Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)

NCT ID: NCT00907218

Last Updated: 2017-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-05-31

Brief Summary

The purpose of this research study is to learn about the efficacy of a medication called varenicline (Chantix) in treating ADHD in adults and in reducing cigarette smoking in adults with ADHD. The investigators hypothesize that ADHD symptomatology in adults with ADHD will be improved with varenicline treatment. The investigators also hypothesize that varenicline treatment will result in significant reductions in cigarette smoking. Another objective of this study is to more fully evaluate the response and tolerability to varenicline in this group of cigarette smoking adults with ADHD.

Conditions

Attention Deficit/Hyperactivity Disorder; Smoking Cessation

Keywords

ADHD; Attention Deficit Hyperactivity Disorder; ADHD medication; Chantix; varenicline; smoking; smoking cessation; quit smoking

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Adults who meet DSM-IV-TR criteria for ADHD and smoke cigarettes.

Group Type: EXPERIMENTAL

Varenicline (Chantix)

Intervention Type: DRUG

Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if tolerated. Maximum dose will be 2 mg daily.

Interventions

Varenicline (Chantix)

Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if tolerated. Maximum dose will be 2 mg daily.

Intervention Type: DRUG

Other Intervention Names

Chantix(varenicline) is a smoking cessation medicine.

Eligibility Criteria

Inclusion Criteria

• Male and female outpatients from 18-60 years of age;
• A cigarette smoking history of at least 3 months, and currently smoking;
• An interest in quitting smoking and a willingness to comply with all study procedures and medication instructions;
• A current DSM-IV-TR diagnosis of ADHD confirmed by clinical psychiatric evaluation and/or ADHD module of structured diagnostic interview, completed by study clinician.
• For females of child-bearing potential: pregnancy test at screening visit is negative and the subject does not plan to become pregnant during the study.

Exclusion Criteria

• Pregnancy or breast-feeding;
• Clinically significant and/or unstable medical condition including renal, hepatic, or neurological, based upon a medical history and vital signs;
• Ongoing treatment with medications which may be affected (altered blood levels) if subjects stop smoking in the study, including insulin, theophylline, and blood thinners, as determined by clinician;
• Clinically significant cardiovascular history, including myocardial infarction, untreated hypertension, atrial fibrillation, or arrhythmia;
• Current untreated psychiatric comorbidity which the investigator judges to be of greater than mild severity, including Major Depressive Disorder;
• Current psychiatric comorbidity, including suicidality, homicidality, psychosis, determined by the clinician to be clinically significant and/or unstable
• Lifetime history of DSM-IV Bipolar I disorder, Schizophrenia, or suicide attempt as determined through clinical evaluation or diagnostic interview;
• Currently (within 3 months) meets DSM-IV criteria for abuse or dependence for any psychoactive substance other than nicotine;
• Current treatment with mood stabilizers, anti-psychotics, nicotine replacement therapies, or varenicline;
• Mental retardation (IQ < 75);
• History of intolerance or allergy to varenicline.
• Clinically significant abnormal screening values including:

• Consistent readings of hypertension (>140/90) during screening period (including screening and baseline visits), defined as two or more readings (each being the average of three measurements) at a single visit with systolic blood pressure, SBP > 140 and/or diastolic blood pressure, DBP, > 90, and confirmed by manual reading.

Subjects with isolated incidences (of triplicate average BP) of SBP > 140 and/or DBP > 90 at baseline/week 0 visit, confirmed by manual reading, which are determined to be clinically significant.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Timothy Wilens, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy Wilens, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Countries

United States

Other Identifiers

2009-P-000444

Identifier Type: -

Identifier Source: org_study_id