Study To Examine Effect Of CP-866,087 On Consumption And Craving Of Alcohol In Alcohol Dependent Subjects.

October 1, 2012 updated by: Pfizer

Randomized, Placebo-Controlled Parallel Group Study Comparing Effect Of Three Doses Of CP-866,087 And Naltrexone On Acute Alcohol Consumption And Craving After Seven Days Of Treatment In Alcohol Dependent (DSM IV) Subjects Who Are Not Currently Seeking Treatment

Test the hypothesis that increasing doses of CP-866,087 will decrease the total number of drinks consumed during a 2 hour acute alcohol consumption assessment and to determine the safety and tolerability of multiple doses of CP-866,087 in alcohol dependent subjects compared to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cerritos, California, United States, 90703
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Pfizer Investigational Site
      • New Haven, Connecticut, United States, 06504
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Pfizer Investigational Site
    • Florida
      • Melbourne, Florida, United States, 32901
        • Pfizer Investigational Site
      • Melbourne, Florida, United States, 32935
        • Pfizer Investigational Site
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Pfizer Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229-3900
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject meets the DSM-IV criterion for current alcohol dependence.
  • Subject is currently not engaged in, and does not want, treatment for alcohol related problems.

Exclusion Criteria:

  • Subject meets criteria for current DSM-IV diagnosis for any other psychoactive substance abuse or dependence disorder, excluding nicotine and caffeine.
  • Specialized inpatient or outpatient alcoholism or other addiction treatment (except nicotine) within the past 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The amount of alcohol consumed will be based on the total number of standardized drinks consumed during a two-hour laboratory-based self-administration procedure following 7 days of treatment with study medication.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

October 2, 2012

Last Update Submitted That Met QC Criteria

October 1, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5051005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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