Randomized Controlled Trial of Varenicline for Cessation of Nicotine Vaping in Adolescent Non-smokers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 1
- 主要终点
- Continuous 4-week Nicotine Vaping Abstinence at End of Treatment (Weeks 9-12)
研究概览
简要总结
The study will test the hypothesis that varenicline, when added to behavioral and texting support for vaping cessation, will improve vaping abstinence rates in adolescents dependent on vaped nicotine over placebo plus behavioral and texting support for vaping cessation. Approximately 225 adolescents will be randomly assigned to one of three arms (1) varenicline up to 1 mg bid for 12 weeks plus behavioral and texting support for vaping cessation (V+BC), (2) identical appearing placebo plus behavioral and texting support (P+BC) and (3) enhanced usual care (EUC). The primary comparison will be the double-blind, placebo-controlled comparison of vaping cessation rates in those assigned to varenicline vs placebo.
详细描述
Up to 300 adolescents, aged 16-25, who vape, do not smoke regularly, and want to quit vaping will be consented; approximately 225 eligible participants will be randomly assigned to a double blind, placebo-controlled intervention consisting of (1) varenicline or (2) identical placebo, up to 1 mg bid for 12 weeks, plus behavioral and texting support for adolescent vaping cessation or to (3) enhanced usual care. The primary comparison of interest is the double blind, placebo-controlled efficacy comparison of those assigned to (1) varenicline vs (2) placebo on vaping abstinence outcomes. The secondary comparison of placebo plus behavioral and texting support vs. EUC will estimate the efficacy of behavioral and texting support for vaping cessation in this population. The secondary comparison of varenicline plus behavioral and texting support vs EUC will estimate of the efficacy of varenicline treatment plus behavioral and texting support for vaping cessation in this population vs no treatment, the most common vaping cessation intervention. All participants will complete enrollment and baseline visits, and six monthly assessment visits. Those assigned to double blind intervention (study arms 1 or 2) will also complete 12 weekly behavioral support sessions. Assessors will be blind to intervention assignment (arm 1 or 2) vs EUC (arm 3) assignment. Among those assigned to the V+BC or P+BC intervention arms, study staff and participants will be blind to active varenicline vs placebo assignment, such that among those assigned to intervention (arm 1 or 2), assignment to study drug will be double blind. For those assigned a double blind intervention arm, study staff will distribute varenicline or identical appearing placebo and give instructions use at weeks 0, 2, 4 and 8. Participants will be asked to bring all empty and unused study medication at each in-person study visit through Week 12. The enrollment visit will consist of questionnaires, diagnostic assessments, vitals, saliva and urine samples. The baseline visit will consist of questionnaires, a saliva sample for cotinine concentration, and randomization. Monthly visits will consist of interviews, questionnaires and a saliva and urine sample. Weekly treatment meetings for participants assigned to arms 1 or 2 will consist of cognitive behavioral support and questionnaires.
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 assigned to one of three groups using a computer-generated randomization code conducted by MGH Research Pharmacy personnel with no other interactions with participants.
The full randomization code of the two double blind treatment arms (arm 1 active varenicline and arm 2 identical placebo), and the single blind EUC arm (arm 3) will be held in the MGH research pharmacy and available to study PIs for urgent medical need only. Participants, investigators and outcome assessors will be fully blind to all 3 arms.
A partial randomization code identifying those assigned to double-blind treatment (a combined list of study IDs assigned to either study arm 1 or 2) vs single blind EUC (study arm 3) will be held by a scheduler who is not associated with outcomes assessment, data analysis or interpretation. Assignment to Arm 3, single blind EUC only, will be masked to investigators and outcomes assessors.
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 16-25, inclusive;
- •Self-report of daily or near daily nicotine vaping for the prior ≥ 3 months and semi-quantitative saliva screening for cotinine positive for recent nicotine use;
- •Nicotine dependence as defined by a score ≥4 on the 10-item E-cigarette Dependence Inventory (ECDI), or report of persistent use despite negative consequences, or prior failed quit attempts;
- •Self-report of no regular combusted tobacco use in the past 2 months at enrollment and exhaled CO <10 ppm;
- •Total body weight at enrollment ≥35 kg (77 lbs);
- •Report willingness to try varenicline to stop vaping;
- •Able to understand study procedures and read and write in English;
- •Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18);
- •Competent and willing to provide written informed consent (if age 18+) or assent (if under 18);
- •For participants who could become pregnant: negative urine pregnancy test at enrollment and agree to use effective contraception (e.g., abstinence, hormonal contraception, intra-uterine device, sterilization, or double barrier contraception) during the study.
排除标准
- •Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion);
- •Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study;
- •Unstable medical condition, epilepsy, severe renal impairment;
- •Inpatient psychiatric hospitalization in the prior 6 months, serious suicidal ideation or suicide attempt within 6 months of enrollment, recent active suicidal ideation or suicidal behavior identified at enrollment or baseline visits;
- •Evidence of active problem substance use severe enough to compromise ability to safely participate, in the investigator's opinion;
- •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;
- •Ward of the state.
研究组 & 干预措施
Double Blind Varenicline (V + BC)
Participants will...
- Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks.
- Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks.
- Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
干预措施: Double Blind Varenicline (Drug)
Double Blind Varenicline (V + BC)
Participants will...
- Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks.
- Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks.
- Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
干预措施: QuitVaping (Behavioral)
Double Blind Varenicline (V + BC)
Participants will...
- Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks.
- Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks.
- Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
干预措施: This Is Quitting (Behavioral)
Double Blind Placebo (P + BC)
Participants will...
- Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks.
- Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks.
- Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
干预措施: Double Blind Placebo (Drug)
Double Blind Placebo (P + BC)
Participants will...
- Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks.
- Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks.
- Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
干预措施: QuitVaping (Behavioral)
Double Blind Placebo (P + BC)
Participants will...
- Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks.
- Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks.
- Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
干预措施: This Is Quitting (Behavioral)
Single Blind Enhanced Usual Care (EUC)
Participants will...
- Receive NO drug intervention.
- Attend NO behavioral support sessions.
- Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
干预措施: This Is Quitting (Behavioral)
结局指标
主要结局
Continuous 4-week Nicotine Vaping Abstinence at End of Treatment (Weeks 9-12)
时间窗: Assessments at study weeks 9, 10, 11, and 12
Point-prevalence abstinence from e-cigarette use was defined as self-report of no e-cigarette use since the last visit, bioverified by saliva cotinine \<30 ng/ml. Continuous abstinence is defined as observed point-prevalence abstinence over specified study visits at weeks 9, 10, 11 and 12. Visits with self-reported abstinence missing bioverification were treated as missing, with missingness addressed via multiple imputation.
次要结局
- Seven-Day Point-Prevalence Nicotine Vaping Abstinence at End of Treatment (Week 12)(Study week 12)
- Continuous Nicotine Vaping Abstinence Over Study Weeks 9 to 24(Study weeks 9, 10, 11, 12, 16, 20, 24)
- Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12)(Study weeks 1-12)
- Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12)(Study weeks 1-12)
- Mood and Anxiety Symptoms Questionnaire (MASQ-D30) General Distress Subscore (Weeks 4, 8, and 12)(Study weeks 4, 8, 12)
- Neuropsychiatric Adverse Event Inventory (NAEI) Elicited Adverse Events by Week 12(Study weeks 1-12)
研究者
Anne 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