E-Cig UseNCT04898075
Quit Nicotine: E-Cig Cessation Intervention
A study testing Remote Contingency Management (CM) for nicotine abstinence in people with E-Cig Use, run by Yale University at 1 site in United States.
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]). Read more about this study
- Who is it for?
- Ages 13 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- E-Cig Use
- What is being tested?
- Remote Contingency Management (CM) for nicotine abstinence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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]).
Read the 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
- Conditions
- E-Cig Use
- Being tested
- Remote Contingency Management (CM) for nicotine abstinence, Control
- Keywords
- Contingency management
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Contingency Management (CM) for nicotine abstinenceBehavioural
Participants will be paid increasing amounts of payment for each negative saliva cotinine test.
ControlOther
Participants will be paid for providing saliva nicotine test, regardless of whether the test is positive or negative.
| Study group | Role | What they receive |
|---|---|---|
| Remote Contingency Management (CM) for nicotine abstinence | Experimental | Participants will be paid increasing amounts of payment for each negative saliva cotinine test. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: End of treatment at week 4, 1, 3, 6, and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Apr 2021
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-Cig UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Suchitra Krishnan-Sarin, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898075
- Sponsor's protocol ID
- 2000028718
- Other IDs
- 20YVNR35460041
- Status last verified
- Mar 2025
- First submitted
- 18 May 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quit Nicotine: E-Cig Cessation Intervention
- ClinicalTrials.gov ID
- NCT04898075
- Acronym / sponsor ID
- 2000028718
- Conditions
- E-Cig Use
- Keywords
- Contingency management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Contingency Management (CM) for nicotine abstinence | Experimental | Behavioral: Remote Contingency Management (CM) for nicotine abstinenceParticipants will be paid increasing amounts of payment for each negative saliva cotinine test. |
| Control | Placebo comparator | Other: ControlParticipants will be paid for providing saliva nicotine test, regardless of whether the test is positive or negative. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Contingency Management (CM) for nicotine abstinenceParticipants will be paid increasing amounts of payment for each negative saliva cotinine test. | Behavioural | Remote Contingency Management (CM) for nicotine abstinence |
| ControlParticipants will be paid for providing saliva nicotine test, regardless of whether the test is positive or negative. | Other | Control |
Primary outcome
Change in 7-day point prevalence abstinence
Time frame: End of treatment at week 4, 1, 3, 6, and 12 month
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for E-Cig Use
Not yet recruiting
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Pilot Study of Communication for Dual Users of Cigarettes and E-cigarettes
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STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
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A Study to Determine the Effect of Access to Multiple Tobacco Flavor Options on Smoking Abstinence Among Primary Cigarette Smokers Using an Electronic Nicotine Delivery System
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E Cigarette Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suchitra Krishnan-Sarin, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Contingency Management (CM) for nicotine abstinence in people with E-Cig Use, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 7-day point prevalence abstinence (time frame: End of treatment at week 4, 1, 3, 6, and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.