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

NCT00907218 | Terminated Phase 4 Results

• 1 other identifier: 2009-P-000444
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

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

  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.

  Weekly for 7 weeks

• Time Line Follow Back of Cigarette Smoking

  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.

  Weekly for 7 weeks

Secondary Outcomes (5)

• Exhaled CO Levels

  Weekly over 7 weeks

• Rates of Smoking Cessation

  Weekly for 7 weeks

• ADHD Clinical Global Impressions Scale Improvement (CGI-I) and Severity (CGI-S)

  Weekly for 7 weeks

• Vital Signs

  Weekly for 7 weeks

• Spontaneous Reports of Adverse Effects

  Weekly for 7 weeks

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Varenicline (Chantix)

Interventions

Varenicline (Chantix) 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.

Also known as: Chantix(varenicline) is a smoking cessation medicine.

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Smoking Cessation; Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

Extremely slow enrollment so the study was terminated early.

Results Point of Contact

• Title: Dr. Timothy Wilens
• Organization: MassGH

twilens@partners.org

617-724-5226

Study Officials

• Timothy Wilens, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 22, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 20, 2017
• Results First Posted: September 23, 2013

Record last verified: 2017-09