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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit/Hyperactivity Disorder; Smoking Cessation

Intervention: Varenicline (Chantix) (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Timothy Wilens, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

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.

Clinical Details

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 design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The DSM-IV Based Adult ADHD Investigator Symptom Rating Scale (AISRS)

Time Line Follow Back of Cigarette Smoking

Secondary outcome:

Exhaled CO Levels

Rates of Smoking Cessation

The CGI-I and CGI-S for ADHD

Vital Signs

Spontaneous Reports of Adverse Effects

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: April 2009
Last updated: July 31, 2013

Page last updated: August 23, 2015

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