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Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse
This study has been completed.
First Received: September 12, 2005   Last Updated: November 5, 2007   History of Changes
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00190957
  Purpose

Atomoxetine Treatment of Adults with ADHD and Comorbid Alcohol Abuse


Condition Intervention Phase
ADHD
Comorbid Alcohol Abuse
 Drug: Atomoxetine
Drug: placebo
 Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse: A Randomized, Placebo-Controlled Trial

Resource links provided by NLM:

Drug Information available for: Atomoxetine hydrochloride Atomoxetine
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To test that atomoxetine is superior to placebo in reducing ADHD severity as measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total score and is superior to placebo in time to relapse of alcohol abuse at 12 weeks.

Secondary Outcome Measures:
  • Total alcohol consumption (mean drinks/day) during the final week of treatment is lower in patients treated with atomoxetine than in patients receiving placebo.
  • The proportion of drinking days is smaller for atomoxetine-treated patients compared with those in the placebo group.
  • Time to relapse of alcohol abuse is longer for atomoxetine-treated patients compared with those in the placebo group.
  • Number of drinks per drinking day is smaller for patients treated with atomoxetine compared with placebo.
  • The proportion of substance use days, for substances other than alcohol, is smaller among patients treated with atomoxetine as compared with placebo.
  • After approximately 12 weeks of treatment, patients who receive atomoxetine will have superior social and occupational functioning compared with those who receive placebo as assessed by changes in the EWPS.
  • Global functioning as assessed by the CGI-Overall-S and the CGI-I are superior in patients treated with atomoxetine as compared with those treated with placebo.
  • Improvement in depressive symptoms as assessed by the HAM-D-17.
  • Improvement in anxiety symptoms as assessed by the HAM-A.
  • Improvement in self-reported ADHD symptoms as assessed by the ASRS.
  • Improvement in self-rated symptoms of alcohol cravings as assessed by the OCDS.
  • Improvement in specific symptoms of ADHD as assessed by the WRAADDS.
  • Improvement in the self-rated adaptive functioning as assessed by the ASR.
  • Improvement in the informant-related adaptive functioning as assessed by the ABCL.
  • Improvement in work, social, and home life functioning as assessed by the Sheehan Disability Scale.
  • Improvement in general quality of life as assessed by the SF-36 Health Status Survey and the Q-LES-Q-SF.

Estimated Enrollment: 140
Study Start Date: August 2004
Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

You must be at least 18 years old.

You must have a diagnosis of ADHD and a diagnosis of alcohol abuse or dependence.

You must have acceptable results on blood and urine tests and an electrocardiogram (ECG).

Your recent drinking history must meet specific requirements.

Exclusion Criteria:

You have taken atomoxetine in the past.

You have a psychiatric disorder, other than ADHD and alcohol abuse or dependence, for which you will need psychiatric medication.

You have cognitive impairment (such as memory loss), a brain injury, or a seizure disorder.

You have a history of severe allergies to more than 1 class of medication or multiple bad reaction to drugs.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190957

Locations
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
El Centro, California, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Poway, California, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
San Diego, California, United States
United States, Connecticut
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
New London, Connecticut, United States
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Orlando, Florida, United States
United States, Massachusetts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Cambridge, Massachusetts, United States
United States, Michigan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Okemos, Michigan, United States
United States, Missouri
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Columbia, Missouri, United States
United States, New Jersey
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Moorestown, New Jersey, United States
United States, New York
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
New York, New York, United States
United States, South Carolina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Charleston, South Carolina, United States
United States, Virginia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Herndon, Virginia, United States
United States, Washington
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Seattle, Washington, United States
United States, Wisconsin
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Middleton, Wisconsin, United States
Canada
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Vancouver, Canada
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: 7069, B4Z-MC-LYBY
Study First Received: September 12, 2005
Last Updated: November 5, 2007
ClinicalTrials.gov Identifier: NCT00190957     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neurotransmitter Agents
Adrenergic Agents
Mental Disorders
Alcoholism
Substance-Related Disorders
 Atomoxetine
Disorders of Environmental Origin
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Disorders of Environmental Origin
 Atomoxetine
Pharmacologic Actions
Mental Disorders
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on September 02, 2009



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