Trial intelligence / Profile preview

Pioglitazone in Alcohol Craving

NCT01631630Phase 2

Key facts

Status
Terminated
Start
May 2012
Primary completion
Sep 2015
Countries
1
Sponsor
National Institute on Alcohol Abuse and Alcoholism
Modality
Small Molecules
Conditions
alcohol dependence
01

Overview

Phase 2, randomised, double-blind trial in alcohol dependence comparing Pioglitazone with Placebo (2 arms). Primary endpoints: Alcohol Craving in Response to the Alcohol Cue Script, Alcohol Craving in Response to the Lipopolysaccharide Challenge at 6 hours and 1 more. Started May 2012; status: terminated.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Pioglitazone

    Pioglitazone (titrated to 45mg/day)

  • Placebo

    Placebo matching pioglitazone

03

Who it enrols

Adults aged 21-65 with alcohol dependence, drinking within the past month, without serious medical or psychiatric conditions.

04

Endpoints

Primary

  • Alcohol Craving in Response to the Alcohol Cue Script

  • Alcohol Craving in Response to the Lipopolysaccharide Challenge

  • Alcohol Craving in Response to the Stress Script

Secondary

  • Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period

  • Depression Symptom Ratings Measured Bi-weekly During the Treatment Period

  • Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period

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