Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse

Study Overview
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Brief Summary
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Atomoxetine Treatment of Adults with ADHD and Comorbid Alcohol Abuse

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

Conditions
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ADHD, Comorbid Alcohol Abuse

Intervention / Treatment
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* Drug: Atomoxetine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atomoxetine|nan|
|Drug: placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  |