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Comparison · NCT00736255-997448c7

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.

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. 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, record NCT00736255-997448c7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00736255-997448c7

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.2940.1330.531wilson
Risk in group 20.20.07050.452wilson
Risk difference, group 1 minus group 20.0941-0.2050.364newcombe hybrid score
Risk ratio, group 1 over group 21.470.4215.14log
Odds ratio, group 1 over group 21.670.3238.59log
Number needed to treat, for one more participant with the outcome on LDX and NRT than on NRT and Placebo10.6from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1LDX 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.~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.
517OG000
Group 2NRT and PlaceboThe 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.315OG001

Outcome

Type
PRIMARY
Title
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.
Description
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.
Time frame
4 weeks
Population
Subjects exhibiting sustained 4 week smoking abstinence defined as CO levels \<= 4ppm for each post quit study visit were analyzed for the outcome measure.

Source ClinicalTrials.gov

Trial

Title
Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study
NCT number
NCT00736255
Phases
NA
Conditions
Attention Deficit Hyperactivity Disorder, Nicotine Dependence
Interventions
Transdermal Nicotine Patch, Lis-dexamphetamine (Vyvanse), Placebo
Lead sponsor
Duke University
Results first posted
2012-09-07

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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