Skip to main content
OpenTrials
Completed

NCT Number: NCT00190957

Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse

Atomoxetine Treatment of Adults with ADHD and Comorbid Alcohol Abuse

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Comorbid Alcohol Abuse Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atomoxetine

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. Total alcohol consumption (mean drinks/day) during the final week of treatment is lower in patients treated with atomoxetine than in patients receiving placebo.

  2. The proportion of drinking days is smaller for atomoxetine-treated patients compared with those in the placebo group.

  3. Time to relapse of alcohol abuse is longer for atomoxetine-treated patients compared with those in the placebo group.

  4. Number of drinks per drinking day is smaller for patients treated with atomoxetine compared with placebo.

  5. The proportion of substance use days, for substances other than alcohol, is smaller among patients treated with atomoxetine as compared with placebo.

  6. 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.

  7. 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.

  8. Improvement in depressive symptoms as assessed by the HAM-D-17.

  9. Improvement in anxiety symptoms as assessed by the HAM-A.

  10. Improvement in self-reported ADHD symptoms as assessed by the ASRS.

  11. Improvement in self-rated symptoms of alcohol cravings as assessed by the OCDS.

  12. Improvement in specific symptoms of ADHD as assessed by the WRAADDS.

  13. Improvement in the self-rated adaptive functioning as assessed by the ASR.

  14. Improvement in the informant-related adaptive functioning as assessed by the ABCL.

  15. Improvement in work, social, and home life functioning as assessed by the Sheehan Disability Scale.

  16. Improvement in general quality of life as assessed by the SF-36 Health Status Survey and the Q-LES-Q-SF.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Nov 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.