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| Descriptive Information Fields | |||||||||
| Brief Title † | Effectiveness of the Non-Stimulant Medication Lobeline in Improving Symptoms of Attention Deficit Hyperactivity Disorder in Adults | ||||||||
| Official Title † | A Double-Blind, Placebo-Controlled, Dose Ranging Study of 7.5, 15, and 30 mg of Sublingual Lobeline in Adult ADHD Patients | ||||||||
| Brief Summary | The study will evaluate the effectiveness of the nonstimulant medication lobeline in improving symptoms of attention deficit hyperactivity disorder in adults. |
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| 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. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Factorial Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Attention as measured by Conners' Continuous Performance Tests (CPT) [ Time Frame: Measured at Lab Visits 1 through 7 ] [ Designated as safety issue: No ] Impulsivity as measured by Conners' CPT [ Time Frame: Measured at Lab Visits 1 through 7 ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Working memory [ Time Frame: Measured at Lab Visits 1 through 7 ] [ Designated as safety issue: No ] Subjective effects [ Time Frame: Measured at Lab Visits 1 through 7 ] [ Designated as safety issue: No ] Cardiovascular effects [ Time Frame: Measured at Lab Visits 1 through 7 ] [ Designated as safety issue: Yes ] |
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| Condition † | Attention Deficit Disorder With Hyperactivity | ||||||||
| Intervention † | Drug: Lobeline Placebo Drug: Lobeline Mid Dose Drug: Lobeline Low Dose Drug: Lobeline High Dose Drug: Methylphenidate Low Dose Drug: Methylphenidate High Dose Drug: Methylphenidate Placebo |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 15 | ||||||||
| Start Date † | July 2008 | ||||||||
| Completion Date | September 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00664703 | ||||||||
| Organization ID | R43 MH081553 | ||||||||
| Secondary IDs †† | DATR BT-BU, 2007LOBADHD-201-US, 7-0432-F2L | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | July 2008 | ||||||||
| First Received Date † | April 21, 2008 | ||||||||
| Last Updated Date | July 1, 2008 | ||||||||
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