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

September 12, 2005
November 5, 2007
August 2004
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00190957 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse
Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse: A Randomized, Placebo-Controlled Trial

Atomoxetine Treatment of Adults with ADHD and Comorbid Alcohol Abuse

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • ADHD
  • Comorbid Alcohol Abuse
  • Drug: Atomoxetine
  • Drug: placebo
Not Provided
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. doi: 10.1185/03007995.2011.628648. Epub 2011 Oct 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
January 2006
Not Provided

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00190957
7069, B4Z-MC-LYBY
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
November 2007

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