Atomoxetine for Treating Cocaine Abuse in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity; Cocaine-Related Disorders
MeSH terms: Hyperkinesis; Cocaine-Related Disorders; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine
Intervention description: 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 MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ADHD; Cocaine Abuse

Summary:

      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.
    

Eligibility criteria:

        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