Study To Examine Effect Of CP-866,087 On Consumption And Craving Of Alcohol In Alcohol Dependent Subjects.
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
1 other identifier
interventional
88
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2003
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedOctober 2, 2012
October 1, 2012
September 2, 2005
October 1, 2012
Conditions
Outcome Measures
Primary Outcomes (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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (11)
Pfizer Investigational Site
Cerritos, California, 90703, United States
Pfizer Investigational Site
New Haven, Connecticut, 06504, United States
Pfizer Investigational Site
New Haven, Connecticut, 06519, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, 20016, United States
Pfizer Investigational Site
Melbourne, Florida, 32901, United States
Pfizer Investigational Site
Melbourne, Florida, 32935, United States
Pfizer Investigational Site
Lenexa, Kansas, 66219, United States
Pfizer Investigational Site
Providence, Rhode Island, 02908, United States
Pfizer Investigational Site
Charleston, South Carolina, 29425, United States
Pfizer Investigational Site
San Antonio, Texas, 78229-3900, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
December 1, 2003
Study Completion
December 1, 2004
Last Updated
October 2, 2012
Record last verified: 2012-10