| City: |
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Lexington |
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State:
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KY |
| Zip Code: |
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40506 |
| Conditions: |
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Attention Deficit Disorder With Hyperactivity |
| Purpose: |
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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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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- Diagnosis of ADHD, including degree of symptomatology, as determined by a structured
clinical assessment based on the DSM-IV (SCID-1); supplemented by administration of
the Schedule for Affective Disorders and Schizophrenia for School-Age Children,
Epidemiologic version (KSADS-E) and administration of the Conners' Adult ADHD Rating
Scale (CAARS);
- Healthy males or females aged 21 to 45 years;
- A body mass index (BMI) between 18 and 30;
- Ability and willingness to provide written consent, comply with study instructions,
and commit to all study visits and procedures;
- Adequate means of contacting the investigator in case of emergency or have means to
be contacted readily by the investigator;
- No medical contraindications determined by the following: an adequate medical
history, a physical examination including vital signs, 12-lead electrocardiogram
(ECG); complete blood count with differential liver function and blood chemistry
tests and urinalysis, including urine sample for drug screening;
- A negative urine drug test (barbiturates, benzodiazepines, amphetamines, opiates,
cocaine, cannabinoids, ethanol) at screening, and at each laboratory day;
- Subjects must be non-smokers. A breath sample analysis will be conducted on-site with
an Alco-Sensor Intoximeter, and an Innovative Medical Monitoring carbon monoxide (CO)
Monitor, and must reveal a CO value of less than or equal to 8 ppm and a negative
cotinine urine or saliva test (>100 ng/mL);
- Females must have a negative pregnancy test (beta human chorionic gonadotrophin) at
screening, and prior to each study drug administration. Females capable of
childbearing are required to use a medically accepted form of contraception for at
least 1 month prior to study start, throughout the study duration, and for at least 1
month after study medication is discontinued.
Exclusion Criteria:
- Current participation in the follow-up period of a preceding drug research study;
- Presence of unresolved/unstable psychiatric comorbidities as determined by clinical
assessment and structured clinical interview using the SCID-1, that could interfere
with study evaluations or affect a subject's safety;
- Recent history of drug addiction and/or alcoholism; and nicotine dependence within
the past 6 months, as determined by psychiatric clinical assessment;
- Current significant acute or chronic medical disease, or any historical medical
condition that could relapse during or immediately after the study and, in the
investigator's opinion, may interfere with study evaluations or affect a subject's
safety;
- Presence of potential organic etiology (e.g., a serious head injury or injury
resulting in loss of consciousness, seizure disorder, thyroid problems, etc.) for
ADHD symptomatology, as determined by clinical assessment;
- Blood pressure over 160/100 mmHg or under 90/40 mmHg, or heart rate over 120 beats
per minute or below 40 beats per minute, obtained on two consecutive measures over 15
minutes when the subject is at rest;
- Exposure to any investigational new drug within 30 days of screening;
- Regular use of any prescription, over-the-counter drugs or likely need for
concomitant treatment medication during the study period;
- Use of herbal products, including St. John's Wort, for 2 weeks prior to study
initiation and throughout the study duration. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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