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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00147576
• Collaborator: (none)
• Enrollment: 88
• Locations: 11
• Duration (Months): 12
• Patients Per Site: 8
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholism	Drug: CP-866,087	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: Dec 1, 2003
• Actual Study Completion Date: Dec 1, 2004

Outcome Measures

Primary Outcome Measures

1. 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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Cerritos	California	United States	90703
2	Pfizer Investigational Site	New Haven	Connecticut	United States	06504
3	Pfizer Investigational Site	New Haven	Connecticut	United States	06519
4	Pfizer Investigational Site	Washington	District of Columbia	United States	20016
5	Pfizer Investigational Site	Melbourne	Florida	United States	32901
6	Pfizer Investigational Site	Melbourne	Florida	United States	32935
7	Pfizer Investigational Site	Lenexa	Kansas	United States	66219
8	Pfizer Investigational Site	Providence	Rhode Island	United States	02908
9	Pfizer Investigational Site	Charleston	South Carolina	United States	29425
10	Pfizer Investigational Site	San Antonio	Texas	United States	78229-3900
11	Pfizer Investigational Site	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00147576
• Other Study ID Numbers: A5051005
• First Posted: Sep 7, 2005
• Last Update Posted: Oct 2, 2012
• Last Verified: Oct 1, 2012

• Additional relevant MeSH terms: Alcoholism

Study Results

No Results Posted as of Oct 2, 2012