Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study

NCT00736255 | Completed Results

• 2 other identifiers: Pro00001248SPD489-607
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder; Nicotine Dependence

Keywords

ADHD; Smoking

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  4 weeks

Secondary Outcomes (6)

• Smoking Rates

  Randomization, visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)

• Continuous Performance Test (CPT) Commission Errors

  Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)

• Continuous Performance Test (CPT) Reaction Time Standard Error

  Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)

• ADHD Conners' Adult ADHD Rating Scales (CAARS) Self-Report and Observer Short Forms

  Randomization, Visits 2 (day 7), 4 (day 14), 6 (day 21), 8 (day 28)

• N-back Test Proportion Correct Across 4 Load Factors

  Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)

Study Arms (2)

Vyvanse and transdermal nicotine patch

EXPERIMENTAL

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: Transdermal Nicotine Patch; Drug: Lis-dexamphetamine (Vyvanse)

Placebo and transdermal nicotine patch

PLACEBO COMPARATOR

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

Drug: Transdermal Nicotine Patch; Drug: Placebo

Interventions

Transdermal Nicotine Patch 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.

Also known as: Nicotine Patch

Placebo and transdermal nicotine patch; Vyvanse and transdermal nicotine patch

Lis-dexamphetamine (Vyvanse) 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.

Also known as: LDX and Transdermal Nicotine Patch

Vyvanse and transdermal nicotine patch

Placebo DRUG

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

Also known as: Placebo and Transdermal Nicotine Patch

Placebo and transdermal nicotine patch

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• other psychiatric conditions that require medication
• history of cardiovascular disease, clinically significant hypertension
• Body Mass index (BMI) \> 35

Sponsors & Collaborators

• Duke University: lead
• Shire: collaborator

Study Sites (1)

Duke Attention Deficit Hyperactivity Disorder (ADHD) Program

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Tobacco Use Disorder; Smoking

Interventions

Tobacco Use Cessation Devices; Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Limitations and Caveats

Limitations of the study: 1. Our sample size was quite small and this can realistically only be considered a pilot trial. 2.We did not collect systematic follow-up data on our sample after the end of treatment.3.the duration of our trial was short.

Results Point of Contact

• Title: Scott Kollins, PhD
• Organization: DukeUMC

kolli001@mc.duke.edu

9196810014

Study Officials

• Scott H Kollins, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 15, 2008
• Study Start: December 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 30, 2018
• Results First Posted: September 7, 2012

Record last verified: 2018-11

Locations

US (1)