Effectiveness of Lobeline in Treating Symptoms of ADHD in Adult Patients
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the effectiveness of the nonstimulant medication lobeline in
      improving symptoms of attention deficit hyperactivity disorder in adults.
    

Detailed description: 
      Attention deficit hyperactivity disorder (ADHD) affects approximately 8 million adults in the
      United States. Adults with ADHD may experience difficulty concentrating, poor organization
      ability, mood swings, and trouble completing work. If not managed properly, ADHD can lead to
      behavioral, emotional, academic, social, and work-related problems. Neurobiological research
      has shown that people with ADHD exhibit low levels of dopamine, a neurotransmitter of the
      brain that controls a person's ability to concentrate and focus on surroundings. Lobeline, a
      nonstimulant medication that acts to alter dopamine uptake, may be effective in improving
      abnormalities in brain dopamine levels. Although lobeline has been successfully used as a
      smoking cessation aid because of its ability to inhibit nicotine-induced hyperactivity, the
      effectiveness of lobeline as a treatment for ADHD has not been explored. This study will
      evaluate the effectiveness of lobeline in improving adult ADHD symptoms, specifically
      inattention, impulsivity, and memory problems. This study will also evaluate any side effects
      of lobeline treatment.

      Participation in this study will last between 4 and 5 weeks, during which participants will
      attend 10 study visits at the General Clinical Research Center (GCRC). Participants will
      first undergo a medical evaluation visit that will include a physical exam, electrocardiogram
      (EKG), blood draw, urine testing, and breath sampling. Participants will then return for an
      orientation visit to complete questionnaires and to receive training on the computer and on
      memory tasks to be performed during later visits.

      The next 7 visits will comprise the laboratory testing and medication treatment portion of
      the study. Each visit will last 4.5 hours and will include urine and breath sampling,
      computer and memory tasks, questionnaires, vital sign measurements, and medication
      distribution. Participants will be randomly assigned to take two different pills at each lab
      visit. One pill will be a placebo of lobeline or methylphenidate, a medication stimulant used
      in treating ADHD, and the other pill will be active lobeline or methylphenidate. Drug
      combinations and doses will vary each day, but participants will never receive two active
      pills on the same day. All participants will undergo a follow-up evaluation between 7 and 14
      days after the final lab visit. The evaluation will include questions about side effects from
      study medication, breath and urine sampling, a blood draw, and a physical exam.
    

Intervention name(s): Lobeline sulfate; Methylphenidate HCl; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each laboratory day, participants will receive one capsule containing either methylphenidate HCl (15 or 30 mg) or placebo, and one sublingual tablet containing either lobeline (7.5, 15, or 30 mg) or placebo.; Each laboratory day, participants will receive one capsule containing either methylphenidate HCl (15 or 30 mg) or placebo, and one sublingual tablet containing either lobeline (7.5, 15, or 30 mg) or placebo.; Each laboratory day, participants will receive one capsule containing either methylphenidate HCl (15 or 30 mg) or placebo, and one sublingual tablet containing either lobeline (7.5, 15, or 30 mg) or placebo.
Intervention MeSH terms: Methylphenidate; Lobeline
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dopamine Uptake Inhibitors; Dopamine; Methylphenidate; Mental Disorders Diagnosed in Childhood; Neurologic Manifestations; Attention Deficit and Disruptive Behavior Disorders; Hyperkinesis; Dyskinesias