label ALKS 3831 | 0 | 255 | |
| other | Nasopharyngitis | Infections and infestations | Olanzapine + Placebo | 5 | 117 | |
| other | Nasopharyngitis | Infections and infestations | ALKS 3831 | 7 | 112 | |
| serious | Parotitis | Infections and infestations | Open- Label ALKS 3831 | 0 | 255 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open- Label ALKS 3831 | 0 | 255 |
| Total, all-cause mortality | Olanzapine + Placebo | 1 | 117 |
| Total, all-cause mortality | ALKS 3831 | 1 | 112 |
| Total, other adverse events | Open- Label ALKS 3831 | 0 | 255 |
| Total, other adverse events | Olanzapine + Placebo | 19 | 117 |
| Total, other adverse events | ALKS 3831 | 26 | 112 |
| Total, serious adverse events | Open- Label ALKS 3831 | 4 | 255 |
| Total, serious adverse events | Olanzapine + Placebo | 12 | 117 |
| Total, serious adverse events | ALKS 3831 | 7 | 112 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32160422 | RESULT |
Source PubMed
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/NCT02161718
GET https://conductscience.org/api/trials/v1/NCT02161718/events?page=2