Trial Outcomes & Findings for Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study (NCT NCT00736255)
NCT ID: NCT00736255
Last Updated: 2018-11-30
Results Overview
The primary outcome measure was the proportion of subjects in each treatment group exhibiting sustained, 4-week smoking abstinence, defined as CO levels \<= 4 ppm for each post-quit study visit. Subjects who dropped from the study for any reason were considered to have lapsed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
4 weeks
Results posted on
2018-11-30
Participant Flow
Recruitment ended in March 2011 at the Duke.A total of 59 subjects were screened. 24 did not pass screening while 35 were eligible. Of the 35 screen passers, 32 were randomized to receive either LDX or placebo, 3 were withdrawn prior to randomization. Of the 32 randomized, 17 received LDX and 15 received placebo. 14 completed on each arm.
There were 24 screen fails. Reason for Screen Fails include:Did not complete screening - 2,Carbon monoxide too low - 3,Positive Urine drug screen - 3,Physical health reasons - 5,Psychiatric comorbidity - 11
Participant milestones
| Measure |
LDX and NRT
• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
|
NRT and Placebo
The second group will receive matching placebo and NRT after the quit date.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
LDX and NRT
• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
|
NRT and Placebo
The second group will receive matching placebo and NRT after the quit date.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Non-compliance
|
1
|
1
|
Baseline Characteristics
Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study
Baseline characteristics by cohort
| Measure |
LDX and NRT
n=17 Participants
• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
|
NRT and Placebo
n=15 Participants
The second group will receive matching placebo and NRT after the quit date.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 8.4 • n=93 Participants
|
33.5 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
31 years
STANDARD_DEVIATION 8.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
15 participants
n=4 Participants
|
32 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Subjects exhibiting sustained 4 week smoking abstinence defined as CO levels \<= 4ppm for each post quit study visit were analyzed for the outcome measure.
The primary outcome measure was the proportion of subjects in each treatment group exhibiting sustained, 4-week smoking abstinence, defined as CO levels \<= 4 ppm for each post-quit study visit. Subjects who dropped from the study for any reason were considered to have lapsed.
Outcome measures
| Measure |
LDX and NRT
n=17 Participants
• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
Lis-dexamphetamine (LDX; Vyvanse) and Transdermal Nicotine Patch: Subjects on this arm will receive Lis-dexamphetamine day after the identified quit date. All subject will start with 30mg once a day and will be titrated up to 50mg then to 70mg over a 3 week period to reach an optimized dose. They will then be maintained on this optimized dose until the 4th week. All subjects will continue to receive transdermal nicotine patch during these weeks. The dose will be tapered down from 21 mg to 14mg after week 1,then to 7 mg after week 2. Subjects will remain at 7mg until the 4th week.
|
NRT and Placebo
n=15 Participants
The second group will receive matching placebo and NRT after the quit date.
Placebo and transdermal nicotine patch: Subjects on this arm will receive matching placebo and NRT.
|
|---|---|---|
|
The Number of Subjects in Each Treatment Group Exhibiting Sustained, 4-week Smoking Abstinence, Defined as CO Levels <= 4 Ppm for Each Post-quit Study Visit.
|
5 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Randomization, visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)Smoking rates, measured as self-reported cigarettes/day.
Outcome measures
| Measure |
LDX and NRT
n=17 Participants
• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
Lis-dexamphetamine (LDX; Vyvanse) and Transdermal Nicotine Patch: Subjects on this arm will receive Lis-dexamphetamine day after the identified quit date. All subject will start with 30mg once a day and will be titrated up to 50mg then to 70mg over a 3 week period to reach an optimized dose. They will then be maintained on this optimized dose until the 4th week. All subjects will continue to receive transdermal nicotine patch during these weeks. The dose will be tapered down from 21 mg to 14mg after week 1,then to 7 mg after week 2. Subjects will remain at 7mg until the 4th week.
|
NRT and Placebo
n=15 Participants
The second group will receive matching placebo and NRT after the quit date.
Placebo and transdermal nicotine patch: Subjects on this arm will receive matching placebo and NRT.
|
|---|---|---|
|
Smoking Rates
Randomization (Visit 0)
|
6.43 Cigarettes smoked per day
Standard Error 1.38
|
8.14 Cigarettes smoked per day
Standard Error 1.79
|
|
Smoking Rates
Visit 1 (day 4)
|
3.90 Cigarettes smoked per day
Standard Error 1.28
|
2.59 Cigarettes smoked per day
Standard Error 1.02
|
|
Smoking Rates
Visit 2 (day 7)
|
3.16 Cigarettes smoked per day
Standard Error 1.10
|
1.83 Cigarettes smoked per day
Standard Error 0.84
|
|
Smoking Rates
Visit 3 (day 11)
|
2.75 Cigarettes smoked per day
Standard Error 1.12
|
2.23 Cigarettes smoked per day
Standard Error 0.94
|
|
Smoking Rates
Visit 4 (day 14)
|
2.98 Cigarettes smoked per day
Standard Error 1.31
|
2.10 Cigarettes smoked per day
Standard Error 0.74
|
|
Smoking Rates
Visit 5 (day 18)
|
3.08 Cigarettes smoked per day
Standard Error 1.45
|
2.92 Cigarettes smoked per day
Standard Error 1.00
|
|
Smoking Rates
Visit 6 (day 21)
|
3.94 Cigarettes smoked per day
Standard Error 1.59
|
2.67 Cigarettes smoked per day
Standard Error 0.98
|
|
Smoking Rates
Visit 7 (day 25)
|
4.38 Cigarettes smoked per day
Standard Error 1.69
|
2.33 Cigarettes smoked per day
Standard Error 0.84
|
|
Smoking Rates
Visit 8 (day 28)
|
4.15 Cigarettes smoked per day
Standard Error 1.58
|
2.91 Cigarettes smoked per day
Standard Error 1.07
|
SECONDARY outcome
Timeframe: Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors - measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.
Outcome measures
| Measure |
LDX and NRT
n=17 Participants
• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
Lis-dexamphetamine (LDX; Vyvanse) and Transdermal Nicotine Patch: Subjects on this arm will receive Lis-dexamphetamine day after the identified quit date. All subject will start with 30mg once a day and will be titrated up to 50mg then to 70mg over a 3 week period to reach an optimized dose. They will then be maintained on this optimized dose until the 4th week. All subjects will continue to receive transdermal nicotine patch during these weeks. The dose will be tapered down from 21 mg to 14mg after week 1,then to 7 mg after week 2. Subjects will remain at 7mg until the 4th week.
|
NRT and Placebo
n=15 Participants
The second group will receive matching placebo and NRT after the quit date.
Placebo and transdermal nicotine patch: Subjects on this arm will receive matching placebo and NRT.
|
|---|---|---|
|
Continuous Performance Test (CPT) Commission Errors
Randomization (Visit 0)
|
15.29 Errors of Commission
Standard Deviation 10.58
|
12.43 Errors of Commission
Standard Deviation 9.37
|
|
Continuous Performance Test (CPT) Commission Errors
Visit 1 (day 4)
|
13.29 Errors of Commission
Standard Deviation 9.64
|
10.71 Errors of Commission
Standard Deviation 8.62
|
|
Continuous Performance Test (CPT) Commission Errors
Visit 2 (day 7)
|
13.44 Errors of Commission
Standard Deviation 9.14
|
10.86 Errors of Commission
Standard Deviation 8.70
|
|
Continuous Performance Test (CPT) Commission Errors
Visit 3 (day 11)
|
14.50 Errors of Commission
Standard Deviation 8.91
|
10.79 Errors of Commission
Standard Deviation 7.52
|
|
Continuous Performance Test (CPT) Commission Errors
Visit 4 (day 14)
|
13.13 Errors of Commission
Standard Deviation 8.33
|
11.08 Errors of Commission
Standard Deviation 9.29
|
|
Continuous Performance Test (CPT) Commission Errors
Visit 5 (day 18)
|
15.00 Errors of Commission
Standard Deviation 7.67
|
11.15 Errors of Commission
Standard Deviation 9.20
|
|
Continuous Performance Test (CPT) Commission Errors
Visit 6 (day 21)
|
12.36 Errors of Commission
Standard Deviation 10.43
|
12.15 Errors of Commission
Standard Deviation 8.12
|
|
Continuous Performance Test (CPT) Commission Errors
Visit 7 (day 25)
|
14.64 Errors of Commission
Standard Deviation 9.20
|
11.77 Errors of Commission
Standard Deviation 6.98
|
|
Continuous Performance Test (CPT) Commission Errors
Visit 8 (day 28)
|
14.92 Errors of Commission
Standard Deviation 10.80
|
11.23 Errors of Commission
Standard Deviation 9.77
|
SECONDARY outcome
Timeframe: Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors - measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.
Outcome measures
| Measure |
LDX and NRT
n=17 Participants
• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
Lis-dexamphetamine (LDX; Vyvanse) and Transdermal Nicotine Patch: Subjects on this arm will receive Lis-dexamphetamine day after the identified quit date. All subject will start with 30mg once a day and will be titrated up to 50mg then to 70mg over a 3 week period to reach an optimized dose. They will then be maintained on this optimized dose until the 4th week. All subjects will continue to receive transdermal nicotine patch during these weeks. The dose will be tapered down from 21 mg to 14mg after week 1,then to 7 mg after week 2. Subjects will remain at 7mg until the 4th week.
|
NRT and Placebo
n=15 Participants
The second group will receive matching placebo and NRT after the quit date.
Placebo and transdermal nicotine patch: Subjects on this arm will receive matching placebo and NRT.
|
|---|---|---|
|
Continuous Performance Test (CPT) Reaction Time Standard Error
Randomization (Visit 0)
|
5.37 Reaction time in seconds
Standard Deviation 1.93
|
4.61 Reaction time in seconds
Standard Deviation 1.31
|
|
Continuous Performance Test (CPT) Reaction Time Standard Error
Visit 1 (day 4)
|
5.52 Reaction time in seconds
Standard Deviation 3.44
|
4.68 Reaction time in seconds
Standard Deviation 1.44
|
|
Continuous Performance Test (CPT) Reaction Time Standard Error
Visit 2 (day 7)
|
5.42 Reaction time in seconds
Standard Deviation 3.45
|
5.05 Reaction time in seconds
Standard Deviation 1.81
|
|
Continuous Performance Test (CPT) Reaction Time Standard Error
Visit 3 (day 11)
|
4.97 Reaction time in seconds
Standard Deviation 2.71
|
5.01 Reaction time in seconds
Standard Deviation 1.46
|
|
Continuous Performance Test (CPT) Reaction Time Standard Error
Visit 4 (day 14)
|
4.83 Reaction time in seconds
Standard Deviation 2.55
|
4.79 Reaction time in seconds
Standard Deviation 1.71
|
|
Continuous Performance Test (CPT) Reaction Time Standard Error
Visit 5 (day 18)
|
5.54 Reaction time in seconds
Standard Deviation 2.77
|
5.15 Reaction time in seconds
Standard Deviation 1.71
|
|
Continuous Performance Test (CPT) Reaction Time Standard Error
Visit 6 (day 21)
|
4.64 Reaction time in seconds
Standard Deviation 2.28
|
4.97 Reaction time in seconds
Standard Deviation 1.62
|
|
Continuous Performance Test (CPT) Reaction Time Standard Error
Visit 7 (day 25)
|
5.29 Reaction time in seconds
Standard Deviation 2.73
|
5.73 Reaction time in seconds
Standard Deviation 2.01
|
|
Continuous Performance Test (CPT) Reaction Time Standard Error
Visit 8 (day 28)
|
4.86 Reaction time in seconds
Standard Deviation 2.23
|
5.08 Reaction time in seconds
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: Randomization, Visits 2 (day 7), 4 (day 14), 6 (day 21), 8 (day 28)T-scores derived from compiled ADHD symptoms from two forms. Specifically the t-scores for the DSM-IV Total subscale, representing ADHD symptoms. This is conducted by the participant and clinician at randomization, visits 2 and 4 (i.e. dose titration visits), Visit 6 (i.e. monitoring visit), and Visit 8 (i.e. final/end of study visit). The following describes severity of the ADHD symptoms (based upon T-Score): 70+ = Very Much Above Average 66-70 = Much Above Average 61-65 = Above Average 56-60 = Slightly Above Average 45-55 = Average 30-44 = Below Average (Low scores are good)
Outcome measures
| Measure |
LDX and NRT
n=17 Participants
• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
Lis-dexamphetamine (LDX; Vyvanse) and Transdermal Nicotine Patch: Subjects on this arm will receive Lis-dexamphetamine day after the identified quit date. All subject will start with 30mg once a day and will be titrated up to 50mg then to 70mg over a 3 week period to reach an optimized dose. They will then be maintained on this optimized dose until the 4th week. All subjects will continue to receive transdermal nicotine patch during these weeks. The dose will be tapered down from 21 mg to 14mg after week 1,then to 7 mg after week 2. Subjects will remain at 7mg until the 4th week.
|
NRT and Placebo
n=15 Participants
The second group will receive matching placebo and NRT after the quit date.
Placebo and transdermal nicotine patch: Subjects on this arm will receive matching placebo and NRT.
|
|---|---|---|
|
ADHD Conners' Adult ADHD Rating Scales (CAARS) Self-Report and Observer Short Forms
Randomization (Visit 0)
|
67.13 T-score on a scale
Standard Deviation 9.75
|
68.08 T-score on a scale
Standard Deviation 7.48
|
|
ADHD Conners' Adult ADHD Rating Scales (CAARS) Self-Report and Observer Short Forms
Visit 2 (day 7)
|
63.07 T-score on a scale
Standard Deviation 11.48
|
64.62 T-score on a scale
Standard Deviation 8.69
|
|
ADHD Conners' Adult ADHD Rating Scales (CAARS) Self-Report and Observer Short Forms
Visit 4 (day 14)
|
58.62 T-score on a scale
Standard Deviation 13.18
|
65.25 T-score on a scale
Standard Deviation 9.85
|
|
ADHD Conners' Adult ADHD Rating Scales (CAARS) Self-Report and Observer Short Forms
Visit 6 (day 21)
|
52.83 T-score on a scale
Standard Deviation 17.07
|
63.42 T-score on a scale
Standard Deviation 12.70
|
|
ADHD Conners' Adult ADHD Rating Scales (CAARS) Self-Report and Observer Short Forms
Visit 8 (day 28)
|
54.00 T-score on a scale
Standard Deviation 15.33
|
61.92 T-score on a scale
Standard Deviation 11.46
|
SECONDARY outcome
Timeframe: Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)This is measured by the N-Back test, a cognitive functioning, including working memory test. The test is designed with 4 Load Factors, where the current stimulus matches the one from 'n' steps back or prior in the sequence. The load factor n is adjusted so there is a 'O-back' (i.e. 'n-0'), '1-back' (i.e. 'n-1'), '2-back' (i.e. 'n-2'), and '3-back' (i.e. 'n-3'). When the correct stimulus appears on the screen, the participant then responds on the computer. Missing the stimulus decreases the proportion correct.
Outcome measures
| Measure |
LDX and NRT
n=17 Participants
• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
Lis-dexamphetamine (LDX; Vyvanse) and Transdermal Nicotine Patch: Subjects on this arm will receive Lis-dexamphetamine day after the identified quit date. All subject will start with 30mg once a day and will be titrated up to 50mg then to 70mg over a 3 week period to reach an optimized dose. They will then be maintained on this optimized dose until the 4th week. All subjects will continue to receive transdermal nicotine patch during these weeks. The dose will be tapered down from 21 mg to 14mg after week 1,then to 7 mg after week 2. Subjects will remain at 7mg until the 4th week.
|
NRT and Placebo
n=15 Participants
The second group will receive matching placebo and NRT after the quit date.
Placebo and transdermal nicotine patch: Subjects on this arm will receive matching placebo and NRT.
|
|---|---|---|
|
N-back Test Proportion Correct Across 4 Load Factors
Randomization (Visit 0) 0-back _%cor
|
0.96 proportion correct to stimuli response
Standard Deviation 0.12
|
1.00 proportion correct to stimuli response
Standard Deviation 0.00
|
|
N-back Test Proportion Correct Across 4 Load Factors
Randomization (Visit 0) 1-back _%cor
|
0.94 proportion correct to stimuli response
Standard Deviation 0.15
|
0.99 proportion correct to stimuli response
Standard Deviation 0.03
|
|
N-back Test Proportion Correct Across 4 Load Factors
Randomization (Visit 0) 2-back _%cor
|
0.96 proportion correct to stimuli response
Standard Deviation 0.08
|
0.95 proportion correct to stimuli response
Standard Deviation 0.09
|
|
N-back Test Proportion Correct Across 4 Load Factors
Randomization (Visit 0) 3-back _%cor
|
0.84 proportion correct to stimuli response
Standard Deviation 0.14
|
0.80 proportion correct to stimuli response
Standard Deviation 0.29
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 1 (day 4) 0-back _%cor
|
0.95 proportion correct to stimuli response
Standard Deviation 0.23
|
1.00 proportion correct to stimuli response
Standard Deviation 0.00
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 1 (day 4) 1-back _%cor
|
0.90 proportion correct to stimuli response
Standard Deviation 0.25
|
0.99 proportion correct to stimuli response
Standard Deviation 0.02
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 1 (day 4) 2-back _%cor
|
0.89 proportion correct to stimuli response
Standard Deviation 0.27
|
0.96 proportion correct to stimuli response
Standard Deviation 0.09
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 1 (day 4) 3-back _%cor
|
0.80 proportion correct to stimuli response
Standard Deviation 0.31
|
0.83 proportion correct to stimuli response
Standard Deviation 0.18
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 2 (day 7) 0-back _%cor
|
0.93 proportion correct to stimuli response
Standard Deviation 0.26
|
0.92 proportion correct to stimuli response
Standard Deviation 0.27
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 2 (day 7) 1-back _%cor
|
0.90 proportion correct to stimuli response
Standard Deviation 0.26
|
0.95 proportion correct to stimuli response
Standard Deviation 0.11
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 2 (day 7) 2-back _%cor
|
0.86 proportion correct to stimuli response
Standard Deviation 0.30
|
0.92 proportion correct to stimuli response
Standard Deviation 0.13
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 2 (day 7) 3-back _%cor
|
0.81 proportion correct to stimuli response
Standard Deviation 0.28
|
0.81 proportion correct to stimuli response
Standard Deviation 0.27
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 3 (day 11) 0-back _%cor
|
0.89 proportion correct to stimuli response
Standard Deviation 0.27
|
0.99 proportion correct to stimuli response
Standard Deviation 0.02
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 3 (day 11) 1-back _%cor
|
0.89 proportion correct to stimuli response
Standard Deviation 0.28
|
0.99 proportion correct to stimuli response
Standard Deviation 0.02
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 3 (day 11) 2-back _%cor
|
0.89 proportion correct to stimuli response
Standard Deviation 0.27
|
0.95 proportion correct to stimuli response
Standard Deviation 0.10
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 3 (day 11) 3-back _%cor
|
0.84 proportion correct to stimuli response
Standard Deviation 0.30
|
0.90 proportion correct to stimuli response
Standard Deviation 0.14
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 4 (day 14) 0-back _%cor
|
0.93 proportion correct to stimuli response
Standard Deviation 0.26
|
0.99 proportion correct to stimuli response
Standard Deviation 0.02
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 4 (day 14) 1-back _%cor
|
0.91 proportion correct to stimuli response
Standard Deviation 0.26
|
0.99 proportion correct to stimuli response
Standard Deviation 0.03
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 4 (day 14) 2-back _%cor
|
0.90 proportion correct to stimuli response
Standard Deviation 0.25
|
0.95 proportion correct to stimuli response
Standard Deviation 0.12
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 4 (day 14) 3-back _%cor
|
0.90 proportion correct to stimuli response
Standard Deviation 0.25
|
0.89 proportion correct to stimuli response
Standard Deviation 0.15
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 5 (day 18) 0-back _%cor
|
1.00 proportion correct to stimuli response
Standard Deviation 0.00
|
0.99 proportion correct to stimuli response
Standard Deviation 0.03
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 5 (day 18) 1-back _%cor
|
0.98 proportion correct to stimuli response
Standard Deviation 0.08
|
0.99 proportion correct to stimuli response
Standard Deviation 0.02
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 5 (day 18) 2-back _%cor
|
0.99 proportion correct to stimuli response
Standard Deviation 0.02
|
0.98 proportion correct to stimuli response
Standard Deviation 0.08
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 5 (day 18) 3-back _%cor
|
0.88 proportion correct to stimuli response
Standard Deviation 0.16
|
0.92 proportion correct to stimuli response
Standard Deviation 0.16
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 6 (day 21) 0-back _%cor
|
0.93 proportion correct to stimuli response
Standard Deviation 0.27
|
1.00 proportion correct to stimuli response
Standard Deviation 0.00
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 6 (day 21) 1-back _%cor
|
0.93 proportion correct to stimuli response
Standard Deviation 0.27
|
0.98 proportion correct to stimuli response
Standard Deviation 0.03
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 6 (day 21) 2-back _%cor
|
0.90 proportion correct to stimuli response
Standard Deviation 0.26
|
0.96 proportion correct to stimuli response
Standard Deviation 0.09
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 6 (day 21) 3-back _%cor
|
0.89 proportion correct to stimuli response
Standard Deviation 0.26
|
0.87 proportion correct to stimuli response
Standard Deviation 0.15
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 7 (day 25) 0-back _%cor
|
0.99 proportion correct to stimuli response
Standard Deviation 0.03
|
0.99 proportion correct to stimuli response
Standard Deviation 0.04
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 7 (day 25)1-back _%cor
|
0.99 proportion correct to stimuli response
Standard Deviation 0.03
|
0.99 proportion correct to stimuli response
Standard Deviation 0.03
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 7 (day 25) 2-back _%cor
|
0.97 proportion correct to stimuli response
Standard Deviation 0.07
|
0.95 proportion correct to stimuli response
Standard Deviation 0.12
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 7 (day 25) 3-back _%cor
|
0.91 proportion correct to stimuli response
Standard Deviation 0.11
|
0.88 proportion correct to stimuli response
Standard Deviation 0.15
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 8 (day 28) 0-back _%cor
|
0.93 proportion correct to stimuli response
Standard Deviation 0.23
|
0.99 proportion correct to stimuli response
Standard Deviation 0.02
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 8 (day 28) 1-back _%cor
|
0.98 proportion correct to stimuli response
Standard Deviation 0.03
|
0.98 proportion correct to stimuli response
Standard Deviation 0.05
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 8 (day 28) 2-back _%cor
|
0.92 proportion correct to stimuli response
Standard Deviation 0.27
|
0.95 proportion correct to stimuli response
Standard Deviation 0.09
|
|
N-back Test Proportion Correct Across 4 Load Factors
Visit 8 (day 28) 3-back _%cor
|
0.91 proportion correct to stimuli response
Standard Deviation 0.13
|
0.84 proportion correct to stimuli response
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Visits 2 (day 7), 4 (day 14), 6 (day 21), 8 (day 28)Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. 1-Very Much Improved through 7-Very Much Worse.
Outcome measures
| Measure |
LDX and NRT
n=17 Participants
• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
Lis-dexamphetamine (LDX; Vyvanse) and Transdermal Nicotine Patch: Subjects on this arm will receive Lis-dexamphetamine day after the identified quit date. All subject will start with 30mg once a day and will be titrated up to 50mg then to 70mg over a 3 week period to reach an optimized dose. They will then be maintained on this optimized dose until the 4th week. All subjects will continue to receive transdermal nicotine patch during these weeks. The dose will be tapered down from 21 mg to 14mg after week 1,then to 7 mg after week 2. Subjects will remain at 7mg until the 4th week.
|
NRT and Placebo
n=15 Participants
The second group will receive matching placebo and NRT after the quit date.
Placebo and transdermal nicotine patch: Subjects on this arm will receive matching placebo and NRT.
|
|---|---|---|
|
Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I)
Visit 2 (day 7) CGI-I
|
2.88 score on a scale
Standard Deviation 0.89
|
3.50 score on a scale
Standard Deviation 0.76
|
|
Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I)
Visit 4 (day 14) CGI-I
|
2.73 score on a scale
Standard Deviation 1.03
|
3.38 score on a scale
Standard Deviation 0.77
|
|
Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I)
Visit 6 (day 21) CGI_I
|
2.29 score on a scale
Standard Deviation 1.20
|
3.31 score on a scale
Standard Deviation 1.18
|
|
Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I)
Visit 8 (day 28) CGI-I
|
2.00 score on a scale
Standard Deviation 1.24
|
3.15 score on a scale
Standard Deviation 0.99
|
Adverse Events
LDX and NRT
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
NRT and Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LDX and NRT
n=17 participants at risk
• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
|
NRT and Placebo
n=15 participants at risk
The second group will receive matching placebo and NRT after the quit date.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.9%
1/17 • Number of events 1
|
0.00%
0/15
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/17
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
Inability to concentrate
|
0.00%
0/17
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
Irritability
|
17.6%
3/17 • Number of events 3
|
6.7%
1/15 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Panic Attack
|
0.00%
0/17
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
Nightmares/Dreams
|
17.6%
3/17 • Number of events 3
|
20.0%
3/15 • Number of events 3
|
|
Psychiatric disorders
Increased Appetite
|
5.9%
1/17 • Number of events 1
|
0.00%
0/15
|
|
Psychiatric disorders
Decreased Appetite
|
35.3%
6/17 • Number of events 6
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Excessive Thirst
|
5.9%
1/17 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chest tightness
|
5.9%
1/17 • Number of events 1
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Muscle twitches
|
5.9%
1/17 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Stomach ache
|
5.9%
1/17 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arm Pain
|
5.9%
1/17 • Number of events 1
|
0.00%
0/15
|
|
Psychiatric disorders
Bruxism
|
11.8%
2/17 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/17
|
13.3%
2/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
0.00%
0/17
|
13.3%
2/15 • Number of events 2
|
|
Nervous system disorders
Shaking hands/Tremor
|
0.00%
0/17
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Insomnia
|
5.9%
1/17 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Nervous system disorders
Headache
|
23.5%
4/17 • Number of events 4
|
13.3%
2/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Nausea
|
23.5%
4/17 • Number of events 4
|
40.0%
6/15 • Number of events 6
|
|
General disorders
Chills
|
0.00%
0/17
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin irritation at NRT patch site
|
5.9%
1/17 • Number of events 1
|
46.7%
7/15 • Number of events 7
|
|
General disorders
Dry mouth
|
11.8%
2/17 • Number of events 2
|
0.00%
0/15
|
|
Endocrine disorders
Metallic Taste
|
5.9%
1/17 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place