Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence

February 28, 2019 updated by: University of Wisconsin, Madison

Pharmacotherapeutic Intervention to Improve Treatment Engagement Among Alcohol-dependent Veterans After Hospital Discharge

The over-arching goal of the proposed project is to understand the impact of medication adherence upon engagement in behavioral treatment for alcohol use disorders. The proposed project is a pilot feasibility study of inpatient veterans with problem alcohol use at the William S. Middleton VA Hospital (Madison, WI). Participants will be randomized to one of two parallel study conditions: (1) an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone, or (2) a single 380 mg intramuscular injection of naltrexone administered prior to discharge and a second injection one month later. The central hypothesis is that hospital-administered injectable naltrexone, when compared to daily oral naltrexone taken at home, will reduce alcohol use in the days immediately following hospitalization. Injectable naltrexone has been efficacious vs. placebo in addition to behavioral treatment in several studies. However, it has yet to be examined in head-to-head comparison with oral naltrexone, or in the hospital setting as an intervention that might facilitate behavioral treatment follow up after discharge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed project is a pilot feasibility study of inpatient veterans with problem alcohol use at the William S. Middleton VA Hospital. The over-arching goal is to understand the impact of medication adherence upon engagement in behavioral treatment for alcohol use disorders. Participants will be randomized to one of two parallel study conditions: (1) an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone, or (2) a single 380 mg intramuscular injection of naltrexone (duration of action = 30 days) administered prior to discharge followed by a second injection one month later. The central hypothesis is that hospital-administered, long-acting injectable naltrexone, when compared to daily oral naltrexone, will reduce alcohol use in the days immediately following hospitalization. This reduced consumption, we hypothesize, will be followed by improved engagement in substance abuse treatment.

Primary Aim: Demonstrate the feasibility of the proposed recruitment methods and study design. This aim comprises two measures with corresponding goals: (1) Recruitment/enrollment-with a recruitment goal of 50 eligible and consenting subjects in an 8 month time period, and (2) Follow-up data collection with a goal of post-hospitalization follow-up data on no less than 70% of enrolled subjects.

Secondary Aims: As a pilot feasibility study, we may not anticipate sufficient power to attain statistical significance on patient-oriented outcome measures. However, it will be important for us to consider and to evaluate pertinent outcomes and potential moderators in order to (1) develop and fine-tune study design, and (2) determine effect sizes for primary outcomes so that we may calculate appropriate sample sizes for future larger study. As such, the secondary aims for the current study are:

  1. To compare injectable naltrexone study to oral naltrexone in terms of attendance to recommended outpatient substance abuse treatment. We hypothesize that injectable naltrexone will be associated with improved likelihood of attending initial visits for substance abuse treatment.
  2. To compare study arms in terms of ongoing alcohol consumption. We hypothesize that (1) improved medication adherence in the oral naltrexone arm and (2) assignment to injectable naltrexone will be associated with reduced alcohol consumption (number of heavy drinking days in the past 14 days) following hospital discharge.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • University of Wisconsin - Department of Family Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • diagnostic criteria for alcohol dependence or abuse
  • women of childbearing potential who have a negative screening urine pregnancy test and are willing to use reliable birth control methods throughout the duration of the study

Exclusion Criteria:

  • active or recently active (less than 1 year) opioid dependence or daily use of opioid analgesics
  • acute hepatitis or liver failure
  • pregnancy
  • women who are currently breastfeeding
  • active suicidality
  • inability to provide written informed consent as determined by study comprehension questions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: oral naltrexone
an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone
Drug: Naltrexone
Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.
Other Names:
  • Revia, Vivitrol
Experimental: injectable naltrexone
a single 380 mg intramuscular injection of naltrexone (duration of action = 30 days)prior to hospital discharge followed by a second injection one month later.
Drug: Naltrexone
Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.
Other Names:
  • Revia, Vivitrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention Rate: Percentage of Participants Attended an Initial Behavioral Treatment Visit Within 2 Weeks of Hospital Discharge.
Time Frame: 12 months
Retention rate was measured in terms of percentage of participants attended an initial behavioral treatment visit within 2 weeks of hospital discharge.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Attended Recommended Outpatient Substance Abuse Treatment
Time Frame: 12 months
Attendance to recommended outpatient substance abuse treatment will be compared between injectable naltrexone group and oral naltrexone group. Keeping patients engaged in treatment is desirable and is known to improve addiction-related outcomes.
12 months
Percentage of Participants Adhered to Medication
Time Frame: 12 months
Medication adherence was measured as percentage of participants who took ≥ 80% of daily naltrexone doses determined via pill counts. Adherence of daily medication will predict treatment engagement following hospital discharge.
12 months
Ongoing Alcohol Consumption
Time Frame: 12 months
To compare study arms in terms of ongoing alcohol consumption. We hypothesize that (1) improved medication adherence in the oral naltrexone arm and (2) assignment to injectable naltrexone will be associated with reduced alcohol consumption (number of heavy drinking days in the past 14 days) following hospital discharge.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Randall T Brown, MD PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (Estimate)

May 17, 2013

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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