Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
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.