Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents (Pilot)

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.

Study Overview

• Status: Terminated
• Conditions: Nicotine Dependence; Vaping
• Intervention / Treatment: Drug: Varenicline; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Center for Addiction Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Varenicline; 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; Other Names: Chantix
Placebo Comparator: 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	Drug: Placebo; 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
No Intervention: Monitoring only; Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Treatment (Week 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.	Weeks 9-12
Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Follow-up (Week 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.	Weeks 9-24
Percentage of Change in Nicotine Product Exposure	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.	Baseline-week 24
Onset of Vaping Abstinence in 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.	Baseline-24 weeks
Latency to First Lapse in 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.	Baseline-24 weeks
Latency to Relapse in 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.	Baseline-24 weeks
Duration of Vaping Abstinence in 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.	Baseline-24 weeks
Total Number of Days of Vaping Abstinence	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.	Baseline-24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events During the Treatment Period	Adverse events are assessed via standardized questions prompting participants to report any changes in their physical or mental health.	Baseline-week 12
Nicotine Withdrawal Symptoms: Mean Difference (Week 16 - Baseline)	Symptoms will be assessed using the Minnesota Withdrawal Scale (MNWS), a 9-item self-rated scale of nicotine withdrawal symptoms, with scores ranging from 0 - 36, where higher scores indicate a greater degree of withdrawal. The difference between baseline and Week 16 will be computed for each participant.	Baseline to Week 16
Intensity of Nicotine Craving: Mean Difference (Week 12 - Baseline)	A Visual Analogue Scale was used to measure intensity of nicotine craving. The scale ranged from 0 (no desire at all) to 7 (unable to resist). Higher scores represent more intense nicotine craving.	Baseline to week 12
Severity of Nicotine Craving: Mean Difference (Week 12 - Baseline)	Severity of nicotine cravings will be assessed using the Questionnaire of Vaping Craving (QVC), a 10-item measure of vaping craving, with scores ranging from 10 - 70, where higher scores indicate greater craving for vaping products. The difference between baseline and Week 12 will be computed for each participant.	Baseline to Week12
Severity of Clinical Symptoms (Mood and Anxiety): Mean Difference (Week 16 - Baseline)	Severity of clinical symptoms will be assessed by the Mood and Anxiety Symptoms Questionnaire (MASQ-D30), a 30-item measure ranging from 30 - 150, with higher scores indicating a greater degree of clinical distress. The difference between baseline and Week 16 will be computed for each participant.	Baseline-week 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Substances Other Than Nicotine Consumed	Assessed with timeline follow back where individuals report the number of days, times, and amount of alcohol, tobacco, marijuana, and non-medical prescription drugs consumed since last study visit.	Baseline-week 16

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Eden Evins, MD, Massachusetts General Hospital; Principal Investigator: Randi Schuster, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Actual): June 27, 2022
• Study Completion (Actual): June 27, 2022

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Nicotine; Varenicline; Cessation; Vaping
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 2020P002774-Pilot; R01DA052583 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), and the study protocol, statistical analysis plan, analytic code, and informed consent form will be made available to researchers who provide a methodologically sound proposal beginning 3 months and ending 5 years following article publication to achieve aims in the approved proposal. Proposals should be directed to rschuster@mgh.harvard.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Data access agreement required.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes