Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Neurology, Psychiatric, Tobacco Consumers |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 12/2/2018 |
| Start Date: | December 2007 |
| End Date: | July 2011 |
Lis-dexamphetamine (LDX/SPD489)as a Treatment for Smoking Cessation in Nicotine Dependent Individuals With ADHD
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.
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.
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
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
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
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