Pharmacological Intervention Project (Fluoxetine) (FIDAA)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jack Cornelius, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00027378
First received: December 4, 2001
Last updated: June 17, 2013
Last verified: June 2013
Results First Received: February 8, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Alcoholism
Depression
Interventions: Drug: fluoxetine (Prozac)
Drug: Placebo plus Treatment As Usual

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at the Western Psychiatric Institute and Clinic (WPIC) of the University of Pittsburgh Medical Center (UPMC). Subjects were recruited for participation in the treatment study through referrals from any of the WPIC treatment programs and by responding to newspaper, radio and bus advertisements.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion: bipolar disorder, schizoaffective disorder, schizophrenia, hyper-or hypothyroidism, cardiac, neurological, renal impairment, significant liver disease, received antipsychotic or antidepressant medication, substance abuse or dependence, intravenous drug use, pregnancy, inability or unwillingness to use contraceptive methods, illiteracy.

Reporting Groups
  Description
Fluoxetine Plus Treatment As Usual (TAU) Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
Placebo Plus Treatment as Usual (TAU) Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.

Participant Flow:   Overall Study
    Fluoxetine Plus Treatment As Usual (TAU)     Placebo Plus Treatment as Usual (TAU)  
STARTED     24     26  
COMPLETED     24     23  
NOT COMPLETED     0     3  
Physician Decision                 0                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fluoxetine Plus Treatment As Usual (TAU) Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
Placebo Plus Treatment as Usual (TAU) Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
Total Total of all reporting groups

Baseline Measures
    Fluoxetine Plus Treatment As Usual (TAU)     Placebo Plus Treatment as Usual (TAU)     Total  
Number of Participants  
[units: participants]
  24     26     50  
Age  
[units: participants]
     
<=18 years     2     1     3  
Between 18 and 65 years     22     25     47  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  19.5  ± .94     19.4  ± .91     19.4  ± .92  
Gender  
[units: participants]
     
Female     12     16     28  
Male     12     10     22  
Region of Enrollment  
[units: participants]
     
United States     24     26     50  



  Outcome Measures
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1.  Primary:   Alcohol Use Behaviors   [ Time Frame: Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase. ]

2.  Primary:   Depressive Symptoms   [ Time Frame: Average score as measured by participant's report on the Beck Depression Inventory (BDI). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limited sample size; efficacy of CBT/MET Therapy


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jack R. Cornelius, M.D., M.P.H.
Organization: University of Pittsburgh
phone: 412-246-5149
e-mail: corneliusjr@upmc.edu


Publications of Results:

Responsible Party: Jack Cornelius, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00027378     History of Changes
Other Study ID Numbers: NIAAACOR13370, R01AA015173, R01AA013370, AA-13370
Study First Received: December 4, 2001
Results First Received: February 8, 2012
Last Updated: June 17, 2013
Health Authority: United States: Federal Government