Attention Deficit Disorder With HyperactivityPhase 2NCT00664703
Effectiveness of Lobeline in Treating Symptoms of ADHD in Adult Patients
A Phase 2 study testing Lobeline sulfate and Methylphenidate HCl in people with Attention Deficit Disorder With Hyperactivity, run by Yaupon Therapeutics at 1 site in United States.
Trial summary
The study will evaluate the effectiveness of the nonstimulant medication lobeline in improving symptoms of attention deficit hyperactivity disorder in adults. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Lobeline sulfate and Methylphenidate HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center, University of Kentucky
Lexington, Kentucky, 40506
About this study
Official title: A Double-Blind, Double-Dummy, Placebo-Controlled, Dose Ranging Study of 7.5, 15, and 30 mg of Sublingual Lobeline in Adult ADHD Patients
The study will evaluate the effectiveness of the nonstimulant medication lobeline in improving symptoms of attention deficit hyperactivity disorder in adults.
Read the 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.
- Being tested
- Lobeline sulfate, Methylphenidate HCl, Placebo
- Keywords
- Dopamine Uptake Inhibitors, Dopamine, Methylphenidate, Mental Disorders Diagnosed in Childhood, Neurologic Manifestations, Attention Deficit and Disruptive Behavior Disorders, Hyperkinesis, Dyskinesias
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders, Neurologic Manifestations, Attention Deficit and Disruptive Behavior Disorders, Hyperkinesis, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lobeline sulfateDrug
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.
Methylphenidate HClDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Lobeline 7.5 mg | Experimental | Sublingual tablet Receives: Drug: Lobeline sulfate |
| Lobeline 15 mg | Experimental | Sublingual tablet Receives: Drug: Lobeline sulfate |
| Lobeline 30 mg | Experimental | Sublingual tablet Receives: Drug: Lobeline sulfate |
| Methylphenidate HCl 15 mg | Active comparator | Capsule Receives: Drug: Methylphenidate HCl |
| Methylphenidate HCl 30 mg | Active comparator | Capsule Receives: Drug: Methylphenidate HCl |
| Lobeline 0 mg (placebo) | Placebo comparator | Sublingual tablet Receives: Drug: Placebo |
| Methylphenidate HCl 0 mg (placebo) | Placebo comparator | Capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention as measured by Conners' Continuous Performance Task(CPT)
Measured: Measured at Lab Visits 1 through 7
Impulsivity as measured by the CPT and Stop Signal Reaction Test
Measured: Measured at Lab Visits 1 through 7
Working memory as measured by Digit Span Backwards and Two-Back Test
Measured: Measured at Lab Visits 1 through 7
Secondary outcomes (3)
Subjective effects
Measured: Measured at Lab Visits 1 through 7
Cardiovascular effects
Measured: Measured at Lab Visits 1 through 7
Drug effects
Measured: Measured at Lab Visits 1 through 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaupon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Catherine A. Martin, MD, Principal investigator, University of Kentucky Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664703
- Sponsor's protocol ID
- R43MH081553
- Other IDs
- R43MH081553, DATR BT-BU, 2007LOBADHD-201-US, 7-0432-F2L
- Status last verified
- Jun 2013
- First submitted
- 21 Apr 2008
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Double-Dummy, Placebo-Controlled, Dose Ranging Study of 7.5, 15, and 30 mg of Sublingual Lobeline in Adult ADHD Patients
- ClinicalTrials.gov ID
- NCT00664703
- Acronym / sponsor ID
- R43MH081553
- Keywords
- Dopamine Uptake Inhibitors, Dopamine, Methylphenidate, Mental Disorders Diagnosed in Childhood, Neurologic Manifestations, Attention Deficit and Disruptive Behavior Disorders, Hyperkinesis, Dyskinesias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Yaupon TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Lobeline 7.5 mg | Experimental | Drug: Lobeline sulfateSublingual tablet |
| Lobeline 15 mg | Experimental | Drug: Lobeline sulfateSublingual tablet |
| Lobeline 30 mg | Experimental | Drug: Lobeline sulfateSublingual tablet |
| Methylphenidate HCl 15 mg | Active comparator | Drug: Methylphenidate HClCapsule |
| Methylphenidate HCl 30 mg | Active comparator | Drug: Methylphenidate HClCapsule |
| Lobeline 0 mg (placebo) | Placebo comparator | Drug: PlaceboSublingual tablet |
| Methylphenidate HCl 0 mg (placebo) | Placebo comparator | Drug: PlaceboCapsule |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lobeline sulfateEach 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. | Drug | Lobeline 15 mg, Lobeline 30 mg, Lobeline 7.5 mg |
| Methylphenidate HClEach 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. | Drug | Methylphenidate HCl 15 mg, Methylphenidate HCl 30 mg |
| PlaceboEach 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. | Drug | Lobeline 0 mg (placebo), Methylphenidate HCl 0 mg (placebo) |
Primary outcome
Attention as measured by Conners' Continuous Performance Task(CPT)
Time frame: Measured at Lab Visits 1 through 7
Impulsivity as measured by the CPT and Stop Signal Reaction Test
Time frame: Measured at Lab Visits 1 through 7
Working memory as measured by Digit Span Backwards and Two-Back Test
Time frame: Measured at Lab Visits 1 through 7
3 secondary outcomes
Subjective effects
Time frame: Measured at Lab Visits 1 through 7
Cardiovascular effects
Time frame: Measured at Lab Visits 1 through 7
Drug effects
Time frame: Measured at Lab Visits 1 through 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine A. Martin, MD principal investigator
University of Kentucky Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lobeline sulfate and Methylphenidate HCl in people with Attention Deficit Disorder With Hyperactivity, run by Yaupon Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention as measured by Conners' Continuous Performance Task(CPT) (time frame: Measured at Lab Visits 1 through 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.