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: Completed Phase 3 study of Alcohol Dependence, sponsored by University of Wisconsin, Madison.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Retention rate was measured in terms of percentage of participants attended an initial behavioral treatment visit within 2 weeks of hospital 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 |
What the finished NCT01856712 record still lists
NCT01856712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 313-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (83% lower).
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 a single indexed study location in 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.
Where NCT01856712's enrollment target sits among peer trials
54 32nd of 43 higher than 12 of 43 other Alcohol Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Dependence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01269853 · 54 participants · Phase 1
Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA
- NCT02390752 · 54 participants · Phase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
- NCT02991248 · 54 participants · NA
Improve Dynamic Lateral Balance of Humans With SCI
- NCT02993900 · 54 participants · NA
Image-Guided Gynecologic Brachytherapy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia