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NCT01169610 · ClinicalTrials.gov registry record · Phase 3

Varenicline and Alcohol in Inpatient Addictions Program (IAP)

A Phase 3 study, sponsored by Mayo Clinic.

Terminated
Registry status
Phase 3
Development phase
1
Enrollment target

NCT01169610: Clinical Trial Phase 3 study, sponsored by Mayo Clinic.

NCT01169610 is a Phase 3 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01169610, a Phase 3 study, was terminated before completion, sponsored by Mayo Clinic.

TERMINATED
Registry status
Phase 3
Development phase
1 participants
Enrollment target

Study Summary

The overall hypothesis of this line of research is that varenicline will decrease alcohol consumption and tobacco use and will increase alcohol and tobacco abstinence rates. In order to explore this hypothesis, the investigators will conduct a two-phase study: 1) an open label pilot study investigating the effect of varenicline on reduction of and abstinence from alcohol and tobacco; and 2) an optional MR spectroscopy to investigate whether glutamate and other brain metabolites correlate to measures of alcohol craving severity and/or subsequent varenicline treatment response.

Primary Outcome

No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.

Interventions

  • DRUG Varenicline

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2011-01
Est. Completion 2013-06
Phase Phase 3
Mayo Clinic

2,844 total trials

Why NCT01169610 stopped before completion

NCT01169610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Varenicline is the first listed.

NCT01169610 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01169610 about?

NCT01169610 is a clinical study titled "Varenicline and Alcohol in Inpatient Addictions Program (IAP)". The overall hypothesis of this line of research is that varenicline will decrease alcohol consumption and tobacco use and will increase alcohol and tobacco abstinence rates. In order to explore this hypothesis, the investigators will conduct a two-phase study: 1) an open label pilot study investigat...

What is the current status of trial NCT01169610?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2011-01. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01169610?

The interventions under investigation include: Varenicline (DRUG).

Who is sponsoring clinical trial NCT01169610?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01169610's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01169610, the US trial registry maintained by the National Library of Medicine. NCT01169610 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.