Trial Outcomes & Findings for Varenicline for Nicotine Vaping Cessation in Adolescents (NCT NCT05367492)

Last Updated: 2025-04-27

Results Overview

Point-prevalence abstinence from e-cigarette use was defined as self-report of no e-cigarette use since the last visit, bioverified by saliva cotinine \<30 ng/ml. Continuous abstinence is defined as observed point-prevalence abstinence over specified study visits at weeks 9, 10, 11 and 12. Visits with self-reported abstinence missing bioverification were treated as missing, with missingness addressed via multiple imputation.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

261 participants

Primary outcome timeframe

Assessments at study weeks 9, 10, 11, and 12

Results posted on

2025-04-27

Participant Flow

This trial recruited participants from a single U.S. state from June 2022 to November 2023.

Participant milestones

Participant milestones
Measure	Double Blind Varenicline (V+BC) Participants will... * Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Double Blind Placebo (P+BC) Participants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Single Blind Enhanced Usual Care (EUC) Participants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents
Study Intervention (Week 12) STARTED	88	87	86
Study Intervention (Week 12) COMPLETED	88	83	85
Study Intervention (Week 12) NOT COMPLETED	0	4	1
Study Follow Up (Week 24) STARTED	88	83	85
Study Follow Up (Week 24) COMPLETED	88	81	85
Study Follow Up (Week 24) NOT COMPLETED	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Double Blind Placebo (P+BC) Participants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Single Blind Enhanced Usual Care (EUC) Participants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents
Study Intervention (Week 12) Withdrawal by Subject	2	0
Study Intervention (Week 12) Lost to Follow-up	2	1
Study Follow Up (Week 24) Withdrawal by Subject	1	0
Study Follow Up (Week 24) Lost to Follow-up	1	0

Baseline Characteristics

Due to technical issues with the timeline followback application, data was lost for 7 participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double Blind Varenicline (V+BC) n=88 Participants Participants will... * Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Double Blind Placebo (P+BC) n=87 Participants Participants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Single Blind Enhanced Usual Care (EUC) n=86 Participants Participants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Total n=261 Participants Total of all reporting groups
Age, Continuous	21.6 years STANDARD_DEVIATION 2.0 • n=88 Participants	21.4 years STANDARD_DEVIATION 2.1 • n=87 Participants	21.4 years STANDARD_DEVIATION 2.0 • n=86 Participants	21.5 years STANDARD_DEVIATION 2.0 • n=261 Participants
Sex: Female, Male Female	46 Participants n=88 Participants	47 Participants n=87 Participants	46 Participants n=86 Participants	139 Participants n=261 Participants
Sex: Female, Male Male	42 Participants n=88 Participants	40 Participants n=87 Participants	40 Participants n=86 Participants	122 Participants n=261 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=88 Participants	18 Participants n=87 Participants	8 Participants n=86 Participants	43 Participants n=261 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=88 Participants	69 Participants n=87 Participants	78 Participants n=86 Participants	218 Participants n=261 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=88 Participants	0 Participants n=87 Participants	0 Participants n=86 Participants	0 Participants n=261 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=88 Participants	1 Participants n=87 Participants	0 Participants n=86 Participants	1 Participants n=261 Participants
Race (NIH/OMB) Asian	13 Participants n=88 Participants	17 Participants n=87 Participants	18 Participants n=86 Participants	48 Participants n=261 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=88 Participants	0 Participants n=87 Participants	0 Participants n=86 Participants	0 Participants n=261 Participants
Race (NIH/OMB) Black or African American	5 Participants n=88 Participants	7 Participants n=87 Participants	4 Participants n=86 Participants	16 Participants n=261 Participants
Race (NIH/OMB) White	56 Participants n=88 Participants	49 Participants n=87 Participants	55 Participants n=86 Participants	160 Participants n=261 Participants
Race (NIH/OMB) More than one race	10 Participants n=88 Participants	10 Participants n=87 Participants	8 Participants n=86 Participants	28 Participants n=261 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=88 Participants	3 Participants n=87 Participants	1 Participants n=86 Participants	8 Participants n=261 Participants
Region of Enrollment United States	88 participants n=88 Participants	87 participants n=87 Participants	86 participants n=86 Participants	261 participants n=261 Participants
Post-secondary School	86 Participants n=88 Participants	85 Participants n=87 Participants	86 Participants n=86 Participants	257 Participants n=261 Participants
E-cigarette use: Median number of days used per week in last 30 days	7 days per week n=87 Participants • Due to technical issues with the timeline followback application, data was lost for 7 participants.	7 days per week n=84 Participants • Due to technical issues with the timeline followback application, data was lost for 7 participants.	7 days per week n=83 Participants • Due to technical issues with the timeline followback application, data was lost for 7 participants.	7 days per week n=254 Participants • Due to technical issues with the timeline followback application, data was lost for 7 participants.
E-Cigarette Dependence Inventory (ECDI)	12.5 total score on a scale STANDARD_DEVIATION 3.8 • n=88 Participants	13.7 total score on a scale STANDARD_DEVIATION 4.0 • n=87 Participants	12.8 total score on a scale STANDARD_DEVIATION 3.8 • n=86 Participants	13.0 total score on a scale STANDARD_DEVIATION 3.9 • n=261 Participants
Motivation to Quit Vaping	7.1 score on a scale STANDARD_DEVIATION 1.7 • n=88 Participants	6.7 score on a scale STANDARD_DEVIATION 1.8 • n=87 Participants	7.1 score on a scale STANDARD_DEVIATION 1.6 • n=86 Participants	7.0 score on a scale STANDARD_DEVIATION 1.7 • n=261 Participants
Minnesota Nicotine Withdrawal Scale (MNWS)	10.5 score on a scale STANDARD_DEVIATION 6.1 • n=88 Participants	10.6 score on a scale STANDARD_DEVIATION 6.1 • n=87 Participants	11.2 score on a scale STANDARD_DEVIATION 6.0 • n=86 Participants	10.8 score on a scale STANDARD_DEVIATION 6.0 • n=261 Participants
Questionnaire of Vaping Craving (QVC)	41.3 score on a scale STANDARD_DEVIATION 11.5 • n=88 Participants	42.3 score on a scale STANDARD_DEVIATION 13.1 • n=87 Participants	38.5 score on a scale STANDARD_DEVIATION 13.8 • n=86 Participants	40.7 score on a scale STANDARD_DEVIATION 12.9 • n=261 Participants
Combusted Tobacco: Past 30-day use	6 Participants n=86 Participants • Due to technical issues with the timeline followback application, data was lost for 5 participants.	7 Participants n=87 Participants • Due to technical issues with the timeline followback application, data was lost for 5 participants.	8 Participants n=83 Participants • Due to technical issues with the timeline followback application, data was lost for 5 participants.	21 Participants n=256 Participants • Due to technical issues with the timeline followback application, data was lost for 5 participants.
Combusted Tobacco: Median number of days used per week in last 30 days	0 days per week n=85 Participants • Due to technical issues with the timeline followback application, data was lost for 7 participants.	0 days per week n=86 Participants • Due to technical issues with the timeline followback application, data was lost for 7 participants.	0 days per week n=83 Participants • Due to technical issues with the timeline followback application, data was lost for 7 participants.	0 days per week n=254 Participants • Due to technical issues with the timeline followback application, data was lost for 7 participants.
Lifetime cigarettes smoked ≥100	9 Participants n=88 Participants	7 Participants n=87 Participants	5 Participants n=86 Participants	21 Participants n=261 Participants
Cannabis: Past 30-day use	61 Participants n=86 Participants • Due to technical issues with the timeline followback application, data was lost for 5 participants.	64 Participants n=87 Participants • Due to technical issues with the timeline followback application, data was lost for 5 participants.	62 Participants n=83 Participants • Due to technical issues with the timeline followback application, data was lost for 5 participants.	187 Participants n=256 Participants • Due to technical issues with the timeline followback application, data was lost for 5 participants.
Cannabis: Median number of days used per week in last 30 days	0.9 days per week n=85 Participants • Due to technical issues with the timeline followback application, data was lost for 7 participants.	2.1 days per week n=86 Participants • Due to technical issues with the timeline followback application, data was lost for 7 participants.	1.2 days per week n=83 Participants • Due to technical issues with the timeline followback application, data was lost for 7 participants.	1.4 days per week n=254 Participants • Due to technical issues with the timeline followback application, data was lost for 7 participants.
Cannabis Use Disorders Identification Test- Revised (CUDIT-R)	6 score on a scale n=87 Participants • A total score could not be calculated for two participants due to missing items.	8 score on a scale n=87 Participants • A total score could not be calculated for two participants due to missing items.	8 score on a scale n=85 Participants • A total score could not be calculated for two participants due to missing items.	7 score on a scale n=259 Participants • A total score could not be calculated for two participants due to missing items.
Alcohol: Past 30-day use	87 Participants n=88 Participants	79 Participants n=87 Participants	82 Participants n=86 Participants	248 Participants n=261 Participants
Alcohol: Median number of days used per week in last 30 days	1.4 days per week n=83 Participants • Due to technical issues with the timeline followback application, data was lost for 12 participants.	1.2 days per week n=85 Participants • Due to technical issues with the timeline followback application, data was lost for 12 participants.	0.9 days per week n=81 Participants • Due to technical issues with the timeline followback application, data was lost for 12 participants.	1.2 days per week n=249 Participants • Due to technical issues with the timeline followback application, data was lost for 12 participants.
Alcohol Use Disorders Identification Test (AUDIT)	5 score on a scale n=86 Participants • A total score could not be calculated for 4 participants due to missing items.	7 score on a scale n=86 Participants • A total score could not be calculated for 4 participants due to missing items.	6 score on a scale n=85 Participants • A total score could not be calculated for 4 participants due to missing items.	6 score on a scale n=257 Participants • A total score could not be calculated for 4 participants due to missing items.
Any self-reported psychiatric diagnosis	60 Participants n=88 Participants	61 Participants n=87 Participants	55 Participants n=86 Participants	176 Participants n=261 Participants
Current Psychotropic Medication Use	33 Participants n=88 Participants	33 Participants n=87 Participants	33 Participants n=86 Participants	99 Participants n=261 Participants
Mood and Anxiety Symptoms Questionnaire (MASQ-D30) Total Score	57.8 score on a scale STANDARD_DEVIATION 14.5 • n=88 Participants	58.3 score on a scale STANDARD_DEVIATION 14.8 • n=87 Participants	58.6 score on a scale STANDARD_DEVIATION 15.3 • n=86 Participants	58.2 score on a scale STANDARD_DEVIATION 14.8 • n=261 Participants
Mood and Anxiety Symptoms Questionnaire (MASQ-D30): General Distress Score	17.4 score on a scale STANDARD_DEVIATION 6.7 • n=88 Participants	17.5 score on a scale STANDARD_DEVIATION 6.0 • n=87 Participants	18.8 score on a scale STANDARD_DEVIATION 7.9 • n=86 Participants	17.9 score on a scale STANDARD_DEVIATION 6.9 • n=261 Participants

PRIMARY outcome

Timeframe: Assessments at study weeks 9, 10, 11, and 12

Outcome measures

Outcome measures
Measure	Double Blind Varenicline (V+BC) n=88 Participants Participants will... * Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Double Blind Placebo (P+BC) n=87 Participants Participants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Single Blind Enhanced Usual Care (EUC) n=86 Participants Participants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
Continuous 4-week Nicotine Vaping Abstinence at End of Treatment (Weeks 9-12)	45 Participants	12 Participants	5 Participants

SECONDARY outcome

Timeframe: Study week 12

Point-prevalence abstinence from e-cigarette use was defined as self-report of no e-cigarette use since the last visit, bioverified by saliva cotinine \<30 ng/ml. Visits with self-reported abstinence missing bioverification were treated as missing, with missingness addressed via multiple imputation.

Outcome measures

Outcome measures
Measure	Double Blind Varenicline (V+BC) n=88 Participants Participants will... * Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Double Blind Placebo (P+BC) n=87 Participants Participants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Single Blind Enhanced Usual Care (EUC) n=86 Participants Participants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
Seven-Day Point-Prevalence Nicotine Vaping Abstinence at End of Treatment (Week 12)	60 Participants	22 Participants	13 Participants

SECONDARY outcome

Timeframe: Study weeks 9, 10, 11, 12, 16, 20, 24

Point-prevalence abstinence from e-cigarette use was defined as self-report of no e-cigarette use since the last visit, bioverified by saliva cotinine \<30 ng/ml. Continuous abstinence defined as observed point-prevalence abstinence over specified study visits at weeks 9, 10, 11, 12, 16, 20, and 24. Visits with self-reported abstinence missing bioverification were treated as missing, with missingness addressed via multiple imputation.

Outcome measures

Outcome measures
Measure	Double Blind Varenicline (V+BC) n=88 Participants Participants will... * Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Double Blind Placebo (P+BC) n=87 Participants Participants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Single Blind Enhanced Usual Care (EUC) n=86 Participants Participants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
Continuous Nicotine Vaping Abstinence Over Study Weeks 9 to 24	25 Participants	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Study weeks 1-12

Minnesota Nicotine Withdrawal Scale (MNWS) total scores over study weeks 1 to 12. The MNWS is an 8-item measure assessing the severity of nicotine withdrawal symptoms. Items are scored on an ordinal scale from 0 ("not at all") to 4 ("extreme") with total scores ranging from 0 to 32. Higher scores indicate greater severity of nicotine withdrawal symptoms. Missingness due to missed visits and/or dropout was addressed via multiple imputation.

Outcome measures

Outcome measures
Measure	Double Blind Varenicline (V+BC) n=88 Participants Participants will... * Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Double Blind Placebo (P+BC) n=87 Participants Participants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Single Blind Enhanced Usual Care (EUC) n=86 Participants Participants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12) Week 4	7.2 score on a scale Standard Deviation 5.7	10.9 score on a scale Standard Deviation 6.2	9.3 score on a scale Standard Deviation 5.6
Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12) Week 6	6.8 score on a scale Standard Deviation 6.0	8.2 score on a scale Standard Deviation 5.8	8.1 score on a scale Standard Deviation 6.0
Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12) Week 7	6.3 score on a scale Standard Deviation 6.0	8.5 score on a scale Standard Deviation 5.8	7.7 score on a scale Standard Deviation 5.3
Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12) Week 9	5.4 score on a scale Standard Deviation 5.0	7.6 score on a scale Standard Deviation 5.5	8.1 score on a scale Standard Deviation 6.1
Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12) Week 11	4.6 score on a scale Standard Deviation 5.0	6.6 score on a scale Standard Deviation 5.2	7.7 score on a scale Standard Deviation 5.5
Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12) Week 1	8.7 score on a scale Standard Deviation 6.2	10.6 score on a scale Standard Deviation 5.8	10.4 score on a scale Standard Deviation 5.8
Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12) Week 2	9.2 score on a scale Standard Deviation 6.3	10.6 score on a scale Standard Deviation 6.0	10.0 score on a scale Standard Deviation 5.9
Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12) Week 3	8.2 score on a scale Standard Deviation 6.4	10.5 score on a scale Standard Deviation 5.8	9.5 score on a scale Standard Deviation 5.8
Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12) Week 5	7.1 score on a scale Standard Deviation 6.0	9.2 score on a scale Standard Deviation 6.3	8.8 score on a scale Standard Deviation 5.9
Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12) Week 8	6.2 score on a scale Standard Deviation 5.6	7.9 score on a scale Standard Deviation 5.8	7.3 score on a scale Standard Deviation 5.8
Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12) Week 10	5.1 score on a scale Standard Deviation 5.2	6.8 score on a scale Standard Deviation 5.3	7.9 score on a scale Standard Deviation 5.9
Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12) Week 12	4.5 score on a scale Standard Deviation 4.5	7.0 score on a scale Standard Deviation 6.4	7.6 score on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: Study weeks 1-12

Summed scores from the Questionnaire of Vaping Craving (QVC) over Study Weeks 1 to 12. The QVC is a 10-item self-rated validated measure (ranging from 10 to 70) of vaping craving that examines desire and intent to vape and anticipation of positive outcomes related to e-cigarette use, with higher scores indicating greater cravings to vape. Missingness due to missed visits and/or dropout are addressed with multiple imputation.

Outcome measures

Outcome measures
Measure	Double Blind Varenicline (V+BC) n=88 Participants Participants will... * Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Double Blind Placebo (P+BC) n=87 Participants Participants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Single Blind Enhanced Usual Care (EUC) n=86 Participants Participants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12) Week 5	20.4 score on a scale Standard Deviation 10.1	32.2 score on a scale Standard Deviation 12.8	32 score on a scale Standard Deviation 13.8
Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12) Week 8	17.8 score on a scale Standard Deviation 9.8	26.9 score on a scale Standard Deviation 13.6	30 score on a scale Standard Deviation 14.8
Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12) Week 9	17.1 score on a scale Standard Deviation 9.7	25.4 score on a scale Standard Deviation 13.1	31.2 score on a scale Standard Deviation 13
Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12) Week 1	34.1 score on a scale Standard Deviation 12.1	39 score on a scale Standard Deviation 12.2	37 score on a scale Standard Deviation 13
Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12) Week 2	29 score on a scale Standard Deviation 12.2	37.3 score on a scale Standard Deviation 13	36.6 score on a scale Standard Deviation 12.8
Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12) Week 3	25.8 score on a scale Standard Deviation 12.9	34.8 score on a scale Standard Deviation 12.1	34.1 score on a scale Standard Deviation 12.3
Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12) Week 4	22.8 score on a scale Standard Deviation 11.4	33.2 score on a scale Standard Deviation 13.4	34.1 score on a scale Standard Deviation 13.4
Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12) Week 6	19.3 score on a scale Standard Deviation 10.5	29.2 score on a scale Standard Deviation 13.1	32.5 score on a scale Standard Deviation 14
Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12) Week 7	18.9 score on a scale Standard Deviation 10.3	27.8 score on a scale Standard Deviation 14	31.2 score on a scale Standard Deviation 14.4
Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12) Week 10	15.9 score on a scale Standard Deviation 8.7	24 score on a scale Standard Deviation 12.2	30.4 score on a scale Standard Deviation 13.3
Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12) Week 11	16 score on a scale Standard Deviation 8.7	22.1 score on a scale Standard Deviation 11.5	28.9 score on a scale Standard Deviation 14.1
Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12) Week 12	14.4 score on a scale Standard Deviation 6.9	22 score on a scale Standard Deviation 11.2	28.1 score on a scale Standard Deviation 13.3

SECONDARY outcome

Timeframe: Study weeks 4, 8, 12

Summed scores from the General Distress Subscale of the 30-Item Mood and Anxiety Symptoms Questionnaire (MASQ-D30) over Study Weeks 4,8, and 12. The General Distress subscale of the MASQ-D30 is a 10-item self-rated validated measure (ranging from 10 to 50) of non-specific symptoms of general distress or negative affect, with higher scores indicating a greater degree of general distress. Missingness due to missed visits and/or dropout was addressed with multiple imputation.

Outcome measures

Outcome measures
Measure	Double Blind Varenicline (V+BC) n=88 Participants Participants will... * Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Double Blind Placebo (P+BC) n=87 Participants Participants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Single Blind Enhanced Usual Care (EUC) n=86 Participants Participants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
Mood and Anxiety Symptoms Questionnaire (MASQ-D30) General Distress Subscore (Weeks 4, 8, and 12) Week 8	15.6 score on a scale Standard Deviation 6.3	16.9 score on a scale Standard Deviation 6.2	16.9 score on a scale Standard Deviation 6.2
Mood and Anxiety Symptoms Questionnaire (MASQ-D30) General Distress Subscore (Weeks 4, 8, and 12) Week 4	15.8 score on a scale Standard Deviation 5.8	19 score on a scale Standard Deviation 6.5	17.9 score on a scale Standard Deviation 6.6
Mood and Anxiety Symptoms Questionnaire (MASQ-D30) General Distress Subscore (Weeks 4, 8, and 12) Week 12	15.2 score on a scale Standard Deviation 5.8	16.6 score on a scale Standard Deviation 6.3	17 score on a scale Standard Deviation 6.9

SECONDARY outcome

Timeframe: Study weeks 1-12

Population: Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.

The Neuropsychiatric Adverse Event Inventory (NAEI) is a structured interview used to assess neuropsychiatric adverse events. This outcome reports on the number of participants who reported at least one adverse event on the NAEI between the first study week (Week 1) to the end of treatment (Week 12).

Outcome measures

Outcome measures
Measure	Double Blind Varenicline (V+BC) n=88 Participants Participants will... * Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Double Blind Placebo (P+BC) n=86 Participants Participants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Single Blind Enhanced Usual Care (EUC) n=86 Participants Participants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
Neuropsychiatric Adverse Event Inventory (NAEI) Elicited Adverse Events by Week 12	71 Participants	61 Participants	78 Participants

Adverse Events

Double Blind Varenicline (V+BC)

Serious events: 1 serious events

Other events: 78 other events

Deaths: 0 deaths

Double Blind Placebo (P+BC)

Serious events: 3 serious events

Other events: 73 other events

Deaths: 0 deaths

Single Blind Enhanced Usual Care (EUC)

Serious events: 1 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Double Blind Varenicline (V+BC) n=88 participants at risk Participants will... * Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Double Blind Placebo (P+BC) n=86 participants at risk Participants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Single Blind Enhanced Usual Care (EUC) n=86 participants at risk Participants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
Psychiatric disorders Psychiatric Hospitalization	0.00% 0/88 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	2.3% 2/86 • Number of events 2 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	1.2% 1/86 • Number of events 1 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
Injury, poisoning and procedural complications Motor Vehicle Accident	1.1% 1/88 • Number of events 1 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	0.00% 0/86 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	0.00% 0/86 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
Injury, poisoning and procedural complications Snowboarding Accident	0.00% 0/88 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	1.2% 1/86 • Number of events 1 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	0.00% 0/86 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.

Other adverse events

Other adverse events
Measure	Double Blind Varenicline (V+BC) n=88 participants at risk Participants will... * Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Double Blind Placebo (P+BC) n=86 participants at risk Participants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.	Single Blind Enhanced Usual Care (EUC) n=86 participants at risk Participants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
Respiratory, thoracic and mediastinal disorders Cold symptoms	47.7% 42/88 • Number of events 69 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	33.7% 29/86 • Number of events 36 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	41.9% 36/86 • Number of events 53 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
Gastrointestinal disorders Nausea and vomiting symptoms	58.0% 51/88 • Number of events 82 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	26.7% 23/86 • Number of events 29 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	5.8% 5/86 • Number of events 6 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
Psychiatric disorders Vivid dreams	38.6% 34/88 • Number of events 46 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	16.3% 14/86 • Number of events 16 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	0.00% 0/86 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
Nervous system disorders Insomnia	30.7% 27/88 • Number of events 38 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	18.6% 16/86 • Number of events 21 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	9.3% 8/86 • Number of events 9 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
Gastrointestinal disorders Bloating	31.8% 28/88 • Number of events 32 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	25.6% 22/86 • Number of events 26 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	2.3% 2/86 • Number of events 2 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
Psychiatric disorders Anxiety disorders and symptoms	25.0% 22/88 • Number of events 37 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	32.6% 28/86 • Number of events 51 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	37.2% 32/86 • Number of events 49 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
Psychiatric disorders Mood disorders and disturbances	25.0% 22/88 • Number of events 32 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	32.6% 28/86 • Number of events 35 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	25.6% 22/86 • Number of events 31 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
Gastrointestinal disorders Constipation	15.9% 14/88 • Number of events 17 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	10.5% 9/86 • Number of events 10 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	3.5% 3/86 • Number of events 3 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
Nervous system disorders Headache	15.9% 14/88 • Number of events 16 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	22.1% 19/86 • Number of events 20 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	8.1% 7/86 • Number of events 8 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
General disorders Withdrawal symptom	8.0% 7/88 • Number of events 7 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	8.1% 7/86 • Number of events 7 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	9.3% 8/86 • Number of events 11 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
General disorders Appetite increased	5.7% 5/88 • Number of events 5 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	3.5% 3/86 • Number of events 3 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	7.0% 6/86 • Number of events 6 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.
General disorders Chest pain	0.00% 0/88 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	1.2% 1/86 • Number of events 1 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.	5.8% 5/86 • Number of events 5 • Adverse event data were collected over 24 weeks. Analysis limited to participants who received randomized treatment. Because one participant randomized to placebo (P+BC) did not receive treatment, the denominator for the analysis is 86.

Additional Information

A. Eden Evins, MD, MPH

Massachusetts General Hospital

Phone: 617-643-4679

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place