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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA052583 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The study will test the hypothesis that varenicline, when added to behavioral and texting support for vaping cessation, will improve vaping abstinence rates in adolescents dependent on vaped nicotine over placebo plus behavioral and texting support for vaping cessation. Approximately 225 adolescents will be randomly assigned to one of three arms (1) varenicline up to 1 mg bid for 12 weeks plus behavioral and texting support for vaping cessation (V+BC), (2) identical appearing placebo plus behavioral and texting support (P+BC) and (3) enhanced usual care (EUC). The primary comparison will be the double-blind, placebo-controlled comparison of vaping cessation rates in those assigned to varenicline vs placebo.
Up to 300 adolescents, aged 16-25, who vape, do not smoke regularly, and want to quit vaping will be consented; approximately 225 eligible participants will be randomly assigned to a double blind, placebo-controlled intervention consisting of (1) varenicline or (2) identical placebo, up to 1 mg bid for 12 weeks, plus behavioral and texting support for adolescent vaping cessation or to (3) enhanced usual care. The primary comparison of interest is the double blind, placebo-controlled efficacy comparison of those assigned to (1) varenicline vs (2) placebo on vaping abstinence outcomes. The secondary comparison of placebo plus behavioral and texting support vs. EUC will estimate the efficacy of behavioral and texting support for vaping cessation in this population. The secondary comparison of varenicline plus behavioral and texting support vs EUC will estimate of the efficacy of varenicline treatment plus behavioral and texting support for vaping cessation in this population vs no treatment, the most common vaping cessation intervention. All participants will complete enrollment and baseline visits, and six monthly assessment visits. Those assigned to double blind intervention (study arms 1 or 2) will also complete 12 weekly behavioral support sessions. Assessors will be blind to intervention assignment (arm 1 or 2) vs EUC (arm 3) assignment. Among those assigned to the V+BC or P+BC intervention arms, study staff and participants will be blind to active varenicline vs placebo assignment, such that among those assigned to intervention (arm 1 or 2), assignment to study drug will be double blind. For those assigned a double blind intervention arm, study staff will distribute varenicline or identical appearing placebo and give instructions use at weeks 0, 2, 4 and 8. Participants will be asked to bring all empty and unused study medication at each in-person study visit through Week 12. The enrollment visit will consist of questionnaires, diagnostic assessments, vitals, saliva and urine samples. The baseline visit will consist of questionnaires, a saliva sample for cotinine concentration, and randomization. Monthly visits will consist of interviews, questionnaires and a saliva and urine sample. Weekly treatment meetings for participants assigned to arms 1 or 2 will consist of cognitive behavioral support and questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double Blind Varenicline (V + BC) | Experimental | Participants will...
|
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| Double Blind Placebo (P + BC) | Placebo Comparator | Participants will...
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|
| Single Blind Enhanced Usual Care (EUC) | Active Comparator | Participants will...
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double Blind Varenicline | Drug | For participants 16-17 years old, ≤ 55 kg:
For participants 16-17 years old, >55 kg:
For participants 18+ years old:
|
| Measure | Description | Time Frame |
|---|---|---|
| Continuous 4-week Nicotine Vaping Abstinence at End of Treatment (Weeks 9-12) | 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. 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. | Assessments at study weeks 9, 10, 11, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Seven-Day Point-Prevalence Nicotine Vaping Abstinence at End of Treatment (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. | Study week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eden Evins, MD | Massachusetts General Hospital | Principal Investigator |
| Randi Schuster, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Addiction Medicine | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37009114 | Background | Schuster RM, Cather C, Pachas GN, Nielsen L, Iroegbulem V, Dufour J, Potter K, Levy S, Gray KM, Evins AE. A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol. Front Psychiatry. 2023 Mar 15;14:1083791. doi: 10.3389/fpsyt.2023.1083791. eCollection 2023. | |
| 41385228 | Derived | Gilman JM, Cather C, Reeder HT, Evohr B, Pachas GN, Gray KM, McClure EA, Schuster RM, Evins AE. Cannabis Use and Nicotine Vaping Cessation Outcomes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2547799. doi: 10.1001/jamanetworkopen.2025.47799. |
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The data that support the findings of this study are available upon request. Data will include de-identified individual patient-level data, a data dictionary, and analytic code. Investigators proposing to use the data must execute a data use agreement with Massachusetts General Hospital and have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, before data is shared. Data will be available within three months of manuscript publication. Requests for data should be sent to aeevins@mgh.harvard.edu or rschuster@mgh.harvard.edu.
Beginning 3 months and ending 5 years following manuscript publication.
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Data use agreement and approval from an Institutional Review Board, Independent Ethics Committee, or Research Ethics Board are required.
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This trial recruited participants from a single U.S. state from June 2022 to November 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double Blind Varenicline (V+BC) | Participants will...
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| FG001 | Double Blind Placebo (P+BC) | Participants will...
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| FG002 | Single Blind Enhanced Usual Care (EUC) | Participants will...
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Intervention (Week 12) |
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| |||||||||||||||||||||
| Study Follow Up (Week 24) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Double Blind Varenicline (V+BC) | Participants will...
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Continuous 4-week Nicotine Vaping Abstinence at End of Treatment (Weeks 9-12) | 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. 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. | Posted | Count of Participants | Participants | Assessments at study weeks 9, 10, 11, and 12 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double Blind Varenicline (V+BC) | Participants will...
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric Hospitalization | Psychiatric disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
The sample size was underpowered to detect the observed difference in the exploratory comparison between P+ BC and EUC. Results may not generalize to those who regularly use both combustible tobacco and vaped nicotine.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A. Eden Evins, MD, MPH | Massachusetts General Hospital | 617-643-4679 | aeevins@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 10, 2024 | Mar 17, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2024 | Mar 17, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 9, 2024 | Mar 17, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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Up to 300 participants will be consented and approximately 225 participants will be randomized in a double blind, placebo-controlled, parallel-group trial comparing vaping abstinence rates in participants randomly assigned to (1) varenicline added to behavioral and texting support for vaping cessation (V+BC) and (2) identical placebo added to behavioral and texting support for vaping cessation (P+BC) (primary comparison). Exploratory secondary comparisons will be made between double blind arms 1 and 2 and the single blind (3) enhanced usual care arm.
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Eligible participants will be assigned to one of three groups using a computer-generated randomization code conducted by MGH Research Pharmacy personnel with no other interactions with participants.
The full randomization code of the two double blind treatment arms (arm 1 active varenicline and arm 2 identical placebo), and the single blind EUC arm (arm 3) will be held in the MGH research pharmacy and available to study PIs for urgent medical need only. Participants, investigators and outcome assessors will be fully blind to all 3 arms.
A partial randomization code identifying those assigned to double-blind treatment (a combined list of study IDs assigned to either study arm 1 or 2) vs single blind EUC (study arm 3) will be held by a scheduler who is not associated with outcomes assessment, data analysis or interpretation. Assignment to Arm 3, single blind EUC only, will be masked to investigators and outcomes assessors.
|
| Double Blind Placebo | Drug | For participants 16-17 years old, ≤ 55 kg:
For participants 16-17 years old, >55 kg:
For participants 18+ years old, regardless of weight:
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|
| QuitVaping | Behavioral | QuitVaping is a manualized intervention based on the American Lung Association smoking cessation program modified with adolescent appropriate content and language for vaping cessation from the vaping section of teen.smokefree.gov and the Truth Initiative. These behavioral support sessions will be delivered weekly during the 12-week treatment phase via videoconference or in- person. |
|
| This Is Quitting | Behavioral | A free, publicly available text message vaping cessation program from Truth Initiative, designed specifically to help adolescents who vape nicotine quit. Participants who set a quit date receive messages for a week preceding it and 30 days afterward that include encouragement and support, skill- and self-efficacy building exercises, coping strategies, and information about the risks of vaping, benefits of quitting and cutting down to quit. |
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| Continuous Nicotine Vaping Abstinence Over Study Weeks 9 to 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. | Study weeks 9, 10, 11, 12, 16, 20, 24 |
| Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (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. | Study weeks 1-12 |
| Questionnaire of Vaping Craving (QVC) Total Scores (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. | Study weeks 1-12 |
| Mood and Anxiety Symptoms Questionnaire (MASQ-D30) General Distress Subscore (Weeks 4, 8, and 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. | Study weeks 4, 8, 12 |
| Neuropsychiatric Adverse Event Inventory (NAEI) Elicited Adverse Events by Week 12 | 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). | Study weeks 1-12 |
| 40266580 | Derived | Evins AE, Cather C, Reeder HT, Evohr B, Potter K, Pachas GN, Gray KM, Levy S, Rigotti NA, Iroegbulem V, Dufour J, Casottana K, Costello MA, Gilman JM, Schuster RM. Varenicline for Youth Nicotine Vaping Cessation: A Randomized Clinical Trial. JAMA. 2025 Jun 3;333(21):1876-1886. doi: 10.1001/jama.2025.3810. |
| NOT COMPLETED |
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| BG001 |
| Double Blind Placebo (P+BC) |
Participants will...
|
| BG002 | Single Blind Enhanced Usual Care (EUC) | Participants will...
|
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Post-secondary School | Count of Participants | Participants |
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| E-cigarette use: Median number of days used per week in last 30 days | The median number of days per week in which a participant used e-cigarettes in last 30 days. E-cigarette use (frequency, amount) was assessed using timeline followback methods. | Due to technical issues with the timeline followback application, data was lost for 7 participants. | Median | Inter-Quartile Range | days per week |
|
| E-Cigarette Dependence Inventory (ECDI) | The Penn State Electronic Cigarette Dependence Inventory (ECDI) is a 10-item validated measure assessing electronic cigarette dependency. Scores range from 0 to 20. Higher scores indicate greater dependence. Scores indicate the following: Not dependent [score 0-3], low dependence [score 4-8], medium dependence [score 9-12], and high dependence [score ≥13]. | Mean | Standard Deviation | total score on a scale |
|
| Motivation to Quit Vaping | Motivation to quit vaping was assessed by a single-item scale from the PhenX Toolkit with scores of 1 to 10. The item reads "How motivated are you to quit vaping on a scale where 1= not at all motivated and 10= extremely motivated". Higher scores indicate greater motivation to quit. | Mean | Standard Deviation | score on a scale |
|
| Minnesota Nicotine Withdrawal Scale (MNWS) | The Minnesota Nicotine Withdrawal Scale (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. | Mean | Standard Deviation | score on a scale |
|
| Questionnaire of Vaping Craving (QVC) | The Questionnaire of Vaping Craving is a 10-item measure used to assess desire and intent to vape and anticipation of positive outcomes from vaping. Each item is scored on a 7-point Likert scale from 1 ("strongly disagree") to 7 ("strongly agree") with total scores ranging from 10 to 70. Higher scores indicate greater vaping craving. | Mean | Standard Deviation | score on a scale |
|
| Combusted Tobacco: Past 30-day use | Count of participants who reported using any combusted tobacco in the past 30 days. Past 30-day combusted tobacco use was assessed using timeline followback methods. | Due to technical issues with the timeline followback application, data was lost for 5 participants. | Count of Participants | Participants |
|
| Combusted Tobacco: Median number of days used per week in last 30 days | The median number of days per week in which a participant used combusted tobacco in the last 30 days. Combusted tobacco use (frequency, amount, type) was assessed using timeline followback methods. | Due to technical issues with the timeline followback application, data was lost for 7 participants. | Median | Inter-Quartile Range | days per week |
|
| Lifetime cigarettes smoked ≥100 | Count of participants who report smoking 100 or more cigarettes in their lifetime. Lifetime cigarette use was assessed by self-report measure. | Count of Participants | Participants |
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| Cannabis: Past 30-day use | Count of participants reporting any cannabis use in the last 30 days. Past 30-day cannabis use was assessed by timeline followback methods. | Due to technical issues with the timeline followback application, data was lost for 5 participants. | Count of Participants | Participants |
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| Cannabis: Median number of days used per week in last 30 days | The median number of days per week in which a participant used cannabis in the last 30 days. Cannabis use was assessed using timeline followback methods. | Due to technical issues with the timeline followback application, data was lost for 7 participants. | Median | Inter-Quartile Range | days per week |
|
| Cannabis Use Disorders Identification Test- Revised (CUDIT-R) | The Cannabis Use Disorders Identification Test-Revised (CUDIT-R) is a screening designed to assess problematic cannabis use. It consists of 8 self-report items that measure frequency of use, symptoms of dependence, and the negative impacts of cannabis on daily life over the past six months. Each item is scored on a scale from 0 to 4, with higher scores indiciating greater severity of cannabis-related problems. The total score can range from 0 to 32, and a score of 8 or more suggests a potential cannabis use disorder. | A total score could not be calculated for two participants due to missing items. | Median | Inter-Quartile Range | score on a scale |
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| Alcohol: Past 30-day use | Count of participants reporting any alcohol use in the last 30 days. Past 30-day alcohol use was assessed using timeline followback methods. | Count of Participants | Participants |
|
| Alcohol: Median number of days used per week in last 30 days | The median number of days per week in which a participant used alcohol in the last 30 days. Past 30-day alcohol use was assessed using timeline followback methods. | Due to technical issues with the timeline followback application, data was lost for 12 participants. | Median | Inter-Quartile Range | days per week |
|
| Alcohol Use Disorders Identification Test (AUDIT) | The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool to assess problematic alcohol use. Scores range from 0 to 40, with higher scores indicating greater likelihood that alcohol use is negatively impacting health. Scores of 8-14 indicate likely harmful/hazardous drinking and scores of 15 or greater indicate a likely alcohol use disorder. | A total score could not be calculated for 4 participants due to missing items. | Median | Inter-Quartile Range | score on a scale |
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| Any self-reported psychiatric diagnosis | Count of participants who self-reported any current psychiatric diagnosis. Self-reported psychiatric diagnoses were assessed via self-reported medical and psychiatric history. | Count of Participants | Participants |
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| Current Psychotropic Medication Use | Count of participants who reported any current psychotropic medication use. Participants were asked to self-report all concomitant medications at each study visit. | Count of Participants | Participants |
|
| Mood and Anxiety Symptoms Questionnaire (MASQ-D30) Total Score | Mood and Anxiety Symptoms Questionnaire (MASQ-D30) is a 30-item adaptation of the original 96-item MASQ, which instructs participants to rate how often in the past week they have experienced symptoms of depression and anxiety on a 5-point Likert scale from 1 ("not at all") to 5 ("extremely"). Total scores range from 30-150. Positive affect items are reverse-scored, and then a sum is calculated to reflect overall degree of mood and anxiety symptoms, with higher scores indicating more mood and anxiety symptoms. | Mean | Standard Deviation | score on a scale |
|
| Mood and Anxiety Symptoms Questionnaire (MASQ-D30): General Distress Score | Mood and Anxiety Symptoms Questionnaire (MASQ-D30) is a 30-item adaptation of the original 96-item MASQ, which instructs participants to rate how often in the past week they have experienced symptoms of depression and anxiety on a 5-point Likert scale from 1 ("not at all") to 5 ("extremely"). The general distress subscale is calculated using 10 items and has a range of 10-50. Items are summed to calculate a total score. Higher scores represent greater distress from anxiety and depression symptoms. | Mean | Standard Deviation | score on a scale |
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| OG001 | Double Blind Placebo (P+BC) | Participants will...
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| OG002 | Single Blind Enhanced Usual Care (EUC) | Participants will...
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| Secondary | Seven-Day Point-Prevalence Nicotine Vaping Abstinence at End of Treatment (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. | Posted | Count of Participants | Participants | Study week 12 |
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| Secondary | Continuous Nicotine Vaping Abstinence Over Study Weeks 9 to 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. | Posted | Count of Participants | Participants | Study weeks 9, 10, 11, 12, 16, 20, 24 |
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| Secondary | Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (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. | Posted | Mean | Standard Deviation | score on a scale | Study weeks 1-12 |
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| Secondary | Questionnaire of Vaping Craving (QVC) Total Scores (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. | Posted | Mean | Standard Deviation | score on a scale | Study weeks 1-12 |
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| Secondary | Mood and Anxiety Symptoms Questionnaire (MASQ-D30) General Distress Subscore (Weeks 4, 8, and 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. | Posted | Mean | Standard Deviation | score on a scale | Study weeks 4, 8, 12 |
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| Secondary | Neuropsychiatric Adverse Event Inventory (NAEI) Elicited Adverse Events by Week 12 | 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). | 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. | Posted | Count of Participants | Participants | Study weeks 1-12 |
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| 0 |
| 88 |
| 1 |
| 88 |
| 78 |
| 88 |
| EG001 | Double Blind Placebo (P+BC) | Participants will...
| 0 | 86 | 3 | 86 | 73 | 86 |
| EG002 | Single Blind Enhanced Usual Care (EUC) | Participants will...
| 0 | 86 | 1 | 86 | 69 | 86 |
| Motor Vehicle Accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Snowboarding Accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Nausea and vomiting symptoms | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vivid dreams | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Insomnia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Anxiety disorders and symptoms | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Mood disorders and disturbances | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Withdrawal symptom | General disorders | MedDRA | Systematic Assessment |
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| Appetite increased | General disorders | MedDRA | Systematic Assessment |
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| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001523 |
| Mental Disorders |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Regression, Logistic | Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score. | <0.001 | Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes). | Superiority |
| Regression, Logistic | Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score. | <0.001 | Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes). | Superiority |
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| Week 12 |
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| Regression, Linear | Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study group. | <0.001 | Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes). | Superiority |
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| Week 12 |
|
| Regression, Linear | Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study groups. | <0.001 | Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Omnibus tests of secondary inventory outcomes). | Superiority |
|
| Week 12 |
|
| Regression, Linear | Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study groups. | 0.02 | Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Omnibus Wald test of secondary inventory outcomes). | Superiority |
| Superiority |