Phase 3
Completed N=45
Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence
Source: ClinicalTrials.gov NCT01856712 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Retention Rate: Percentage of Participants Attended an Initial Behavioral Treatment Visit Within 2 Weeks of Hospital Discharge. — 23; 22 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-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 | — |
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
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. Informational only — not medical advice.