N/A
N=32
Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study
Attention Deficit Hyperactivity Disorder · Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00736255 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: 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. — 5; 3 participants — p=0.54
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transdermal Nicotine Patch (Drug); Lis-dexamphetamine (Vyvanse) (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
5; 3 | 0.54 |
| SECONDARY Smoking Rates |
6.43; 8.14; 3.90; 2.59; 3.16; 1.83 | — |
| SECONDARY Continuous Performance Test (CPT) Commission Errors |
15.29; 12.43; 13.29; 10.71; 13.44; 10.86 | — |
| SECONDARY Continuous Performance Test (CPT) Reaction Time Standard Error |
5.37; 4.61; 5.52; 4.68; 5.42; 5.05 | — |
| SECONDARY ADHD Conners' Adult ADHD Rating Scales (CAARS) Self-Report and Observer Short Forms |
67.13; 68.08; 63.07; 64.62; 58.62; 65.25 | — |
| SECONDARY N-back Test Proportion Correct Across 4 Load Factors |
0.96; 1.00; 0.94; 0.99; 0.96; 0.95 | — |
| SECONDARY Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I) |
2.88; 3.50; 2.73; 3.38; 2.29; 3.31 | — |
Summary
The overall goal of the present project is to investigate whether lisdexamphetamine (LDX; Vyvanse) is an effective adjunct to nicotine replacement therapy (NRT) to promote smoking cessation in patients with comorbid Attention Deficit Hyperactivity Disorder (ADHD) and nicotine dependence. The investigators hypothesized initially that smokers with ADHD who are optimized to a dose of LDX prior to quitting smoking and who remain on this dose of medication after quitting will remain abstinent longer than patients who are treated with placebo before and after quitting.However due to recent key issues that have arisen showing that initiation of stimulant treatment while subjects are actively smoking may facilitate increased smoking, and given that the study was still in the very early stage of study execution, the investigators revised the study design to use an empirically validated pretreatment approach with NRT and to initiate LDX treatment on the first post quit date in order to reduce the withdrawal symptoms that accompany smoking cessation. The overall rationale for this revised study design remains similar to the original.
Eligibility Criteria
Inclusion Criteria
- Attention Deficit Hyperactivity Disorder(ADHD) diagnosis
- smokes at least > 10 cigarettes per day
- no major medical problems
- no contraindications to treatment with either LDX or transdermal nicotine
Exclusion Criteria
- other psychiatric conditions that require medication
- history of cardiovascular disease, clinically significant hypertension
- Body Mass index (BMI) > 35
Data sourced from ClinicalTrials.gov (NCT00736255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.