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Trial record 1 of 1 for:    NCT00147576
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Study To Examine Effect Of CP-866,087 On Consumption And Craving Of Alcohol In Alcohol Dependent Subjects.

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ClinicalTrials.gov Identifier: NCT00147576
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 2, 2005
First Posted Date  ICMJE September 7, 2005
Last Update Posted Date October 2, 2012
Study Start Date  ICMJE December 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00147576 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Examine Effect Of CP-866,087 On Consumption And Craving Of Alcohol In Alcohol Dependent Subjects.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Alcoholism
Intervention  ICMJE Drug: CP-866,087
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2005)
88
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00147576
Other Study ID Numbers  ICMJE A5051005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP