Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00190957

First received: September 12, 2005

Last updated: November 5, 2007

Last verified: November 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

November 5, 2007

Start Date ^ICMJE

August 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00190957 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse

Official Title ^ICMJE

Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse: A Randomized, Placebo-Controlled Trial

Brief Summary

Atomoxetine Treatment of Adults with ADHD and Comorbid Alcohol Abuse

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

ADHD
Comorbid Alcohol Abuse

Intervention ^ICMJE

Drug: Atomoxetine
Drug: placebo

Study Arm (s)

Not Provided

Publications *

Wilens TE, Adler LA, Tanaka Y, Xiao F, D'Souza DN, Gutkin SW, Upadhyaya HP. Correlates of alcohol use in adults with ADHD and comorbid alcohol use disorders: exploratory analysis of a placebo-controlled trial of atomoxetine. Curr Med Res Opin. 2011 Dec;27(12):2309-20. Epub 2011 Oct 27.

* 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

Enrollment ^ICMJE

140

Completion Date

January 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00190957

Other Study ID Numbers ^ICMJE

7069, B4Z-MC-LYBY

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

November 2007

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

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