Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence

NCT01856712 | Completed Phase 3 Results

• 1 other identifier: 2012-0702
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Dependence

Keywords

alcohol; veterans

Outcome Measures

Primary Outcomes (1)

• Retention Rate: Percentage of Participants Attended an Initial Behavioral Treatment Visit Within 2 Weeks of Hospital Discharge.

  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 Outcomes (3)

• Percentage of Patients Attended Recommended Outpatient Substance Abuse Treatment

  12 months

• Percentage of Participants Adhered to Medication

  12 months

• Ongoing Alcohol Consumption

  12 months

Study Arms (2)

oral naltrexone

ACTIVE COMPARATOR

an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone

Drug: Naltrexone

injectable naltrexone

EXPERIMENTAL

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

Interventions

Naltrexone DRUG

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.

Also known as: Revia, Vivitrol

injectable naltrexone; oral naltrexone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Department of Family Medicine

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone; vivitrol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Randall Brown
• Organization: University of Wisconsin

rtbrown@wisc.edu

6082636558

Study Officials

• Randall T Brown, MD PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 17, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 5, 2019
• Results First Posted: March 5, 2019

Record last verified: 2019-02

Locations

US (1)