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Phase 3 N=45 Randomized Treatment

Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence

Alcohol Dependence

Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Retention Rate: Percentage of Participants Attended an Initial Behavioral Treatment Visit Within 2 Weeks of Hospital Discharge. — 23; 22 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Naltrexone (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Wisconsin, Madison
Primary completion
Jan 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Retention Rate: Percentage of Participants Attended an Initial Behavioral Treatment Visit Within 2 Weeks of Hospital Discharge.
23; 22
SECONDARY
Percentage of Patients Attended Recommended Outpatient Substance Abuse Treatment
19; 18
SECONDARY
Percentage of Participants Adhered to Medication
14; 14
SECONDARY
Ongoing Alcohol Consumption
136.5; 114.5

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01856712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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