Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Duration of Vaping Abstinence in Weeks
研究概览
简要总结
The Investigators propose a randomized, placebo-controlled trial to test the hypothesis that varenicline added to group behavioral and texting support will be well tolerated and improve vaping cessation rates among nicotine dependent adolescents who vape, do not smoke regularly, and are willing to try treatment to stop vaping compared to placebo added to group behavioral and texting support. The study will consist of a three-arm randomized, placebo-controlled, parallel-group study of (1) varenicline up to 1 mg bid for 12 weeks added to behavioral and texting support compared with (2) behavioral and texting support and placebo and (3) monitoring only. The primary comparison will be of vaping cessation rates in those assigned to varenicline vs placebo.To do this, the investigators propose to enroll 300 adolescents aged 16-25 who meet eligibility criteria.
详细描述
Enrollees will include 300 nicotine dependent adolescents aged 16-25, who vape, do not smoke, and want to quit vaping. The study will will consist of a three-arm randomized, placebo-controlled, parallel-group study of (1) varenicline up to 1 mg bid for 12 weeks added to behavioral and texting support for adolescent vaping cessation or (2) behavioral and texting support and placebo or (3) monitoring only. The primary comparison of interest is efficacy of (1) varenicline vs (2) placebo arms on vaping abstinence outcomes. The study consists of one enrollment visit, one baseline visit, twelve weekly individual treatment and assessment sessions, and six monthly visits at weeks 4, 8, 12, 16, 20 and 24 weeks. At the enrollment visit, participants will complete interviews, questionnaires and diagnostic assessments, as well as saliva and urine sample and vitals. At the baseline visit, participants will complete several interviews, questionnaires, provide a saliva sample for cotinine measurement, and be randomized to the varenicline plus behavioral treatment group, the placebo plus behavioral treatment group, or monitoring-only group. Study staff will distribute varenicline or identically appearing placebo with instructions on how to take the study medication at weeks 0, 2, 4 and 8. Participants will be instructed to bring all empty and unused study medication at each in-person study visit through Week 12. At the weekly treatment meetings, participants will participate in cognitive behavioral therapy and complete questionnaires. Monthly visits will consist of interviews, questionnaires and a saliva and urine sample.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Eligible participants will be randomly assigned in a 1:1:1 ratio, in blocks of 6, to double-blind varenicline, identical placebo prepared by the MGH research pharmacy or monitoring (i.e., assessment only). Randomization will be computer generated by the MGH Research Pharmacy personnel with no other interactions with study staff or participants. The full randomization code (drug, placebo, monitoring) will be held in the MGH research pharmacy and available to study PI only in the case of urgent medical need. A partial randomization code (treatment vs monitoring) will be held by the interventionist at the Center for Addiction Medicine. Participants, investigators and outcome assessor will remain fully blind to all 3 arms.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-25 inclusive;
- •Self report of daily or near daily nicotine vaping for the prior ≥ 3 months, screening semi-quantitative urine cotinine positive for recent nicotine use, exhaled CO <10 ppm and score ≥4 on the 10-item E-cigarette Dependence Inventory (ECDI);
- •Self-report of no combusted tobacco use in the past 2 months at enrollment;
- •Total body weight at screening ≥35 kg (77 lbs) and Body Mass Index (BMI) ≤35 kg/m2;
- •Report motivation to quit vaping in the next 30 days;
- •Able to understand study procedures and read and write in English;
- •Competent and willing to consent to participate in study procedures.
排除标准
- •Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion);
- •Unwillingness to abstain during the study from using smoking cessation aids other than those provided by the study;
- •Unstable medical condition, epilepsy, severe renal impairment;
- •Evidence of active problem substance use severe enough in the investigator's opinion to compromise ability to safely participate;
- •Prior adverse drug reaction to varenicline;
- •Unwilling to provide urine samples;
- •Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol.
研究组 & 干预措施
Varenicline
Participants will receive varenicline 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks added to 12 weeks of group behavioral and texting support specifically designed for teen vaping cessation
干预措施: Varenicline (Drug)
Placebo
Participants will receive identical placebo 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks added to 12 weeks of group behavioral and texting support specifically designed for teen vaping cessation
干预措施: Placebo (Drug)
结局指标
主要结局
Duration of Vaping Abstinence in Weeks
时间窗: Baseline-24 weeks
Those assigned to varenicline will have a longer duration of abstinence in weeks. This measure was assessed by self-report and verified by urine cotinine testing at each study visit.
Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Treatment (Week 12)
时间窗: Weeks 9-12
Those assigned to varenicline and group behavioral and texting support will have a higher rate of cotinine verified, continuous nicotine vaping abstinence from study week 9 to end of treatment as operationalized by self-report of no nicotine vaping since the last study visit on a timeline followback assessment and urinary cotinine \<50 ng/mL at each study visit in the designated timeframe.
Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Follow-up (Week 24)
时间窗: Weeks 9-24
Those assigned to varenicline and group behavioral and texting support will have a higher rate of cotinine verified, continuous nicotine vaping abstinence from study week 9 to end of follow-up as operationalized by self-report of no nicotine vaping since the last study visit on a timeline followback assessment and urinary cotinine \<50 ng/ml at each study visit in the designated timeframe.
Percentage of Change in Nicotine Product Exposure
时间窗: Baseline-week 24
Those assigned to varenicline will have greater percentage reduction in vaped nicotine product exposure than those assigned to placebo as determined by urine cotinine from baseline to week 24. Cotinine is a byproduct of nicotine that is used to measure exposure to nicotine product exposure. Positive values represent increases and negative values represent decreases.
Onset of Vaping Abstinence in Weeks
时间窗: Baseline-24 weeks
Those assigned to varenicline will have earlier onset of abstinence. Onset of vaping abstinence (weeks) was assessed by participant self-report of vaping abstinence, and verified by urine cotinine testing.
Latency to First Lapse in Weeks
时间窗: Baseline-24 weeks
Those assigned to varenicline will have longer latency to first lapse. This outcome was assessed via self-report and verified by urine cotinine testing.
Latency to Relapse in Weeks
时间窗: Baseline-24 weeks
Those assigned to varenicline will have longer latency to relapse. This outcome was assessed by self-report and verified by urine cotinine testing at each study visit.
Total Number of Days of Vaping Abstinence
时间窗: Baseline-24 weeks
Those assigned to varenicline will have greater total number of days of vaping abstinence. Total number of days of vaping abstinence was assessed by self-report and verified by urine cotinine testing at each study visit.
次要结局
- Number of Adverse Events During the Treatment Period(Baseline-week 12)
- Nicotine Withdrawal Symptoms: Mean Difference (Week 16 - Baseline)(Baseline to Week 16)
- Intensity of Nicotine Craving: Mean Difference (Week 12 - Baseline)(Baseline to week 12)
- Severity of Nicotine Craving: Mean Difference (Week 12 - Baseline)(Baseline to Week12)
- Severity of Clinical Symptoms (Mood and Anxiety): Mean Difference (Week 16 - Baseline)(Baseline-week 16)
研究者
A. Eden Evins
Founder Director, Center for Addiction Medicine and Director for Faculty Development, Department of Psychiatry; Cox Family Professor of Psychiatry in the Field of Addiction Medicine
Massachusetts General Hospital