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

Phase 4

Terminated

• Conditions: Smoking Cessation; Attention Deficit/Hyperactivity Disorder
• Interventions: Drug: Varenicline (Chantix)

• Registration Number: NCT00907218
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-21
• Study First Posted: 2009-05-22
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2013-05-09
• Results First Submitted QC: 2013-07-31
• Results First Posted: 2013-09-23
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Varenicline (Chantix)	Adults who meet DSM-IV-TR criteria for ADHD and smoke cigarettes.

Primary Outcome Measures

Name	Time	Method
The DSM-IV Based Adult ADHD Investigator Symptom Rating Scale (AISRS)	Weekly for 7 weeks	The AISRS is an 18-item questionnaire administered by the clinician assessing each of the individual DSM-IV symptoms of ADHD. Each symptom is rated on a scale of severity from 0 (none) to 3 (severe), and the 18 symptom questions are summed to calculate a total score. The minimum total score is a 0, while the maximum total score is a 54.
Time Line Follow Back of Cigarette Smoking	Weekly for 7 weeks	The reduction in cigarette smoking, defined as the change from baseline on the amount of cigarettes per day smoked (cpd), using the time-line follow back method. This method involves asking subjects to retrospectively estimate their cigarette use 7 days to 2 years prior to the interview date.

Secondary Outcome Measures

Name	Time	Method
Spontaneous Reports of Adverse Effects	Weekly for 7 weeks	Reports of adverse events were completed at baseline and weekly visits throughout the trial.
Rates of Smoking Cessation	Weekly for 7 weeks	Varenicline has efficacy in smoking sensation; therefore smoking cessation was measured at baseline and at all study visits.
Exhaled CO Levels	Weekly over 7 weeks	At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read.
ADHD Clinical Global Impressions Scale Improvement (CGI-I) and Severity (CGI-S)	Weekly for 7 weeks	The Clinical Global Impression Scale of ADHD for Improvement and Severity assess overall severity and change in severity of ADHD. The CGI-I scale is rated from 1 to 7 (1=very much improved; 7=very much worse). The CGI-S is rated from 1 to 7 as well (1=not ill; 7=extremely ill).
Vital Signs	Weekly for 7 weeks	Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate.