Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Attention Deficit Hyperactivity Disorder Nicotine Dependence |
Drug: Lis-dexamphetamine (LDX; Vyvanse) and Transdermal Nicotine Patch Drug: Placebo and transdermal nicotine patch |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Lis-dexamphetamine (LDX/SPD489)as a Treatment for Smoking Cessation in Nicotine Dependent Individuals With ADHD |
- 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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]The primary outcome measure was the proportion of subjects in each treatment group exhibiting sustained, 4-week smoking abstinence, defined as CO levels < 4 ppm for each post-quit study visit. Subjects who dropped from the study for any reason were considered to have lapsed.
- Smoking Rates. Cognitive Function. ADHD Rating Scales at Pre and Post Quit Period [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | December 2007 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
|
Drug: Lis-dexamphetamine (LDX; Vyvanse) and Transdermal Nicotine Patch
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. All subjects will continue to receive transdermal nicotine patch during these weeks. The dose will be tapered down from 21 mg to 14mg after week 1,then to 7 mg after week 2. Subjects will remain at 7mg until the 4th week.
Other Name: Vyvanse
|
|
Placebo Comparator: 2
The second group will receive matching placebo and NRT after the quit date.
|
Drug: Placebo and transdermal nicotine patch
Subjects on this arm will receive matching placebo and NRT.
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, North Carolina | |
| Duke Attention Deficit Hyperactivity Disorder (ADHD) Program | |
| Durham, North Carolina, United States, 27705 | |
| Principal Investigator: | Scott H Kollins, PhD | Duke University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00736255 History of Changes |
| Other Study ID Numbers: | 00001248, SPD489-607 |
| Study First Received: | August 13, 2008 |
| Results First Received: | August 17, 2011 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Duke University:
|
ADHD Smoking |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Smoking Attention Deficit Disorder with Hyperactivity Hyperkinesis Substance-Related Disorders Mental Disorders Habits Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Dextroamphetamine Nicotine polacrilex |
Nicotine Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Nicotinic Agonists |
ClinicalTrials.gov processed this record on May 22, 2013