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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Cocaine Abuse