NCT04898075

Brief 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 \[CBT\]).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

3.8 years

First QC Date

May 18, 2021

Last Update Submit

March 7, 2025

Conditions

E-Cig Use

Keywords

Contingency management

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Remote Contingency Management (CM) for nicotine abstinence

EXPERIMENTAL

Participants will be paid increasing amounts of payment for each negative saliva cotinine test.

Behavioral: Remote Contingency Management (CM) for nicotine abstinence

Control

PLACEBO COMPARATOR

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

Other: Control

Interventions

Remote Contingency Management (CM) for nicotine abstinenceBEHAVIORAL

Participants will be paid increasing amounts of payment for each negative saliva cotinine test.

Remote Contingency Management (CM) for nicotine abstinence
ControlOTHER

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

Control

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior

Study Officials

  • Suchitra Krishnan-Sarin, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 24, 2021

Study Start

April 1, 2021

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)