Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents

NCT04602494 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: 2020P002774-PilotR01DA052583
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaping; Nicotine Dependence

Keywords

Vaping; Nicotine; Adolescents; Cessation; Varenicline

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

• 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

Other Outcomes (1)

• Amount of Substances Other Than Nicotine Consumed

  Baseline-week 16

Study Arms (3)

Varenicline

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Monitoring only

NO INTERVENTION

Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.

Interventions

Varenicline DRUG

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

Also known as: Chantix

Varenicline

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for Addiction Medicine

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Vaping; Tobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Smoking; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: A. Eden Evins, MD, MPH
• Organization: Massachusetts General Hospital

aeevins@mgh.harvard.edu

6176434679

Study Officials

• Eden Evins, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Randi Schuster, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: December 18, 2020
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Data access agreement required.

Locations

US (1)