Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study
|Attention Deficit Hyperactivity Disorder Nicotine Dependence||Drug: Lis-dexamphetamine (LDX; Vyvanse) and Transdermal Nicotine Patch Drug: Placebo and transdermal nicotine patch|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]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 [ Time Frame: Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8 ]Smoking rates, measured as self-reported cigarettes/day.
- Continuous Performance Test (CPT) Commission Errors [ Time Frame: Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8 ]The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors - measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.
- Continuous Performance Test (CPT) Reaction Time Standard Error [ Time Frame: Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8 ]The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors - measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.
- ADHD CAARS Self-Report and Observer Short Forms [ Time Frame: Randomization, visit 2, 4, 6, 8 ]T-scores derived from compiled ADHD symptoms from two forms.
- Cognitive Functioning [ Time Frame: Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8 ]This is measured by Continuous Performance Test (CPT) and N-Back
- Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I) [ Time Frame: Visits 2, 4, 6, & 8 ]Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment.
|Study Start Date:||December 2007|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
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.
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.
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736255
|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|