Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study

NCT ID: NCT00736255

Last Updated: 2018-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2011-07-31

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 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

Conditions

Attention Deficit Hyperactivity Disorder; Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vyvanse and transdermal nicotine patch

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.

Group Type: EXPERIMENTAL

Transdermal Nicotine Patch

Intervention Type: DRUG

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.

Lis-dexamphetamine (Vyvanse)

Intervention Type: DRUG

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.

Placebo and transdermal nicotine patch

The second group will receive matching placebo and NRT after the quit date.

Group Type: PLACEBO_COMPARATOR

Transdermal Nicotine Patch

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Subjects on this arm will receive matching placebo, along with Nicotine Replacement Therapy.

Interventions

Transdermal Nicotine Patch

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.

Intervention Type: DRUG

Lis-dexamphetamine (Vyvanse)

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.

Intervention Type: DRUG

Placebo

Subjects on this arm will receive matching placebo, along with Nicotine Replacement Therapy.

Intervention Type: DRUG

Other Intervention Names

Nicotine Patch; LDX and Transdermal Nicotine Patch; Placebo and Transdermal Nicotine Patch

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shire

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott H Kollins, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Attention Deficit Hyperactivity Disorder (ADHD) Program

Durham, North Carolina, United States

Countries

United States

Other Identifiers

SPD489-607

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00001248

Identifier Type: -

Identifier Source: org_study_id