Trial Outcomes & Findings for Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT00907218)
NCT ID: NCT00907218
Last Updated: 2017-10-20
Results Overview
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.
TERMINATED
PHASE4
2 participants
Weekly for 7 weeks
2017-10-20
Participant Flow
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.
Recruitment was extremely slow and therefore the study was terminated early
Participant milestones
| Measure |
Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper
Varenicline (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
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|---|---|
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Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
No Data Was Analyzed
n=2 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weekly for 7 weeksPopulation: Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weekly for 7 weeksPopulation: Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weekly over 7 weeksPopulation: Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed
At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weekly for 7 weeksPopulation: Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed
Varenicline has efficacy in smoking sensation; therefore smoking cessation was measured at baseline and at all study visits.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weekly for 7 weeksPopulation: Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weekly for 7 weeksPopulation: Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed
Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weekly for 7 weeksPopulation: Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed
Reports of adverse events were completed at baseline and weekly visits throughout the trial.
Outcome measures
Outcome data not reported
Adverse Events
Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place