Trial · NCT00736255

Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study

NCT00736255, Not applicable, Completed, Duke University; results first posted 2012-09-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study. Trials, record NCT00736255. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00736255

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study
NCT number: NCT00736255
Status: Completed
Phases: Not applicable
Enrollment: 32 participants, actual
Lead sponsor: Duke University
Conditions: Attention Deficit Hyperactivity Disorder, Nicotine Dependence
Interventions: Transdermal Nicotine Patch, Lis-dexamphetamine (Vyvanse), Placebo
First posted: 2008-08-15
Last updated: 2018-11-30
Results first posted: 2012-09-07
Limitations and caveats: Limitations of the study: 1. Our sample size was quite small and this can realistically only be considered a pilot trial. 2.We did not collect systematic follow-up data on our sample after the end of treatment.3.the duration of our trial was short.

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.	4 weeks	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.
Secondary	Smoking Rates	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.
Secondary	Continuous Performance Test (CPT) Commission Errors	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.
Secondary	Continuous Performance Test (CPT) Reaction Time Standard Error	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.
Secondary	ADHD Conners' Adult ADHD Rating Scales (CAARS) Self-Report and Observer Short Forms	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)
Secondary	N-back Test Proportion Correct Across 4 Load Factors	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.
Secondary	Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I)	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.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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.	4 weeks	Subjects exhibiting sustained 4 week smoking abstinence defined as CO levels \<= 4ppm for each post quit study visit were analyzed for the outcome measure.	participants	NUMBER
SECONDARY	Smoking Rates	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)		Cigarettes smoked per day	MEAN
SECONDARY	Continuous Performance Test (CPT) Commission Errors	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)		Errors of Commission	MEAN
SECONDARY	Continuous Performance Test (CPT) Reaction Time Standard Error	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)		Reaction time in seconds	MEAN
SECONDARY	ADHD Conners' Adult ADHD Rating Scales (CAARS) Self-Report and Observer Short Forms	Randomization, Visits 2 (day 7), 4 (day 14), 6 (day 21), 8 (day 28)		T-score on a scale	MEAN
SECONDARY	N-back Test Proportion Correct Across 4 Load Factors	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)		proportion correct to stimuli response	MEAN
SECONDARY	Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I)	Visits 2 (day 7), 4 (day 14), 6 (day 21), 8 (day 28)		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group146

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
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.	LDX and NRT		5		participants
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.	NRT and Placebo		3		participants
Smoking Rates	LDX and NRT	Randomization (Visit 0)	6.43	Standard Error 1.38	Cigarettes smoked per day
Smoking Rates	NRT and Placebo	Randomization (Visit 0)	8.14	Standard Error 1.79	Cigarettes smoked per day
Smoking Rates	LDX and NRT	Visit 1 (day 4)	3.90	Standard Error 1.28	Cigarettes smoked per day
Smoking Rates	NRT and Placebo	Visit 1 (day 4)	2.59	Standard Error 1.02	Cigarettes smoked per day
Smoking Rates	LDX and NRT	Visit 2 (day 7)	3.16	Standard Error 1.10	Cigarettes smoked per day
Smoking Rates	NRT and Placebo	Visit 2 (day 7)	1.83	Standard Error 0.84	Cigarettes smoked per day
Smoking Rates	LDX and NRT	Visit 3 (day 11)	2.75	Standard Error 1.12	Cigarettes smoked per day
Smoking Rates	NRT and Placebo	Visit 3 (day 11)	2.23	Standard Error 0.94	Cigarettes smoked per day

1 to 10 of 146Source ClinicalTrials.gov

See all 146 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	LDX and NRT	17
Overall Study	STARTED	NRT and Placebo	15
Overall Study	COMPLETED	LDX and NRT	14
Overall Study	COMPLETED	NRT and Placebo	14
Overall Study	NOT COMPLETED	LDX and NRT	3
Overall Study	NOT COMPLETED	NRT and Placebo	1

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anxiety	Psychiatric disorders	LDX and NRT	1	17	1
other	Anxiety	Psychiatric disorders	NRT and Placebo	2	15	2
other	Acne	Skin and subcutaneous tissue disorders	LDX and NRT	1	17	1
other	Acne	Skin and subcutaneous tissue disorders	NRT and Placebo	0	15	0
other	Restlessness	Psychiatric disorders	LDX and NRT	0	17	0
other	Restlessness	Psychiatric disorders	NRT and Placebo	1	15	1
other	Inability to concentrate	Psychiatric disorders	LDX and NRT	0	17	0
other	Inability to concentrate	Psychiatric disorders	NRT and Placebo	1	15	1
other	Irritability	Psychiatric disorders	LDX and NRT	3	17	3
other	Irritability	Psychiatric disorders	NRT and Placebo	1	15	1

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LDX and NRT
Total, all-cause mortality	NRT and Placebo
Total, other adverse events	LDX and NRT	15	17
Total, other adverse events	NRT and Placebo	12	15
Total, serious adverse events	LDX and NRT	0	17
Total, serious adverse events	NRT and Placebo	0	15

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
LDX and NRT vs NRT and Placebo: 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.	Trial comparisons
LDX and NRT vs NRT and Placebo: serious adverse events	Trial comparisons

Tests3

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
1-Back Task	Secondary outcome	ConductCognition
2-Back Task	Secondary outcome	ConductCognition
Continuous Performance Test	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00736255

GET https://conductscience.org/api/trials/v1/NCT00736255/results?page=2

API reference For AI assistants