Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00736255
First received: August 13, 2008
Last updated: May 21, 2013
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736255

Locations
United States, North Carolina
Duke Attention Deficit Hyperactivity Disorder (ADHD) Program
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Shire
Investigators
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: Pro00001248, SPD489-607
Study First Received: August 13, 2008
Results First Received: August 17, 2011
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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 July 23, 2014