Alcohol Use DisorderPhase 4NCT04094584
Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder
A Phase 4 study testing Vivitrol (Extended Release Naltrexone) in people with Alcohol Use Disorder and Substance Use, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a phase 4, open-label, feasibility study of extended release naltrexone (Vivitrol, Alkermes Pharmaceutical) and case management for treatment of alcohol use disorders in the ED. Excess alcohol use is a major cause of morbidity and mortality and contributes to a large number of emergency department (ED) visits. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Use Disorder, Substance Use, Alcohol Abuse or Dependence
- What is being tested?
- Vivitrol (Extended Release Naltrexone)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2020to 1 May 2022
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active alcohol use by self-report
- Known alcohol use disorder or suspected alcohol use disorder and Alcohol Use Disorders Identification Test (AUDIT) score ≥ 8 or AUDIT-C score > 4, or frequent emergency department visits and hazardous drinking defined as: At least 3 emergency department visits in the past 12 months, including the index visit, and Alcohol Use Disorders Identification Test (AUDIT) score ≥ 8 or AUDIT-C score > 4
Who cannot join
- Opioid use: currently receiving opioid analgesics, self-report of opioid use in past 7 days, current physiologic opioid dependence, patients in acute opioid withdrawal, urine toxicology screen positive for opiates including fentanyl
- History of hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent
- Liver function tests (AST, ALT) > 5x upper limit of normal or known cirrhosis
- Platelets less than 100,000 per cubic mm
- Acute condition at the time of enrollment that necessitates medical therapy with opioids
- Pregnant
- Incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94122
About this study
Official title: Feasibility of Emergency Department Initiated Extended-Release Naltrexone and Case Management Services for the Treatment of Alcohol Use Disorder
This is a phase 4, open-label, feasibility study of extended release naltrexone (Vivitrol, Alkermes Pharmaceutical) and case management for treatment of alcohol use disorders in the ED.
Excess alcohol use is a major cause of morbidity and mortality and contributes to a large number of emergency department (ED) visits. The rate of alcohol-related ED visits is increasing, and there is evidence that this increase may be driven by a subset of patients who frequently visit the ED due to an underlying alcohol use disorder (AUD). The proposed study will assess the feasibility of implementing a multimodal treatment for AUD in the emergency department for 25 patients with AUD. The rationale for including each component of the multimodal treatment is outlined below.
Read more
Pharmacotherapy is recommended as the standard of care for alcohol use disorders. Of the four drugs approved by the FDA for treatment of alcohol use disorder, extended release naltrexone has been found to be superior at reducing healthcare utilization, increasing detoxification facility use, and reducing total cost. Fewer than 1 in 4 patients with AUD currently receives treatment with an FDA approved agent and use of these drugs in EDs is virtually non-existent.
ED patients with alcohol use disorders frequently suffer from multiple medical, mental health, and social problems that influence their health. Providing such patients with case management services has shown promise in improving health related outcomes while curbing ED utilization and healthcare costs.
Regardless of comorbidity, limited access to substance use and mental health services is a significant barrier to receiving treatment, and large disparities exist in access based on income level. Facilitated referrals, where a healthcare worker communicates with the patient and service providers and assists the patient with obtaining follow up, have been used effectively to improve access to specialty care after ED discharge. Case managers are familiar with community treatment resources and are well versed in providing facilitated referrals.
The primary hypothesis is that implementing this multimodal treatment will be feasible in an ED setting and will reduce alcohol use. Feasibility measures (recruitment, retention, continuation of treatment after the trial) are the primary outcomes. The intent of the intervention is to change drinking behavior in a way that benefits participants' health and quality of life. As such, we will conduct a limited efficacy assessment. Treatment efficacy will be assessed by comparing alcohol consumption, quality of life, and life consequences related to alcohol use before and after the intervention.
The primary efficacy outcome is change in total alcohol consumption measured by a 2 week timeline follow back. Change from baseline will be assessed after the 3 month intervention period, and at the conclusion of the study follow up period for all outcomes.
- Being tested
- Vivitrol (Extended Release Naltrexone)
- Keywords
- Emergency Department, Naltrexone
- Medical subject headings
- Alcoholism, Substance-Related Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivitrol (Extended Release Naltrexone)Drug
Also called Case Management, SBIRT
Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Intervention | Experimental | The intervention is multimodal and consists of:
1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months.
2. Case Management services Receives: Drug: Vivitrol (Extended Release Naltrexone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Retained in Study at 3 Months
Percentage of enrolled participants who attend final study visit at the end of the intervention period
Measured: 3 months
Retention at 12 Months
Percentage of enrolled participants who complete final study visit at the end of the follow up periods
Measured: 12 months
Change in Daily Total Alcohol Consumption From Baseline at 3 Months
Self-reported total daily alcohol consumption at 3 months, compared to baseline
Measured: 3 months after enrollment
Change in Total Alcohol Consumption at 12 Months
Change in self-reported total daily alcohol consumption from baseline
Measured: 12 months after enrollment
Secondary outcomes (1)
Change in Quality of Life Score at 3 Months
Kemp Quality of Life score at 3 months compared to baseline. Score is 1-7 with higher scores indicating higher quality of life.
Measured: 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start14 Aug 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Why it stopped: 12 month follow up data not collected due to pandemic disruptions
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 Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Carestar Foundation
- Responsible party
- Sponsor
- Investigators
- Maria Raven, MD, Principal investigator, University of California, San FranciscoCharles E Murphy IV, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094584
- Sponsor's protocol ID
- 18-26090
- Status last verified
- May 2023
- First submitted
- 17 Sep 2019
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murphy CE 4th, Coralic Z, Wang RC, Montoy JCC, Ramirez B, Raven MC. Extended-Release Naltrexone and Case Management for Treatment of Alcohol Use Disorder in the Emergency Department. Ann Emerg Med. 2023 Apr;81(4):440-449. doi: 10.1016/j.annemergmed.2022.08.453. Epub 2022 Oct 31.
PubMed 36328851
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Emergency Department Initiated Extended-Release Naltrexone and Case Management Services for the Treatment of Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04094584
- Acronym / sponsor ID
- 18-26090
- Keywords
- Emergency Department, Naltrexone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 12 month follow up data not collected due to pandemic disruptions
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Carestar Foundation
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 4, open-label, feasibility study of extended release naltrexone (Vivitrol, Alkermes Pharmaceutical) and case management for treatment of alcohol use disorders in the ED.
Excess alcohol use is a major cause of morbidity and mortality and contributes to a large number of emergency department (ED) visits. The rate of alcohol-related ED visits is increasing, and there is evidence that this increase may be driven by a subset of patients who frequently visit the ED due to an underlying alcohol use disorder (AUD). The proposed study will assess the feasibility of implementing a multimodal treatment for AUD in the emergency department for 25 patients with AUD. The rationale for including each component of the multimodal treatment is outlined below.
Pharmacotherapy is recommended as the standard of care for alcohol use disorders. Of the four drugs approved by the FDA for treatment of alcohol use disorder, extended release naltrexone has been found to be superior at reducing healthcare utilization, increasing detoxification facility use, and reducing total cost. Fewer than 1 in 4 patients with AUD currently receives treatment with an FDA approved agent and use of these drugs in EDs is virtually non-existent.
ED patients with alcohol use disorders frequently suffer from multiple medical, mental health, and social problems that influence their health. Providing such patients with case management services has shown promise in improving health related outcomes while curbing ED utilization and healthcare costs.
Regardless of comorbidity, limited access to substance use and mental health services is a significant barrier to receiving treatment, and large disparities exist in access based on income level. Facilitated referrals, where a healthcare worker communicates with the patient and service providers and assists the patient with obtaining follow up, have been used effectively to improve access to specialty care after ED discharge. Case managers are familiar with community treatment resources and are well versed in providing facilitated referrals.
The primary hypothesis is that implementing this multimodal treatment will be feasible in an ED setting and will reduce alcohol use. Feasibility measures (recruitment, retention, continuation of treatment after the trial) are the primary outcomes. The intent of the intervention is to change drinking behavior in a way that benefits participants' health and quality of life. As such, we will conduct a limited efficacy assessment. Treatment efficacy will be assessed by comparing alcohol consumption, quality of life, and life consequences related to alcohol use before and after the intervention.
The primary efficacy outcome is change in total alcohol consumption measured by a 2 week timeline follow back. Change from baseline will be assessed after the 3 month intervention period, and at the conclusion of the study follow up period for all outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Intervention | Experimental | Drug: Vivitrol (Extended Release Naltrexone)The intervention is multimodal and consists of: 1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months. 2. Case Management services |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Active alcohol use by self-report
- Known alcohol use disorder or suspected alcohol use disorder and Alcohol Use Disorders Identification Test (AUDIT) score ≥ 8 or AUDIT-C score > 4, or frequent emergency department visits and hazardous drinking defined as: At least 3 emergency department visits in the past 12 months, including the index visit, and Alcohol Use Disorders Identification Test (AUDIT) score ≥ 8 or AUDIT-C score > 4
Key exclusion criteria (7 listed)
- Opioid use: currently receiving opioid analgesics, self-report of opioid use in past 7 days, current physiologic opioid dependence, patients in acute opioid withdrawal, urine toxicology screen positive for opiates including fentanyl
- History of hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent
- Liver function tests (AST, ALT) > 5x upper limit of normal or known cirrhosis
- Platelets less than 100,000 per cubic mm
- Acute condition at the time of enrollment that necessitates medical therapy with opioids
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 |
|---|---|---|
| Vivitrol (Extended Release Naltrexone)Also: Case Management, SBIRTMonthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant | Drug | Multimodal Intervention |
Primary outcome
Participants Retained in Study at 3 Months
Time frame: 3 months
Percentage of enrolled participants who attend final study visit at the end of the intervention period
Retention at 12 Months
Time frame: 12 months
Percentage of enrolled participants who complete final study visit at the end of the follow up periods
Change in Daily Total Alcohol Consumption From Baseline at 3 Months
Time frame: 3 months after enrollment
Self-reported total daily alcohol consumption at 3 months, compared to baseline
Change in Total Alcohol Consumption at 12 Months
Time frame: 12 months after enrollment
Change in self-reported total daily alcohol consumption from baseline
1 secondary outcome
Change in Quality of Life Score at 3 Months
Time frame: 3 months after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36328851Murphy CE 4th, Coralic Z, Wang RC, Montoy JCC, Ramirez B, Raven MC. Extended-Release Naltrexone and Case Management for Treatment of Alcohol Use Disorder in the Emergency Department. Ann Emerg Med. 2023 Apr;81(4):440-449. doi: 10.1016/j.annemergmed.2022.08.453. Epub 2022 Oct 31.
- Individual participant dataSharing planned: No
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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.
Maria Raven, MD principal investigator
University of California, San Francisco
Charles E Murphy IV, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vivitrol (Extended Release Naltrexone) in people with Alcohol Use Disorder and Substance Use, run by University of California, San Francisco at 1 site in United States.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 22 Jun 2023). 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?
Participants Retained in Study at 3 Months (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT04094584, 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 22 Jun 2023.