Advertisement

Topics

Pilot Study of Depot NTX in Homeless Veterans

2014-08-27 03:12:29 | BioPortfolio

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. 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.

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Conditions

Alcohol Dependence

Intervention

Depot naltrexone, Oral Naltrexone

Location

VA Medical Center, Providence
Providence
Rhode Island
United States
02908-4799

Status

Not yet recruiting

Source

Department of Veterans Affairs

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:29-0400

Clinical Trials [1327 Associated Clinical Trials listed on BioPortfolio]

Behavioral Naltrexone Therapy (BNT) for Promoting Adherence to Oral Naltrexone (BNT-oral) vs Extended Release Injectable Depot Naltrexone (Depot-BNT); a Randomized Trial. A Free Treatment for Opiate Abuse.

In pilot study now proposed, we plan to randomly assign 60 opioid dependent patients to the new model, Depot-BNT, or to BNT plus oral naltrexone for a 6-month trial. This will provide init...

Injectable Versus Oral Naltrexone Treatment of Alcohol Dependence In Serious Mental Illness (SMI)

The primary aim of this study is to determine the feasibility of long-acting injectable naltrexone administration in a clinical trial in patients with SMI who also have a diagnosis of alco...

Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence

The overall goal of this research project is to test the efficacy of a newly developed therapy, Behavioral Naltrexone Therapy (BNT), to enhance the success of naltrexone maintenance and lo...

Combination of Naltrexone and Baclofen for Alcohol Dependence:A Pilot Study.

The purpose of this research study is to learn about the use of a combination of two medications, baclofen and naltrexone, for the treatment of alcohol dependence in men and women ages 25-...

Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling

This study assessed whether naltrexone, an opioid antagonist, might be effective in reducing excessive gambling behavior in people who also drink heavily. The efficacy of naltrexone was ev...

PubMed Articles [7000 Associated PubMed Articles listed on BioPortfolio]

Implementation of a Process for Initiating Naltrexone in Patients Hospitalized for Alcohol Detoxification or Withdrawal.

Naltrexone trials have demonstrated improved outcomes for patients with alcohol use disorders. Hospital initiation of naltrexone has had limited study.

Co-administration of low-dose naltrexone and bupropion reduces alcohol drinking in alcohol-preferring (P) rats.

This study examined whether combining naltrexone (NTX) with bupropion (BUP) is more effective in reducing alcohol drinking in alcohol-preferring (P) rats with a genetic predisposition toward high volu...

Long-acting intramuscular naltrexone for opioid use disorder: Utilization and association with multi-morbidity nationally in the Veterans Health Administration.

Long acting intramuscular (IM) naltrexone is an effective treatment for opioid use disorder (OUD), but rates and correlates of its use have not been studied.

The Effectiveness of Injectable Extended-Release Naltrexone vs Daily Buprenorphine-Naloxone for Opioid Dependence: A Randomized Clinical Noninferiority Trial.

To date, extended-release naltrexone hydrochloride has not previously been compared directly with opioid medication treatment (OMT), currently the most commonly prescribed treatment for opioid depende...

Pharmacologically controlled drinking in the treatment of alcohol dependence or alcohol use disorders: a systematic review with direct and network meta-analyses on nalmefene, naltrexone, acamprosate, baclofen and topiramate.

Pharmacologically controlled drinking in the treatment of alcohol dependence or alcohol use disorders (AUDs) is an emerging concept. Our objective was to explore the comparative effectiveness of drugs...

Medical and Biotech [MESH] Definitions

Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.

A primary, chronic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. The disease is often progressive and fatal. It is characterized by impaired control over drinking, preoccupation with the drug alcohol, use of alcohol despite adverse consequences, and distortions in thinking, most notably denial. Each of these symptoms may be continuous or periodic. (Morse & Flavin for the Joint Commission of the National Council on Alcoholism and Drug Dependence and the American Society of Addiction Medicine to Study the Definition and Criteria for the Diagnosis of Alcoholism: in JAMA 1992;268:1012-4)

Strong dependence, both physiological and emotional, upon heroin.

Strong dependence, both physiological and emotional, upon morphine.

Substances interfering with the metabolism of ethyl alcohol, causing unpleasant side effects thought to discourage the drinking of alcoholic beverages. Alcohol deterrents are used in the treatment of alcoholism.

More From BioPortfolio on "Pilot Study of Depot NTX in Homeless Veterans"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Healthcare
Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...


Searches Linking to this Trial