Status:
COMPLETED
Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study
Lead Sponsor:
Duke University
Collaborating Sponsors:
Shire
Conditions:
Attention Deficit Hyperactivity Disorder
Nicotine Dependence
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 patient...
Detailed Description
This will be a 2-group, parallel, placebo-controlled, double blind study. Regular, nicotine dependent individuals with ADHD will receive NRT pretreatment for 2 weeks prior to an identified quit date.A...
Eligibility Criteria
Inclusion
- 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
- other psychiatric conditions that require medication
- history of cardiovascular disease, clinically significant hypertension
- Body Mass index (BMI) \> 35
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00736255
Start Date
December 1 2007
End Date
July 1 2011
Last Update
November 30 2018
Active Locations (1)
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1
Duke Attention Deficit Hyperactivity Disorder (ADHD) Program
Durham, North Carolina, United States, 27705