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

Alcoholism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147576
• Other study ID #: A5051005
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2005
• Last updated: October 1, 2012
• Start date: December 2003
• Est. completion date: December 2004

Study information

• Verified date: October 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• CP-866,087

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Cerritos	California
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Lenexa	Kansas
United States	Pfizer Investigational Site	Melbourne	Florida
United States	Pfizer Investigational Site	Melbourne	Florida
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	Providence	Rhode Island
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.