Pilot Study of Depot NTX in Homeless Veterans
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|ClinicalTrials.gov Identifier: NCT01155869|
Recruitment Status : Terminated (Poor enrollment)
First Posted : July 2, 2010
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Drug: Depot naltrexone Drug: Oral Naltrexone||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Pilot Study of Depot Naltrexone in Alcohol-Dependent, Homeless Veterans|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||June 2012|
Depot naltrexone (Vivitrol) 380 mg. IM monthly
Drug: Depot naltrexone
Depot naltrexone 380 mg. IM monthly
Other Name: Vivitrol
Active Comparator: Oral Naltrexone
Naltrexone 50 mg tablet PO daily
Drug: Oral Naltrexone
Naltrexone 50 mg tablet PO daily
Other Name: Revia
- 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.
- Treatment Participation [ Time Frame: 16 weeks ]Percentage of total during-treatment study visits attended. This serves as a proxy for the number of months of treatment participation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155869
|United States, Rhode Island|
|VA Medical Center, Providence|
|Providence, Rhode Island, United States, 02908-4799|
|Principal Investigator:||Peter D Friedmann, MD MPH||VA Medical Center, Providence|