Clinical trial NCT04602494: Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents
Official title: Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Vaping
Nicotine Dependence
Keywords: Vaping
Nicotine
Adolescents
Cessation
Varenicline
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-10-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This a 3-arm, randomized, placebo-controlled, parallel-group design of (1) varenicline up to 1 mg bid for 12 weeks added to behavioral and texting support vaping cessation compared or (2) behavioral and texting support and placebo or (3) monitoring only.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Treatment (Week 12)
timeFrame: Weeks 9-12
measure: Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Follow-up (Week 24)
timeFrame: Weeks 9-24
measure: Percentage of Change in Nicotine Product Exposure
timeFrame: Baseline-week 24
measure: Onset of Vaping Abstinence in Weeks
timeFrame: Baseline-24 weeks
measure: Latency to First Lapse in Weeks
timeFrame: Baseline-24 weeks
measure: Latency to Relapse in Weeks
timeFrame: Baseline-24 weeks
measure: Duration of Vaping Abstinence in Weeks
timeFrame: Baseline-24 weeks
measure: Total Number of Days of Vaping Abstinence
timeFrame: Baseline-24 weeks
Secondary outcomes:
measure: Number of Adverse Events During the Treatment Period
timeFrame: Baseline-week 12
measure: Nicotine Withdrawal Symptoms: Mean Difference (Week 16 - Baseline)
timeFrame: Baseline to Week 16
measure: Intensity of Nicotine Craving: Mean Difference (Week 12 - Baseline)
timeFrame: Baseline to week 12
measure: Severity of Nicotine Craving: Mean Difference (Week 12 - Baseline)
timeFrame: Baseline to Week12
measure: Severity of Clinical Symptoms (Mood and Anxiety): Mean Difference (Week 16 - Baseline)
timeFrame: Baseline-week 16
Other outcomes:
measure: Amount of Substances Other Than Nicotine Consumed
timeFrame: Baseline-week 16
Locations:
city: Boston
country: United States
facility: Center for Addiction Medicine
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Eden Evins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Randi Schuster, PhD
role: PRINCIPAL_INVESTIGATOR
References: