Clinical trial NCT00907218: Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: An Open Pilot Study of Varenicline (Chantix) in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD): Effects on ADHD and Cigarette Smoking
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Attention Deficit/Hyperactivity Disorder
Smoking Cessation
Keywords: ADHD
Attention Deficit Hyperactivity Disorder
ADHD medication
Chantix
varenicline
smoking
smoking cessation
quit smoking
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2009-05-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The DSM-IV Based Adult ADHD Investigator Symptom Rating Scale (AISRS)
timeFrame: Weekly for 7 weeks
measure: Time Line Follow Back of Cigarette Smoking
timeFrame: Weekly for 7 weeks
Secondary outcomes:
measure: Exhaled CO Levels
timeFrame: Weekly over 7 weeks
measure: Rates of Smoking Cessation
timeFrame: Weekly for 7 weeks
measure: ADHD Clinical Global Impressions Scale Improvement (CGI-I) and Severity (CGI-S)
timeFrame: Weekly for 7 weeks
measure: Vital Signs
timeFrame: Weekly for 7 weeks
measure: Spontaneous Reports of Adverse Effects
timeFrame: Weekly for 7 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Timothy Wilens, MD
role: PRINCIPAL_INVESTIGATOR
References: