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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00147576
First received: September 2, 2005
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Alcoholism
Drug: CP-866,087
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.

Enrollment: 88
Study Start Date: December 2003
Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147576

Locations
United States, California
Pfizer Investigational Site
Cerritos, California, United States, 90703
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06504
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20016
United States, Florida
Pfizer Investigational Site
Melbourne, Florida, United States, 32901
Pfizer Investigational Site
Melbourne, Florida, United States, 32935
United States, Kansas
Pfizer Investigational Site
Lenexa, Kansas, United States, 66219
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States, 02908
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00147576     History of Changes
Other Study ID Numbers: A5051005
Study First Received: September 2, 2005
Last Updated: October 1, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014