Effectiveness of Lobeline in Treating Symptoms of ADHD in Adult Patients

NCT00664703 | Completed Phase 2 DMC

• 4 other identifiers: R43MH081553DATR BT-BU2007LOBADHD-201-US7-0432-F2L
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate the effectiveness of the nonstimulant medication lobeline in improving symptoms of attention deficit hyperactivity disorder in adults.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Dopamine Uptake Inhibitors; Dopamine; Methylphenidate; Mental Disorders Diagnosed in Childhood; Neurologic Manifestations; Attention Deficit and Disruptive Behavior Disorders; Hyperkinesis; Dyskinesias

Outcome Measures

Primary Outcomes (3)

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

  Measured at Lab Visits 1 through 7

• Impulsivity as measured by the CPT and Stop Signal Reaction Test

  Measured at Lab Visits 1 through 7

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

  Measured at Lab Visits 1 through 7

Secondary Outcomes (3)

• Subjective effects

  Measured at Lab Visits 1 through 7

• Cardiovascular effects

  Measured at Lab Visits 1 through 7

• Drug effects

  Measured at Lab Visits 1 through 7

Study Arms (7)

Lobeline 7.5 mg

EXPERIMENTAL

Sublingual tablet

Drug: Lobeline sulfate

Lobeline 15 mg

EXPERIMENTAL

Sublingual tablet

Drug: Lobeline sulfate

Lobeline 30 mg

EXPERIMENTAL

Sublingual tablet

Drug: Lobeline sulfate

Methylphenidate HCl 15 mg

ACTIVE COMPARATOR

Capsule

Drug: Methylphenidate HCl

Methylphenidate HCl 30 mg

ACTIVE COMPARATOR

Capsule

Drug: Methylphenidate HCl

Lobeline 0 mg (placebo)

PLACEBO COMPARATOR

Sublingual tablet

Drug: Placebo

Methylphenidate HCl 0 mg (placebo)

PLACEBO COMPARATOR

Capsule

Drug: Placebo

Interventions

Lobeline sulfate DRUG

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.

Lobeline 15 mg; Lobeline 30 mg; Lobeline 7.5 mg

Methylphenidate HCl DRUG

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 HCl 15 mg; Methylphenidate HCl 30 mg

Placebo DRUG

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.

Lobeline 0 mg (placebo); Methylphenidate HCl 0 mg (placebo)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yaupon Therapeutics: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

General Clinical Research Center, University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders; Neurologic Manifestations; Attention Deficit and Disruptive Behavior Disorders; Hyperkinesis; Dyskinesias

Interventions

Lobeline; Methylphenidate

Condition Hierarchy (Ancestors)

Mental Disorders; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Catherine A. Martin, MD

  University of Kentucky Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 23, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 20, 2013

Record last verified: 2013-06

Locations

US (1)