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NCT01437046 · ClinicalTrials.gov registry record · Early Phase 1

Doxazosin an a1 Antagonist for Alcohol Dependence

A Early Phase 1 study, sponsored by Brown University.

Completed
Registry status
Early Phase 1
Development phase
41
Enrollment target

NCT01437046: Completed Early Phase 1 study, sponsored by Brown University.

NCT01437046 is a Early Phase 1 study that has completed, run by Brown University. The registered enrollment target is 41 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01437046, a Early Phase 1 study, has completed, sponsored by Brown University.

COMPLETED
Registry status
Early Phase 1
Development phase
41 participants
Enrollment target

Study Summary

Norepinephrine system represents an important treatment target for alcohol dependence (AD) and the α1 -blocker prazosin may reduce alcohol drinking in rodents and alcoholic patients. The α1 -blocker doxazosin demonstrates a more favorable pharmacokinetic profile than prazosin, but has never been studied for AD. A double-blind placebo-controlled randomized clinical trial was designed in AD individuals seeking outpatient treatment. Doxazosin or matched placebo was titrated to 16 mg/day (or maximum tolerable dose). Drinks per week (DPW) and heavy drinking days (HDD) per week were the primary outcomes. Family history density of alcoholism (FHDA), severity of AD and gender were a priori moderators.

Primary Outcome

whether doxazosin, as compared to placebo, decreases the number of drinking days per week (DDW), as measured by the timeline follow-back (TLFB). A drink is defined as a Standard Drinking Unit (SDU).

Interventions

  • DRUG Placebo
  • DRUG Doxazosin

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2011-11-01
Est. Completion 2015-03-01
Phase Early Phase 1
Brown University

231 total trials

What the finished NCT01437046 record still lists

NCT01437046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (23% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01437046 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01437046 about?

NCT01437046 is a clinical study titled "Doxazosin an a1 Antagonist for Alcohol Dependence". Norepinephrine system represents an important treatment target for alcohol dependence (AD) and the α1 -blocker prazosin may reduce alcohol drinking in rodents and alcoholic patients. The α1 -blocker doxazosin demonstrates a more favorable pharmacokinetic profile than prazosin, but has never been stu...

What is the current status of trial NCT01437046?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 41 participants. The study started on 2011-11-01. Estimated completion is 2015-03-01.

What interventions are being tested in trial NCT01437046?

The interventions under investigation include: Placebo (DRUG), Doxazosin (DRUG).

Who is sponsoring clinical trial NCT01437046?

This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01437046's enrollment target sits among peer trials

41 623rd of 2000 higher than 1,373 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 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

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Source: ClinicalTrials.gov NCT01437046, the US trial registry maintained by the National Library of Medicine. NCT01437046 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.