Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit/Hyperactivity Disorder; Smoking Cessation
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Varenicline (Chantix)
Intervention description: 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 MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: ADHD; Attention Deficit Hyperactivity Disorder; ADHD medication; Chantix; varenicline; smoking; smoking cessation; quit smoking

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.
    

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.