Alcohol DependencePhase 4NCT01155869
Pilot Study of Depot NTX in Homeless Veterans
A Phase 4 study testing Depot naltrexone and Oral Naltrexone in people with Alcohol Dependence, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Almost 200,000 veterans are homeless each night, about one-quarter to one-third of homeless adults in the U.S. Half need treatment for a substance use disorder, usually alcohol dependence, but sobriety is often required to access alcohol treatment and housing services. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Depot naltrexone and Oral Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jun 2012
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Homeless per the federal definition (HEARTH Act, 2009), which includes individuals who lack a fixed, regular, and adequate nighttime residence; and those who have a primary nighttime residence that is a supervised publicly or privately operated shelter designed to provide temporary accommodations (including welfare hotels, congregate shelters, and transitional housing); an institution that provides a temporary residence for individuals intended to be institutionalized; and/or a public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings (including doubled up with a friend or family member).
- Meet criteria for a DSM-IV diagnosis of alcohol abuse or dependence in the past year.
- Last reported drink between 12 hours and 12 months prior, and BAC by breathalyzer of .08 or less.
- Age between 18 and 64 years.
- Eligible to receive VA services.
- Willing to provide informed consent that will include all study procedures.
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- Those who report any opiate use in the past month must pass a naloxone challenge test (no sign of opiate withdrawal after IM injection of 0.8 mg naloxone).
- If female of childbearing potential -- must be using adequate contraception.
- Cognitively intact and showing no signs of delusional thought processes on the Short Blessed test (Callahan, 2002) and SCID checklist. Those with an untreated SMI and/or not capable of understanding the study due to an active cognitive impairment or delusional thought process will be excluded.
- Speak English sufficiently to understand instructions and assessments.
Who cannot join
- Untreated disorder that might make participation hazardous (e.g. untreated psychosis or bipolar disorder with mania on SCID checklist or significant suicide risk on Modified Scale of Suicidal Ideation (MSSI).
- Use of contraindicated medications such as an opioid for a documented diagnosis or opiate maintenance.
- Chronic pain condition or expected procedure during the study that is likely to require opioid analgesia.
- Contraindicated medical conditions including pregnancy/lactation; liver failure or liver function test levels greater than three times normal; glaucoma; prior adverse reaction to naltrexone; life expectancy of less than 6 months or medical condition that will likely require skilled nursing facility care) within 6 months.
- Stated plan to leave the area within 6 months of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Providence
Providence, Rhode Island, 02908-4799
About this study
Official title: Pilot Study of Depot Naltrexone in Alcohol-Dependent, Homeless Veterans
Almost 200,000 veterans are homeless each night, about one-quarter to one-third of homeless adults in the U.S. Half need treatment for a substance use disorder, usually alcohol dependence, but sobriety is often required to access alcohol treatment and housing services. A monthly injection of depot naltrexone is efficacious in reducing alcohol use, but it is expensive and restricted in many VA Medical Centers. Oral naltrexone is more available but seldom used because of adherence problems that limit effectiveness. This open-label pilot study would compare the effect of depot versus oral naltrexone to help twenty homeless, alcohol-dependent veterans decrease their drinking, achieve sobriety and qualify for housing services. This study's findings could expand access to effective medication-assisted alcohol treatment in the VA, and thus help homeless veterans with alcohol problems improve their drinking, housing status, and appropriate use of health services.
Read the detailed description
Anticipated Impacts on Veteran's Healthcare. Ending homelessness among veterans is a major priority for VA. Veterans represent between one in four and one in three homeless adults. Almost 200,000 veterans are homeless each night. Rhode Island has the second highest per capita concentration of homeless persons in the United States and an estimated 2,000 homeless veterans. Half report unmet service needs related to substance use disorders. The VA is a major service provider to homeless persons and has developed innovative housing assistance programs. However, sobriety is required to access many housing services. Effective medication-assisted treatment for the alcohol-dependent, homeless population could improve their substance use, health care utilization and housing stability. If depot naltrexone is a useful tool for engaging alcohol-dependent, homeless veterans in effective treatment, a definitive study showing its effect would lead to fewer restrictions on depot naltrexone on the VA formulary, and expand access to effective medication-assisted treatment.
Project Background/Rationale. A dearth of residential long-term rehabilitation beds makes an initial period of sobriety necessary in order for homeless persons to access needed transitional sheltering in order to participate in outpatient alcohol treatment. Many alcohol-dependent homeless veterans find it difficult to achieve a period of sobriety. Clinical trials suggest that depot naltrexone is more efficacious than placebo in improving alcohol consumption among alcohol-dependent subjects, but depot naltrexone is expensive and has limited availability in many VA Medical Centers. Oral naltrexone is widely available but seldom used. This work seeks to examine the effect of depot versus oral naltrexone to help homeless alcohol dependent veterans.
Project Objectives. This open-label pilot study will compare the effect of 16-weeks of depot versus oral naltrexone among housing-seeking, alcohol dependent, homeless veterans. Outcomes will include alcohol consumption, housing stability, emergency department and hospital utilization, and substance abuse treatment participation. These preliminary data will evaluate the feasibility and effect size to allow the design of a larger, more definitive study of whether, compared to the oral naltrexone condition, the depot naltrexone group will experience: greater proportion of days abstinent and fewer drinks per drinking day; shorter time to achieve 30 days sobriety; more improvement in housing stability; fewer emergency department visits and hospitalizations and greater attendance at substance abuse treatment (number of visits attended).
Project Methods. Over 5 months, 20 homeless, alcohol dependent veterans will be recruited from the waiting lists for transitional or permanent housing at the Providence VA Medical Center. Using block randomization to stratify by current duration of abstinence (less than 7 days vs. 7 or more days) and sheltering (doubled-up/unsheltered/emergency vs. transitional sheltered), subjects will be assigned to either injection with depot naltrexone 380 mg. monthly or oral naltrexone 50 mg daily for 16 weeks. All will have medical visits with medication management counseling every 4 weeks with during the treatment period. Referrals will be made to needed services in keeping with standard practice. Research assessments at baseline and every 4 weeks through week 24 will assess alcohol consumption through self-report on calendar-based interviews, breathalyzer and liver enzyme testing. Primary outcomes will be alcohol consumption and time from randomization-to-30-day-sobriety. Secondary outcomes will include housing stability (across 5 ordered categories), emergency department and hospital utilization, and alcohol treatment participation from administrative data, CPRS abstracting and self-report.
- Conditions
- Alcohol Dependence
- Being tested
- Depot naltrexone, Oral Naltrexone
- Keywords
- alcohol dependence, homelessness, naltrexone
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depot naltrexoneDrug
Also called Vivitrol
Depot naltrexone 380 mg. IM monthly
Oral NaltrexoneDrug
Also called Revia
Naltrexone 50 mg tablet PO daily
| Study group | Role | What they receive |
|---|---|---|
| XR-NTX | Experimental | Depot naltrexone (Vivitrol) 380 mg. IM monthly Receives: Drug: Depot naltrexone |
| Oral Naltrexone | Active comparator | Naltrexone 50 mg tablet PO daily Receives: Drug: Oral Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Weekly Self-reported Alcohol Consumption
Mean number of standard drinks per week during the 24 week study. A standard drink is any drink that contains about 14 grams of pure alcohol, e.g. 12 ounces of beer, 5 ounces of wine or 1.5 ounces of spirits.
Measured: 24 weeks
Secondary outcomes (1)
Treatment Participation
Percentage of total during-treatment study visits attended. This serves as a proxy for the number of months of treatment participation
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2011
- Study completionJun 2012
Why it stopped: Poor enrollment
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 DependenceStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Peter D Friedmann, MD MPH, Principal investigator, VA Medical Center, Providence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155869
- Sponsor's protocol ID
- PPO 10-079
- Status last verified
- Jun 2014
- First submitted
- 30 Jun 2010
- Last updated
- 17 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Friedmann PD, Mello D, Lonergan S, Bourgault C, O'Toole TP. Aversion to injection limits acceptability of extended-release naltrexone among homeless, alcohol-dependent patients. Subst Abus. 2013;34(2):94-6. doi: 10.1080/08897077.2012.763083.
PubMed 23577900
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Depot Naltrexone in Alcohol-Dependent, Homeless Veterans
- ClinicalTrials.gov ID
- NCT01155869
- Acronym / sponsor ID
- PPO 10-079
- Conditions
- Alcohol Dependence
- Keywords
- alcohol dependence, homelessness, naltrexone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Posted 17 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Almost 200,000 veterans are homeless each night, about one-quarter to one-third of homeless adults in the U.S. Half need treatment for a substance use disorder, usually alcohol dependence, but sobriety is often required to access alcohol treatment and housing services. A monthly injection of depot naltrexone is efficacious in reducing alcohol use, but it is expensive and restricted in many VA Medical Centers. Oral naltrexone is more available but seldom used because of adherence problems that limit effectiveness. This open-label pilot study would compare the effect of depot versus oral naltrexone to help twenty homeless, alcohol-dependent veterans decrease their drinking, achieve sobriety and qualify for housing services. This study's findings could expand access to effective medication-assisted alcohol treatment in the VA, and thus help homeless veterans with alcohol problems improve their drinking, housing status, and appropriate use of health services.
Detailed description
Anticipated Impacts on Veteran's Healthcare. Ending homelessness among veterans is a major priority for VA. Veterans represent between one in four and one in three homeless adults. Almost 200,000 veterans are homeless each night. Rhode Island has the second highest per capita concentration of homeless persons in the United States and an estimated 2,000 homeless veterans. Half report unmet service needs related to substance use disorders. The VA is a major service provider to homeless persons and has developed innovative housing assistance programs. However, sobriety is required to access many housing services. Effective medication-assisted treatment for the alcohol-dependent, homeless population could improve their substance use, health care utilization and housing stability. If depot naltrexone is a useful tool for engaging alcohol-dependent, homeless veterans in effective treatment, a definitive study showing its effect would lead to fewer restrictions on depot naltrexone on the VA formulary, and expand access to effective medication-assisted treatment.
Project Background/Rationale. A dearth of residential long-term rehabilitation beds makes an initial period of sobriety necessary in order for homeless persons to access needed transitional sheltering in order to participate in outpatient alcohol treatment. Many alcohol-dependent homeless veterans find it difficult to achieve a period of sobriety. Clinical trials suggest that depot naltrexone is more efficacious than placebo in improving alcohol consumption among alcohol-dependent subjects, but depot naltrexone is expensive and has limited availability in many VA Medical Centers. Oral naltrexone is widely available but seldom used. This work seeks to examine the effect of depot versus oral naltrexone to help homeless alcohol dependent veterans.
Project Objectives. This open-label pilot study will compare the effect of 16-weeks of depot versus oral naltrexone among housing-seeking, alcohol dependent, homeless veterans. Outcomes will include alcohol consumption, housing stability, emergency department and hospital utilization, and substance abuse treatment participation. These preliminary data will evaluate the feasibility and effect size to allow the design of a larger, more definitive study of whether, compared to the oral naltrexone condition, the depot naltrexone group will experience: greater proportion of days abstinent and fewer drinks per drinking day; shorter time to achieve 30 days sobriety; more improvement in housing stability; fewer emergency department visits and hospitalizations and greater attendance at substance abuse treatment (number of visits attended).
Project Methods. Over 5 months, 20 homeless, alcohol dependent veterans will be recruited from the waiting lists for transitional or permanent housing at the Providence VA Medical Center. Using block randomization to stratify by current duration of abstinence (less than 7 days vs. 7 or more days) and sheltering (doubled-up/unsheltered/emergency vs. transitional sheltered), subjects will be assigned to either injection with depot naltrexone 380 mg. monthly or oral naltrexone 50 mg daily for 16 weeks. All will have medical visits with medication management counseling every 4 weeks with during the treatment period. Referrals will be made to needed services in keeping with standard practice. Research assessments at baseline and every 4 weeks through week 24 will assess alcohol consumption through self-report on calendar-based interviews, breathalyzer and liver enzyme testing. Primary outcomes will be alcohol consumption and time from randomization-to-30-day-sobriety. Secondary outcomes will include housing stability (across 5 ordered categories), emergency department and hospital utilization, and alcohol treatment participation from administrative data, CPRS abstracting and self-report.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XR-NTX | Experimental | Drug: Depot naltrexoneDepot naltrexone (Vivitrol) 380 mg. IM monthly |
| Oral Naltrexone | Active comparator | Drug: Oral NaltrexoneNaltrexone 50 mg tablet PO daily |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Homeless per the federal definition (HEARTH Act, 2009), which includes individuals who lack a fixed, regular, and adequate nighttime residence; and those who have a primary nighttime residence that is a supervised publicly or privately operated shelter designed to provide temporary accommodations (including welfare hotels, congregate shelters, and transitional housing); an institution that provides a temporary residence for individuals intended to be institutionalized; and/or a public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings (including doubled up with a friend or family member).
- Meet criteria for a DSM-IV diagnosis of alcohol abuse or dependence in the past year.
- Last reported drink between 12 hours and 12 months prior, and BAC by breathalyzer of .08 or less.
- Age between 18 and 64 years.
- Eligible to receive VA services.
Key exclusion criteria (5 listed)
- Untreated disorder that might make participation hazardous (e.g. untreated psychosis or bipolar disorder with mania on SCID checklist or significant suicide risk on Modified Scale of Suicidal Ideation (MSSI).
- Use of contraindicated medications such as an opioid for a documented diagnosis or opiate maintenance.
- Chronic pain condition or expected procedure during the study that is likely to require opioid analgesia.
- Contraindicated medical conditions including pregnancy/lactation; liver failure or liver function test levels greater than three times normal; glaucoma; prior adverse reaction to naltrexone; life expectancy of less than 6 months or medical condition that will likely require skilled nursing facility care) within 6 months.
- Stated plan to leave the area within 6 months of enrollment.
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 |
|---|---|---|
| Depot naltrexoneAlso: VivitrolDepot naltrexone 380 mg. IM monthly | Drug | XR-NTX |
| Oral NaltrexoneAlso: ReviaNaltrexone 50 mg tablet PO daily | Drug | Oral Naltrexone |
Primary outcome
Mean Weekly Self-reported Alcohol Consumption
Time frame: 24 weeks
Mean number of standard drinks per week during the 24 week study. A standard drink is any drink that contains about 14 grams of pure alcohol, e.g. 12 ounces of beer, 5 ounces of wine or 1.5 ounces of spirits.
1 secondary outcome
Treatment Participation
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23577900Friedmann PD, Mello D, Lonergan S, Bourgault C, O'Toole TP. Aversion to injection limits acceptability of extended-release naltrexone among homeless, alcohol-dependent patients. Subst Abus. 2013;34(2):94-6. doi: 10.1080/08897077.2012.763083.
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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.
Peter D Friedmann, MD MPH principal investigator
VA Medical Center, Providence
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 Depot naltrexone and Oral Naltrexone in people with Alcohol Dependence, run by US Department of Veterans Affairs 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 10 inclusion and 5 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 17 Jul 2014. 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 17 Jul 2014). 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?
Mean Weekly Self-reported Alcohol Consumption (time frame: 24 weeks). 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 NCT01155869, 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 17 Jul 2014.