Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01856712 · ClinicalTrials.gov registry record · Phase 3
Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence
A Phase 3 study of Alcohol Dependence, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 3
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT01856712 is a Phase 3 study of Alcohol Dependence that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 54 participants, below the 313-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01856712, a Phase 3 study of Alcohol Dependence, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Naltrexone
Study Locations (1)
Wisconsin
- University of Wisconsin - Department of Family Medicine - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01856712
The ClinicalTrials.gov registry entry for NCT01856712 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 313-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (83% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alcohol Dependence appearing as the primary indexed condition, and to 1 intervention - of which Naltrexone is the first listed.
NCT01856712 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01856712 about?
NCT01856712 is a clinical study titled "Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence". 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 Hospita...
What is the current status of trial NCT01856712?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2013-05. Estimated completion is 2016-01.
What conditions does trial NCT01856712 study?
This clinical trial studies the following conditions: Alcohol Dependence.
What interventions are being tested in trial NCT01856712?
The interventions under investigation include: Naltrexone (DRUG).
Who is sponsoring clinical trial NCT01856712?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01856712 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Dependence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Prazosin for Treatment of Patients With Alcohol Dependence (AD) and Post Traumatic Stress Disorder (PTSD).
COMPLETED · Phase 3
-
Making Alcoholics Anonymous Easier
COMPLETED · Phase 3
-
The Impact of Heavy Alcohol Use on Saliva and Oral Health
RECRUITING
-
Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial
RECRUITING · Phase 2
-
Characterization Imaging Instruments in Alcoholics and Non-Alcoholics
RECRUITING
-
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment of Alcohol Use Disorder (AUD)
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.