Trial Outcomes & Findings for Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents (NCT NCT04602494)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

Weeks 9-12

Results posted on

2024-04-04

Participant Flow

Five participants signed consent and were enrolled. One (1) subject was considered a screen fail and not randomized to an arm/group, and four (4) subjects were randomized.

Participant milestones

Participant milestones
Measure	Varenicline 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 Varenicline: 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	Placebo 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 Placebo: 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	Monitoring Only Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Overall Study STARTED	1	1	2
Overall Study COMPLETED	1	1	0
Overall Study NOT COMPLETED	0	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varenicline n=1 Participants 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 Varenicline: 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	Placebo n=1 Participants 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 Placebo: 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	Monitoring Only n=2 Participants Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.	Total n=4 Participants Total of all reporting groups
Age, Continuous	21 years STANDARD_DEVIATION 0 • n=5 Participants	21 years STANDARD_DEVIATION 0 • n=7 Participants	21.5 years STANDARD_DEVIATION 0.50 • n=5 Participants	21.25 years STANDARD_DEVIATION 0.43 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Weeks 9-12

Population: 5 people enrolled in the pilot, 1 was a screen fail, 4 were enrolled and have been included in the analysis. Due to the small number of participants enrolled in the pilot, data is presented as participant count.

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.

Outcome measures

Outcome measures
Measure	Varenicline n=1 Participants 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 Varenicline: 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	Placebo n=1 Participants 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 Placebo: 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	Monitoring Only n=2 Participants Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Percentage of Participants With Continuous Nicotine Vaping Abstinence From Week 9 Through End of Treatment (Week 12)	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Weeks 9-24

Population: No participant reached 24 weeks in the study, and as such, were not included in the analysis.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline-week 24

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.

Outcome measures

Outcome measures
Measure	Varenicline n=1 Participants 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 Varenicline: 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	Placebo n=1 Participants 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 Placebo: 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	Monitoring Only n=2 Participants Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Percentage of Change in Nicotine Product Exposure	-99 percentage change in nicotine exposure	-100 percentage change in nicotine exposure	0 percentage change in nicotine exposure

PRIMARY outcome

Timeframe: Baseline-24 weeks

Population: No participants in the monitoring only group quit vaping.

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.

Outcome measures

Outcome measures
Measure	Varenicline n=1 Participants 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 Varenicline: 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	Placebo n=1 Participants 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 Placebo: 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	Monitoring Only Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Onset of Vaping Abstinence in Weeks	8 Weeks	2 Weeks	—

PRIMARY outcome

Timeframe: Baseline-24 weeks

Population: No participants in the monitoring only group quit vaping, and as such, could not lapse.

Those assigned to varenicline will have longer latency to first lapse. This outcome was assessed via self-report and verified by urine cotinine testing.

Outcome measures

Outcome measures
Measure	Varenicline n=1 Participants 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 Varenicline: 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	Placebo n=1 Participants 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 Placebo: 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	Monitoring Only Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Latency to First Lapse in Weeks	10 Weeks	NA Weeks Participant did not have a lapse from week 2 to the end of the trial.	—

PRIMARY outcome

Timeframe: Baseline-24 weeks

Population: No participants in the monitoring only group quit vaping, and as such, could not relapse.

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.

Outcome measures

Outcome measures
Measure	Varenicline n=1 Participants 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 Varenicline: 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	Placebo n=1 Participants 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 Placebo: 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	Monitoring Only Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Latency to Relapse in Weeks	NA Weeks Participant in the varenicline group quit vaping at week 8, had a lapse at week 10, and then stayed abstinent until the end of the trial. No relapse reported.	NA Weeks Participant in the placebo group quit vaping at week 2 and stayed abstinent until the end of the trial. No relapse reported.	—

PRIMARY outcome

Timeframe: Baseline-24 weeks

Population: No participants in the monitoring group quit vaping.

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.

Outcome measures

Outcome measures
Measure	Varenicline n=1 Participants 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 Varenicline: 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	Placebo n=1 Participants 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 Placebo: 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	Monitoring Only Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Duration of Vaping Abstinence in Weeks	15 Weeks	22 Weeks	—

PRIMARY outcome

Timeframe: Baseline-24 weeks

Population: No participant reached 24 weeks in the study, and as such, were not included in the analysis.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline-week 12

Population: Monitoring only participants didn't complete week 12, data includes AEs collected as of their last visit

Adverse events are assessed via standardized questions prompting participants to report any changes in their physical or mental health.

Outcome measures

Outcome measures
Measure	Varenicline n=1 Participants 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 Varenicline: 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	Placebo n=1 Participants 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 Placebo: 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	Monitoring Only n=2 Participants Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Number of Adverse Events During the Treatment Period	3 Number of adverse events Standard Deviation 0	4 Number of adverse events Standard Deviation 0	2.5 Number of adverse events Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Participants in the placebo and monitoring group didn't provide post baseline outcome measure data, and therefore were not included in the analysis.

Symptoms will be assessed using the Minnesota Withdrawal Scale (MNWS), a 9-item self-rated scale of nicotine withdrawal symptoms, with scores ranging from 0 - 36, where higher scores indicate a greater degree of withdrawal. The difference between baseline and Week 16 will be computed for each participant.

Outcome measures

Outcome measures
Measure	Varenicline n=1 Participants 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 Varenicline: 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	Placebo 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 Placebo: 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	Monitoring Only Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Nicotine Withdrawal Symptoms: Mean Difference (Week 16 - Baseline)	-7 score on a scale Standard Deviation 0	—	—

SECONDARY outcome

Timeframe: Baseline to week 12

Population: Measure data was not collected from any enrolled participant.

A Visual Analogue Scale was used to measure intensity of nicotine craving. The scale ranged from 0 (no desire at all) to 7 (unable to resist). Higher scores represent more intense nicotine craving.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Week12

Population: participants in the monitoring group didn't provide post baseline outcome measure therefore were not included in the analysis.

Severity of nicotine cravings will be assessed using the Questionnaire of Vaping Craving (QVC), a 10-item measure of vaping craving, with scores ranging from 10 - 70, where higher scores indicate greater craving for vaping products. The difference between baseline and Week 12 will be computed for each participant.

Outcome measures

Outcome measures
Measure	Varenicline n=1 Participants 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 Varenicline: 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	Placebo n=1 Participants 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 Placebo: 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	Monitoring Only Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Severity of Nicotine Craving: Mean Difference (Week 12 - Baseline)	-16 score on a scale Standard Deviation 0	-18 score on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: Baseline-week 16

Population: participants in the monitoring group didn't provide post baseline outcome measure therefore were not included in the analysis.

Severity of clinical symptoms will be assessed by the Mood and Anxiety Symptoms Questionnaire (MASQ-D30), a 30-item measure ranging from 30 - 150, with higher scores indicating a greater degree of clinical distress. The difference between baseline and Week 16 will be computed for each participant.

Outcome measures

Outcome measures
Measure	Varenicline n=1 Participants 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 Varenicline: 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	Placebo n=1 Participants 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 Placebo: 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	Monitoring Only Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Severity of Clinical Symptoms (Mood and Anxiety): Mean Difference (Week 16 - Baseline)	-11 score on a scale Standard Deviation 0	-12 score on a scale Standard Deviation 0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline-week 16

Assessed with timeline follow back where individuals report the number of days, times, and amount of alcohol, tobacco, marijuana, and non-medical prescription drugs consumed since last study visit.

Outcome measures

Outcome data not reported

Adverse Events

Varenicline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Monitoring Only

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Varenicline n=1 participants at risk 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 Varenicline: 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	Placebo n=1 participants at risk 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 Placebo: 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	Monitoring Only n=2 participants at risk Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Renal and urinary disorders Kidney Infection	0.00% 0/1 • Adverse event data was collected over 24 weeks.	0.00% 0/1 • Adverse event data was collected over 24 weeks.	100.0% 2/2 • Number of events 3 • Adverse event data was collected over 24 weeks.

Other adverse events

Other adverse events
Measure	Varenicline n=1 participants at risk 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 Varenicline: 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	Placebo n=1 participants at risk 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 Placebo: 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	Monitoring Only n=2 participants at risk Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Psychiatric disorders Increased Stress	0.00% 0/1 • Adverse event data was collected over 24 weeks.	0.00% 0/1 • Adverse event data was collected over 24 weeks.	50.0% 1/2 • Number of events 1 • Adverse event data was collected over 24 weeks.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/1 • Adverse event data was collected over 24 weeks.	0.00% 0/1 • Adverse event data was collected over 24 weeks.	50.0% 1/2 • Number of events 1 • Adverse event data was collected over 24 weeks.
Surgical and medical procedures Wisdom Teeth Removal	100.0% 1/1 • Number of events 1 • Adverse event data was collected over 24 weeks.	100.0% 1/1 • Number of events 1 • Adverse event data was collected over 24 weeks.	0.00% 0/2 • Adverse event data was collected over 24 weeks.
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 3 • Adverse event data was collected over 24 weeks.	100.0% 1/1 • Number of events 1 • Adverse event data was collected over 24 weeks.	0.00% 0/2 • Adverse event data was collected over 24 weeks.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/1 • Adverse event data was collected over 24 weeks.	100.0% 1/1 • Number of events 1 • Adverse event data was collected over 24 weeks.	0.00% 0/2 • Adverse event data was collected over 24 weeks.
Metabolism and nutrition disorders Appetite Excessive	0.00% 0/1 • Adverse event data was collected over 24 weeks.	100.0% 1/1 • Number of events 1 • Adverse event data was collected over 24 weeks.	0.00% 0/2 • Adverse event data was collected over 24 weeks.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/1 • Adverse event data was collected over 24 weeks.	100.0% 1/1 • Number of events 1 • Adverse event data was collected over 24 weeks.	0.00% 0/2 • Adverse event data was collected over 24 weeks.

Additional Information

A. Eden Evins, MD, MPH

Massachusetts General Hospital

Phone: 6176434679

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place