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

An Open Pilot Study of Varenicline (Chantix) in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD): Effects on ADHD and Cigarette Smoking

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00907218

Enrollment

Registered

2009-05-22

Start date

2009-04-30

Completion date

2010-05-31

Last updated

2017-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit/Hyperactivity Disorder, Smoking Cessation

Keywords

ADHD, Attention Deficit Hyperactivity Disorder, ADHD medication, Chantix, varenicline, smoking, smoking cessation, quit smoking

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.

Interventions

DRUGVarenicline (Chantix)

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).
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.
Spontaneous Reports of Adverse Effects	Weekly for 7 weeks	Reports of adverse events were completed at baseline and weekly visits throughout the trial.
Vital Signs	Weekly for 7 weeks	Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate.
Exhaled CO Levels	Weekly over 7 weeks	At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read.

Participant flow

Recruitment details

2 studies were recruited. They participated in a previous study in our department and signed consent for the data to be used for this study.

Pre-assignment details

Recruitment was extremely slow and therefore the study was terminated early

Participants by arm

Arm	Count
No Data Was Analyzed	2
Total	2

Baseline characteristics

Characteristic	No Data Was Analyzed
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	2 Participants
Age, Continuous	37.5 years STANDARD_DEVIATION 17
Region of Enrollment United States	2 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 2
serious Total, serious adverse events	0 / 2

Outcome results

Primary

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.

Time frame: Weekly for 7 weeks