Quit Nicotine: E-Cig Cessation Intervention

The purpose of this study is to find out if a new intervention helps teenagers who vape nicotine quit vaping. The program involves two parts: giving rewards (also called contingency management [CM]) and online video counseling (also called cognitive behavioral therapy [CBT]).

Study Overview

• Status: Recruiting
• Conditions: E-Cig Use
• Intervention / Treatment: Behavioral: Remote Contingency Management (CM) for nicotine abstinence; Other: Control

Detailed Description

Eligible participants will participate in a 4-week long Remote Contingency Management (Remote CM) intervention that involves the delivery of CM procedures using tablets, weekly vaping cessation CBT sessions, and follow-up appointments at 1, 3, 6, and 12 months.

Aim 1. To examine the feasibility, acceptability, and efficacy of web-based, remote Contingency Management (CM) for nicotine abstinence plus individualized Cognitive Behavioral Therapy (CBT) among youth e-cigarette (e-cig) users. High school students 13-19 years old who are regular e-cig users who want to quit (N=100) will be randomized to the Active group (CM for nicotine abstinence; reinforcement for negative saliva nicotine/cotinine; n=50) or Control group (reinforcement for providing saliva nicotine; n=50) for 4 weeks. Both groups will receive weekly CBT during this time (2 sessions prior to quitting, 4 weekly sessions after quitting). The investigators expect the Active group to have better treatment outcomes (7-day point prevalence abstinence at end-of-treatment [EOT] and follow ups [1, 3, 6, and 12- months]) than the Control group.

Aim 2. To examine the relationship between e-cig use characteristics, dependence, e-cig withdrawal, and treatment outcome/abstinence. It is anticipated that using higher nicotine concentrations; using a greater total number of flavors; vaping frequently or endorsing habitual use; and reporting fewer prior quit attempts will be associated with experiencing more severe dependence and e-cig withdrawal. In turn, researchers expect that experiencing more severe e-cig dependence before quitting and/or more severe withdrawal following the quit date will predict treatment failure (e.g., failure to achieve abstinence, a longer duration until abstinence is achieved, higher cotinine levels)

Aim 3. To test for changes in neurocognitive functioning in adolescent e-cig users across treatment for e- cig cessation. In this study, the Adolescent Brain and Cognitive Development study neurocognitive battery will be utilized. This will be administered at baseline and end of treatment to all participants (N=100). It is anticipated that youth e-cig users will show improvements in neurocognitive task performance (e.g., working memory, attention) from baseline to end of treatment. It is also predicted that improvements in neurocognitive task performance will be related to abstinence from e-cigs during treatment

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suchitra Krishnan-Sarin, PhD; Phone Number: (203) 974-7595; Email: suchitra.krishnan-sarin@yale.edu
• Study Contact Backup: Name: Thomas Liss, BS; Phone Number: (203) 974-7555; Email: thomas.liss@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale University
      • Contact: Thomas Liss; Phone Number: 203-974-7555; Email: thomas.liss@yale.edu
      • Contact: Heather LaVallee; Phone Number: 203-974-7373; Email: heather.sarnataro@yale.edu
      • Principal Investigator: Suchitra Krishnan-Sarin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• High school students between ages 13-20 years (plus 5 high school aged pilot participants)
• Able to read and write
• Regular e-cig users using nicotine (primary e-cig users with or without other tobacco use who report using e-cigs at least 4 days/week and have urine cotinine levels ≥200 ng/ml as determined by 1 Panel Quickscreen Cotinine/Nicotine Test Dipcard, COT200; Countrywide Testing) who want to quit. A repeat urine may be tested with the 200ng/ml dip test if subject reports levels of vaping that may be consistent with higher levels of cotinine.
• Does not meeting criteria for dependence on other psychoactive substances, psychosis, major depression or panic disorder based on psychological evaluation.

Exclusion Criteria:

• Currently enrolled in, or planning to enroll in any other behavioral or pharmacological treatments for cessation of nicotine or vaping.
• Current criteria for Substance Use Dependence (SUD) on other psychoactive substances. Endorsement of mild Cannabis Use Disorder will be allowed, due to the fact than many nicotine users may also be vaping cannabis
• Current diagnosis of psychosis or evidence of significant homicidal/suicidal risk.
• Current diagnosis of a significant mental health disorder that is not being treated by a mental health practitioner with either behavioral and/or pharmacological interventions.
• Regular use of any psychoactive drugs including anxiolytics and antidepressants unless the adolescent has been taking the medication consistently for 2 months, the medication is currently being monitored by a physician, and the condition for which the medication is taken is considered to be stable.
• Females who report being pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Contingency Management (CM) for nicotine abstinence; Participants will be paid increasing amounts of payment for each negative saliva cotinine test.	Behavioral: Remote Contingency Management (CM) for nicotine abstinence; Participants will be paid increasing amounts of payment for each negative saliva cotinine test.
Placebo Comparator: Control; Participants will be paid for providing saliva nicotine test, regardless of whether the test is positive or negative.	Other: Control; Participants will be paid for providing saliva nicotine test, regardless of whether the test is positive or negative.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 7-day point prevalence abstinence	Self reported of no e-cig usage during the 7 days prior and confirmed negativity with cotinine levels of 30ng/mL (Alere iScreen OFD Cotinine Saliva Test; Countrywide Testing).	End of treatment at week 4, 1, 3, 6, and 12 month

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Suchitra Krishnan-Sarin, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Contingency management
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2000028718; 20YVNR35460041 (Other Identifier: American Heart Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No