Quit Nicotine: E-Cig Cessation Intervention

E-Cig Use Clinical Trial

Official title:

Quit Nicotine: E-Cig Cessation Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898075
• Other study ID #: 2000028718
• Secondary ID: 20YVNR35460041
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: January 5, 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Suchitra Krishnan-Sarin, PhD
• Phone: (203) 974-7595
• Email: suchitra.krishnan-sarin[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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]).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 5, 2025
• Est. primary completion date: January 5, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• E-Cig Use

Intervention

Behavioral:
• Remote Contingency Management (CM) for nicotine abstinence
Participants will be paid increasing amounts of payment for each negative saliva cotinine test.

Other:
• Control
Participants will be paid for providing saliva nicotine test, regardless of whether the test is positive or negative.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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