Lis-dexamphetamine (LDX/SPD489)as a Treatment for Smoking Cessation in Nicotine Dependent Individuals With ADHD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •other psychiatric conditions that require medication
- •history of cardiovascular disease, clinically significant hypertension
- •Body Mass index (BMI) > 35
研究组 & 干预措施
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.
干预措施: Transdermal Nicotine Patch (Drug)
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.
干预措施: Lis-dexamphetamine (Vyvanse) (Drug)
Placebo and transdermal nicotine patch
The second group will receive matching placebo and NRT after the quit date.
干预措施: Transdermal Nicotine Patch (Drug)
Placebo and transdermal nicotine patch
The second group will receive matching placebo and NRT after the quit date.
干预措施: Placebo (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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) 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))
- 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))
- 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))
- Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I)(Visits 2 (day 7), 4 (day 14), 6 (day 21), 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))