Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study
Condition: Attention Deficit Hyperactivity Disorder; Nicotine Dependence
MeSH terms: Hyperkinesis; Tobacco Use Disorder; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

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.
    

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.At the quit date, subjects will be randomized into one of two groups.

        -  The first group will begin treatment for 1 week with LDX 30 mg and then will be titrated
           up to 50mg and 70mg if tolerated. Subjects will continue on the highest tolerated dose
           until the 4th week. Concurrently subjects will receive transdermal NRT, 21 mg at week
           one, 14 mg at week 2 and 7 mg at weeks 3 and 4.

        -  The second group will receive matching placebo and transdermal NRT after the quit date.

      Participants will attend a total of 16 visits over a period of 7-11 weeks. The primary
      outcome measure for this study will be the proportion of individuals in each group who report
      4 weeks continuous smoking abstinence verified by both Carbon Monoxide (CO) levels and
      salivary cotinine, measured at Visit 5. It is hypothesized that the group co-treated with LDX
      will have a significantly higher proportion of individuals who remain abstinent across the 4
      weeks measured every other day.

      Inclusion Criteria:

        -  Aged 18-50 years

        -  Meet DSM-IV criteria (Diagnostic and Statistical manual of mental Disorders Version 4)
           for ADHD, any subtype; assessed using the Conners Adult ADHD Interview for DSM (CAADID)

        -  Meet DSM-IV criteria for nicotine dependence as verified by afternoon expired CO levels
           of >15 parts per million (PPM) and self-report of smoking >10 cigarettes/day

        -  Free from major medical problems and deemed healthy by the study physician

        -  Not currently receiving medication for ADHD or other psychiatric disorders. If a patient
           is screened as is currently receiving medication for ADHD, they may be enrolled,
           provided they washout of their current medication for an appropriate length of time.

        -  No contraindications for treatment with either LDX or transdermal nicotine

      Exclusion Criteria:

        -  DSM-IV Axis I or Axis II disorders that require additional pharmacological treatment or
           otherwise would interfere with participation in the present study

        -  History of known cardiovascular disease, clinically significant hypertension, or other
           cardiovascular risk factors which, in the opinion of the study physician, would
           contraindicate treatment

        -  BMI (Body Mass Index) > 35
    

Intervention name(s): Transdermal Nicotine Patch; Lis-dexamphetamine (Vyvanse); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All subjects will lreceive transdermal nicotine patch during beginning at Visit 0 (quit smoke date). The dose will be tapered down from 21 mg to 14mg after week 1,vthen to 7 mg after week 2. Subjects will remain at 7mg until the 4th week.; 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.; Subjects on this arm will receive matching placebo, along with Nicotine Replacement Therapy.
Other intervention name(s): Nicotine Patch; LDX and Transdermal Nicotine Patch; Placebo and Transdermal Nicotine Patch
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Dextroamphetamine; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Smoking