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 range

21 Years – 45 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Attention as measured by Conners' Continuous Performance Task(CPT)

Timeframe: Measured at Lab Visits 1 through 7

Impulsivity as measured by the CPT and Stop Signal Reaction Test

Timeframe: Measured at Lab Visits 1 through 7

Working memory as measured by Digit Span Backwards and Two-Back Test

Timeframe: Measured at Lab Visits 1 through 7

Trial details

NCT IDNCT00664703

SponsorYaupon Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-01

View on ClinicalTrials.gov More Attention Deficit Disorder With Hyperactivity trials

Who can participate

Age range

21 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Attention as measured by Conners' Continuous Performance Task(CPT)

Timeframe: Measured at Lab Visits 1 through 7

Impulsivity as measured by the CPT and Stop Signal Reaction Test

Timeframe: Measured at Lab Visits 1 through 7

Working memory as measured by Digit Span Backwards and Two-Back Test

Timeframe: Measured at Lab Visits 1 through 7