Trial Outcomes & Findings for Pharmacological Intervention Project (Fluoxetine) (NCT NCT00027378)

Results Overview

Alcohol use behaviors measured by drinks per week.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.

Results posted on

2013-07-18

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	24	26
Overall Study COMPLETED	24	23
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Physician Decision	0	3

Baseline Characteristics

Pharmacological Intervention Project (Fluoxetine)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluoxetine Plus Treatment As Usual (TAU) n=24 Participants 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) n=26 Participants Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	19.5 years STANDARD_DEVIATION .94 • n=5 Participants	19.4 years STANDARD_DEVIATION .91 • n=7 Participants	19.4 years STANDARD_DEVIATION .92 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	26 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.

Population: Participants were randomized to either fluoxetine-treated or placebo.

Alcohol use behaviors measured by drinks per week.

Outcome measures

Outcome measures
Measure	Fluoxetine Plus Treatment As Usual (TAU) n=24 Participants 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) n=26 Participants Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
Alcohol Use Behaviors	1.56 standard drink (14 gr. alcohol) Standard Deviation 1.44	1.73 standard drink (14 gr. alcohol) Standard Deviation 1.61

PRIMARY outcome

Timeframe: Average score as measured by participant's report on the Beck Depression Inventory (BDI).

Beck Depression Inventory (BDI) Scores measured at Weeks 1-4, 6, 8, 10, 12. The BDI is a subject reported measure that has a minimum score of 0 and a maximum score of 63. A better outcome would consist of values near the minimum end of the scale (0) and a worse outcome would consist of values near the maximum end of the scale (63).

Outcome measures

Outcome measures
Measure	Fluoxetine Plus Treatment As Usual (TAU) n=24 Participants 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) n=26 Participants Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
Depressive Symptoms	6.79 units on a scale Standard Deviation 7.49	10.46 units on a scale Standard Deviation 10.80

Adverse Events

Fluoxetine Plus Treatment As Usual (TAU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Plus Treatment as Usual (TAU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jack R. Cornelius, M.D., M.P.H.

University of Pittsburgh

Phone: 412-246-5149

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place