SchizophreniaPhase 2NCT02161718

A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder

A Phase 2 study testing Samidorphan + olanzapine (ALKS 3831) in people with Schizophrenia and Alcohol Use Disorder, run by Alkermes, Inc. at 71 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Alcohol Use Disorder
What is being tested?: Samidorphan + olanzapine (ALKS 3831)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: 71 sitesin 3 countries
Study dates: May 2014to 1 Feb 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has a BMI between 18.0 and 40.0 kg/m2, inclusive
Has a diagnosis of schizophrenia
Has a diagnosis of alcohol use disorder (AUD)
Has experienced an acute exacerbation of schizophrenia within the past 6 months
Additional criteria may apply

Who cannot join

Is pregnant or breastfeeding
Had first lifetime psychotic episode less than 1 year before screening or has experienced only a single lifetime psychotic episode
Has a known or suspected intolerance, allergy, or hypersensitivity to olanzapine
Has current or pending legal charges with the potential for incarceration
Has a positive drug screen for opiates
Additional criteria may apply

Trial locations and contacts

71 sites in 3 countries.

Country

City, postcode or hospital

71 sites in 3 countries

United States58 sites

Alkermes Investigational Site
Anaheim, California, 92805
Alkermes Investigational Site
Atlanta, Georgia, 30308
Alkermes Investigational Site
Augusta, Georgia, 30912
Alkermes Investigational Site
Austin, Texas, 78754
Alkermes Investigational Site
Bellevue, Washington, 98007
Alkermes Investigational Site
Cedarhurst, New York, 11516
Alkermes Investigational Site
Charleston, South Carolina, 29401
Alkermes Investigational Site
Charleston, South Carolina, 29407
Alkermes Investigational Site
Charleston, South Carolina, 29425
Alkermes Investigational Site
Chicago, Illinois, 60640
Alkermes Investigational Site
Claremont, New Hampshire, 03743
Alkermes Investigational Site
Creve Coeur, Missouri, 63141
Alkermes Investigational Site
Culver City, California, 90230
Alkermes Investigational Site
Dallas, Texas, 75214
Alkermes Investigational Site
Dayton, Ohio, 45417
Alkermes Investigational Site
Decatur, Georgia, 30030
Alkermes Investigational Site
DeSoto, Texas, 75115
Alkermes Investigational Site
Flowood, Mississippi, 39232
Alkermes Investigational Site
Fort Lauderdale, Florida, 33308
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
Hoffman Estates, Illinois, 60169
Alkermes Investigational Site
Irvine, California, 92617
Alkermes Investigational Site
Jamaica, New York, 11423
Alkermes Investigational Site
Kansas City, Missouri, 64108
Alkermes Investigational Site
La Jolla, California, 92037
Alkermes Investigational Site
Las Vegas, Nevada, 89102
Alkermes Investigational Site
Leesburg, Florida, 34748
Alkermes Investigational Site
Little Rock, Arkansas, 72211
Alkermes Investigational Site
Long Beach, California, 90822
Alkermes Investigational Site
Maitland, Florida, 32751
Alkermes Investigational Site
Miami, Florida, 33122
Alkermes Investigational Site
Miami, Florida, 33136
Alkermes Investigational Site
Nashua, New Hampshire, 03060
Alkermes Investigational Site
National City, California, 91950
Alkermes Investigational Site
Neptune City, New Jersey, 07753
Alkermes Investigational Site
New York, New York, 10021
Alkermes Investigational Site
New York, New York, 10032
Alkermes Investigational Site
New York, New York, 10035
Alkermes Investigational Site
North Miami, Florida, 33021
Alkermes Investigational Site
Oak Brook, Illinois, 60523
Alkermes Investigational Site
Oakland, California, 94612
Alkermes Investigational Site
Oakland Park, Florida, 33334
Alkermes Investigational Site
Oceanside, California, 92056
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73112
Alkermes Investigational Site
Orange, California, 92868
Alkermes Investigational Site
Orlando, Florida, 32803
Alkermes Investigational Site
Rochester, New York, 14642
Alkermes Investigational Site
San Diego, California, 92123
Alkermes Investigational Site
San Francisco, California, 94121
Alkermes Investigational Site
Scranton, Pennsylvania, 18503
Alkermes Investigational Site
Shreveport, Louisiana, 71101
Alkermes Investigational Site
Springdale, Arkansas, 72764
Alkermes Investigational Site
St Louis, Missouri, 63118
Alkermes Investigational Site
Staten Island, New York, 10312
Alkermes Investigational Site
Tampa, Florida, 33613
Alkermes Investigational Site
Torrance, California, 90502
Alkermes Investigational Site
Washington D.C., District of Columbia, 20016
Alkermes Investigational Site
Worcester, Massachusetts, 01605

Other trials in United States

Bulgaria9 sites

Alkermes Investigational Site
Burgas, 8000
Alkermes Investigational Site
Kazanlak, 6100
Alkermes Investigational Site
Lovech, 5500
Alkermes Investigational Site
Novi Iskar, 1282
Alkermes Investigational Site
Sofia, 1606
Alkermes Investigational Site
Tserova Koria, 8260
Alkermes Investigational Site
Varna, 9002
Alkermes Investigational Site
Varna, 9020
Alkermes Investigational Site
Vratsa, 3000

Other trials in Bulgaria

Poland4 sites

Alkermes Investigational Site
Bełchatów, 97-400
Alkermes Investigational Site
Bialystok, 15-464
Alkermes Investigational Site
Gdansk, 80-546
Alkermes Investigational Site
Lublin, 20-109

Other trials in Poland

About this study

Official title: A Phase 2, Efficacy, Safety and Tolerability Study of ALKS 3831 in Schizophrenia With Alcohol Use Disorder

This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).

Conditions: Schizophrenia, Alcohol Use Disorder
Being tested: Samidorphan + olanzapine (ALKS 3831), Placebo + olanzapine
Keywords: Alkermes, Schizophrenia, Alcohol Use Disorder, ALKS 3831
Medical subject headings: Schizophrenia, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Samidorphan + olanzapine (ALKS 3831)Drug
Oral tablet, taken once daily
Placebo + olanzapineDrug
Oral tablet, taken once daily

Study groups in NCT02161718
Study group	Role	What they receive
Samidorphan + olanzapine (ALKS 3831)	Experimental	Active study drug Receives: Drug: Samidorphan + olanzapine (ALKS 3831)
Placebo + olanzapine	Placebo comparator	Not described Receives: Drug: Placebo + olanzapine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS)
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
Measured: Up to 15 months

Secondary outcomes (2)

Number of Events of Exacerbation of Disease (EEDS)
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
Measured: Up to 15 months
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)
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
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 20141 Feb 2017

First posted12 Jun 2014 (estimated)
Study startMay 2014
Primary completion11 Jan 2017
Study completion1 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02161718
Sponsor's protocol ID: ALK3831-401
Status last verified: Sep 2021
First submitted: 28 May 2014
Last updated: 8 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Brunette MF, Correll CU, O'Malley SS, McDonnell D, DiPetrillo L, Jiang Y, Simmons A, Silverman BL, Citrome L, Green AI. Olanzapine Plus Samidorphan (ALKS 3831) in Schizophrenia and Comorbid Alcohol Use Disorder: A Phase 2, Randomized Clinical Trial. J Clin Psychiatry. 2020 Mar 10;81(2):19m12786. doi: 10.4088/JCP.19m12786.
PubMed 32160422

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Efficacy, Safety and Tolerability Study of ALKS 3831 in Schizophrenia With Alcohol Use Disorder
ClinicalTrials.gov ID: NCT02161718
Acronym / sponsor ID: ALK3831-401
Conditions: Schizophrenia, Alcohol Use Disorder
Keywords: Alkermes, Schizophrenia, Alcohol Use Disorder, ALKS 3831
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: May 2014 (actual)
Primary completion: 11 Jan 2017 (actual)
Study completion: 1 Feb 2017 (actual)
First posted: 12 Jun 2014 (estimated)
Results: Posted 8 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Samidorphan + olanzapine (ALKS 3831)	Experimental	Drug: Samidorphan + olanzapine (ALKS 3831)Active study drug
Placebo + olanzapine	Placebo comparator	Drug: Placebo + olanzapine

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Has a BMI between 18.0 and 40.0 kg/m2, inclusive
Has a diagnosis of schizophrenia
Has a diagnosis of alcohol use disorder (AUD)
Has experienced an acute exacerbation of schizophrenia within the past 6 months
Additional criteria may apply

Key exclusion criteria (6 listed)

Is pregnant or breastfeeding
Had first lifetime psychotic episode less than 1 year before screening or has experienced only a single lifetime psychotic episode
Has a known or suspected intolerance, allergy, or hypersensitivity to olanzapine
Has current or pending legal charges with the potential for incarceration
Has a positive drug screen for opiates

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Samidorphan + olanzapine (ALKS 3831)Oral tablet, taken once daily	Drug	Samidorphan + olanzapine (ALKS 3831)
Placebo + olanzapineOral tablet, taken once daily	Drug	Placebo + olanzapine

Primary outcome

Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS)
Time frame: 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

2 secondary outcomes

Number of Events of Exacerbation of Disease (EEDS)
Time frame: Up to 15 months
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)
Time frame: 24 weeks

Results and safety

Results posted to the registry on 8 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open-label ALKS 3831	255	234
ALKS 3831	0	0
Olanzapine + Placebo	0	0

Primary outcome: Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS)

Time frame: Up to 15 months. Count of participants. Unit: Participants

Measure	ALKS 3831 n = 112	Olanzapine + Placebo n = 117
Number of Subjects with IAC Adjudicated EEDS	25	29
Number of Subjects Censored	87	88

ALKS 3831 vs Olanzapine + Placebo: Hazard Ratio (HR): 0.91 (95% CI 0.53 to 1.56), p = 0.746, Log Rank

Population analysed: 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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open- Label ALKS 3831	4 of 255 (1.6%)	0 of 255 (0%)	0 of 255
Olanzapine + Placebo	12 of 117 (10.3%)	19 of 117 (16.2%)	1 of 117
ALKS 3831	7 of 112 (6.3%)	26 of 112 (23.2%)	1 of 112

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32160422Brunette MF, Correll CU, O'Malley SS, McDonnell D, DiPetrillo L, Jiang Y, Simmons A, Silverman BL, Citrome L, Green AI. Olanzapine Plus Samidorphan (ALKS 3831) in Schizophrenia and Comorbid Alcohol Use Disorder: A Phase 2, Randomized Clinical Trial. J Clin Psychiatry. 2020 Mar 10;81(2):19m12786. doi: 10.4088/JCP.19m12786.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David McDonnell, MD study director

Alkermes, Inc.

71 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Samidorphan + olanzapine (ALKS 3831) in people with Schizophrenia and Alcohol Use Disorder, run by Alkermes, Inc. at 71 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Bulgaria, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) (time frame: Up to 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02161718, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.