Atomoxetine for Treating Cocaine Abuse in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-03-31

Brief Summary

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Studies have shown that individuals with attention deficit hyperactivity disorder (ADHD) are at greater risk for having a substance use disorder compared to people who do not have ADHD. Rates of cocaine abuse in adults with ADHD are significantly higher than they are in adults who do not have ADHD. Some clinicians suggest that adults with ADHD may abuse cocaine in order to self-medicate their ADHD symptoms. Atomoxetine is a drug that has been effective in treating ADHD. This study will evaluate the effectiveness of atomoxetine in reducing cocaine use in people with ADHD who abuse cocaine.

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Detailed Description

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ADHD is a neurologic disorder that is thought to be caused by chemical imbalances of certain neurotransmitters in the brain. The disorder can cause inattention, hyperactivity, and impulsivity. Cocaine abuse rates in adults with ADHD are significantly higher than they are in adults who do not have the disorder. This may be reflective of an attempt by individuals with ADHD to self-treat symptoms. Atomoxetine is an FDA-approved drug that is used to increase the ability to pay attention and decrease impulsiveness and hyperactivity in children and adults with ADHD. The drug is in a class of medications called selective norepinephrine reuptake inhibitors and works by increasing the levels of norepinephrine, a natural substance in the brain that affects a person's attention and impulsivity. It is possible that reducing ADHD symptoms in cocaine abusers with ADHD will help decrease their need for cocaine. This study will evaluate the effectiveness of atomoxetine in reducing cocaine use in people with ADHD who abuse cocaine.

Participants in this open label study will receive atomoxetine for 12 weeks, and will take one dose each morning for the duration of the study. Doses will be increased gradually to minimize side effects and enhance treatment compliance. In addition, all participants will receive individualized relapse prevention therapy once weekly. Participants will be required to report to the study site three times a week to receive medication, complete questionnaires regarding ADHD symptoms and substance use behavior, and provide a urine sample while being supervised by study staff. Also, vital signs will be monitored and medication side effects will be assessed at each visit. Participants will report to the study site 6 months after starting in the study for a follow-up visit, at which time ADHD symptoms, substance use behavior, and social functioning will be assessed.

Conditions

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Attention Deficit Disorder With Hyperactivity Cocaine-Related Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atomoxetine

Group Type EXPERIMENTAL

Atomoxetine

Intervention Type DRUG

At the start of week 7, patients will be maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if less than a 50% reduction of symptoms on the ADHD Rating Scale occurs, and if the patient is tolerating the medication well.

Interventions

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Atomoxetine

At the start of week 7, patients will be maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if less than a 50% reduction of symptoms on the ADHD Rating Scale occurs, and if the patient is tolerating the medication well.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meets DSM-IV criteria for cocaine dependence and adult ADHD
* Describes cocaine as the primary drug of abuse
* Meets DSM-IV criteria for cocaine dependence

Exclusion Criteria

* Meets DSM-IV criteria for current Axis I psychiatric disorders that require a psychiatric intervention (except ADHD or substance abuse)
* Current major depression
* Unstable physical disorders that might make participation unsafe (e.g., uncontrolled high blood pressure and tachycardia \[systolic blood pressure greater than 150 mm Hg, diastolic blood pressure greater than 90 mm Hg, or a sitting heart rate greater than 100\])
* Acute hepatitis (individuals with chronic mildly elevated transaminase levels of less than 2 or 3 times the normal limit are not excluded)
* Diabetes
* Coronary vascular disease, as indicated by a history or suspected by an abnormal electrocardiogram
* History of cardiac symptoms
* History of seizures
* Narrow angle glaucoma
* Use of monoamine oxidase inhibitors (MAOIs) within 2 weeks of starting treatment with atomoxetine
* Currently taking prescribed psychotropic medications
* Currently taking medications for the treatment of ADHD
* Known sensitivity to atomoxetine
* Current suicidal ideation or history of suicidal or homicidal behavior within 2 years prior to study entry
* Pregnant or breastfeeding
* Physiologically dependent on any drugs other than nicotine or marijuana
* History of schizophrenia, bipolar disorder, or other psychotic disorders
* Currently taking cough medicine (e.g., dextromethorphan) and/or albuterol

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes