Effectiveness of Lobeline in Treating Symptoms of ADHD in Adult Patients (NCT00664703) | Clinical Trial Compass
CompletedPhase 2
Effectiveness of Lobeline in Treating Symptoms of ADHD in Adult Patients
United States13 participantsStarted 2008-07
Plain-language summary
The study will evaluate the effectiveness of the nonstimulant medication lobeline in improving symptoms of attention deficit hyperactivity disorder in adults.
Who can participate
Age range21 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
* Female…
What they're measuring
1
Attention as measured by Conners' Continuous Performance Task(CPT)
Timeframe: Measured at Lab Visits 1 through 7
2
Impulsivity as measured by the CPT and Stop Signal Reaction Test
Timeframe: Measured at Lab Visits 1 through 7
3
Working memory as measured by Digit Span Backwards and Two-Back Test