Trial Outcomes & Findings for Changing the Default for Tobacco Treatment (NCT NCT02721082)
NCT ID: NCT02721082
Last Updated: 2022-12-01
Results Overview
7-day, self-reported and verified cigarette abstinence.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1000 participants
Primary outcome timeframe
Month 1
Results posted on
2022-12-01
Participant Flow
Participant milestones
| Measure |
Opt Out
Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out". Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy.
Opt Out Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
Nicotine Replacement Therapy: Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
Opt In
Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.
Opt In Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
Nicotine Replacement Therapy: Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
|---|---|---|
|
Overall Study
STARTED
|
655
|
345
|
|
Overall Study
COMPLETED
|
469
|
270
|
|
Overall Study
NOT COMPLETED
|
186
|
75
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Changing the Default for Tobacco Treatment
Baseline characteristics by cohort
| Measure |
Opt Out
n=469 Participants
Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out". Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy.
Opt Out Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
Nicotine Replacement Therapy: Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
Opt In
n=270 Participants
Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.
Opt In Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
Nicotine Replacement Therapy: Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
Total
n=739 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.21 years
STANDARD_DEVIATION 14.80 • n=5 Participants
|
51.70 years
STANDARD_DEVIATION 14.56 • n=7 Participants
|
51.39 years
STANDARD_DEVIATION 14.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
226 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
243 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
390 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
270 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
428 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
83 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic multiracial
|
75 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
32 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
469 participants
n=5 Participants
|
270 participants
n=7 Participants
|
739 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: We calculated the Bayesian Posterior Probability (BPP) and Bayesian 95% Credible Intervals for all outcomes. ClinicalTrials.gov has no option to select these, so the labels for the credible intervals will appear as "confidence intervals"
7-day, self-reported and verified cigarette abstinence.
Outcome measures
| Measure |
Opt Out
n=469 Participants
Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out". Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy.
Opt Out Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
Nicotine Replacement Therapy: Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
Opt In
n=270 Participants
Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.
Opt In Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
Nicotine Replacement Therapy: Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
|---|---|---|
|
7-day Point-prevalence Abstinence
|
21.5 Percentage of participants quit at 1-mo
Interval 17.9 to 25.4
|
15.8 Percentage of participants quit at 1-mo
Interval 11.8 to 20.5
|
SECONDARY outcome
Timeframe: Month 1Population: Accepted a post-discharge script for medication
Percentages of participants who use cessation medications and participate in counseling post discharge
Outcome measures
| Measure |
Opt Out
n=469 Participants
Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out". Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy.
Opt Out Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
Nicotine Replacement Therapy: Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
Opt In
n=270 Participants
Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.
Opt In Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
Nicotine Replacement Therapy: Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
|---|---|---|
|
Treatment Engagement
|
87.68 Percentage of participants w/script
Interval 84.5 to 90.54
|
37.84 Percentage of participants w/script
Interval 32.18 to 43.75
|
SECONDARY outcome
Timeframe: Month 1Population: BPP and credible intervals
We will assess the impact of opt-out versus opt-in treatment on perceived treatment coercion using items adapted from the Admission Experience Survey (AES) short form.
Outcome measures
| Measure |
Opt Out
n=469 Participants
Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out". Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy.
Opt Out Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
Nicotine Replacement Therapy: Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
Opt In
n=270 Participants
Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.
Opt In Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
Nicotine Replacement Therapy: Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
|---|---|---|
|
Default-theory Based Measures
|
88.41 % felt they had control over quitting
Interval 85.19 to 91.28
|
86.64 % felt they had control over quitting
Interval 82.07 to 90.63
|
SECONDARY outcome
Timeframe: Month 67-day, self-reported and verified cigarette abstinence.
Outcome measures
| Measure |
Opt Out
n=469 Participants
Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out". Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy.
Opt Out Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
Nicotine Replacement Therapy: Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
Opt In
n=270 Participants
Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.
Opt In Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
Nicotine Replacement Therapy: Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
|---|---|---|
|
7-day Point-prevalence Abstinence
|
18.57 Percentage of participants quit at 6-mo
Interval 15.0 to 22.4
|
17.90 Percentage of participants quit at 6-mo
Interval 13.2 to 23.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Counselor time, wage estimates, pharmacotherapy costs, and abstinence rates will be combined to report the incremental cost-effective ratio (ICER). The ICER is the ratio of the difference in costs divided by the difference in effectiveness between the two study arms. ICER indicates the added cost per additional quitter, a metric that will allow comparisons to other smoking cessation economic studies.
Outcome measures
Outcome data not reported
Adverse Events
Opt Out
Serious events: 191 serious events
Other events: 0 other events
Deaths: 27 deaths
Opt In
Serious events: 89 serious events
Other events: 0 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Opt Out
n=655 participants at risk
Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out". Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy.
Opt Out Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
Nicotine Replacement Therapy: Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
Opt In
n=345 participants at risk
Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.
Opt In Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
Nicotine Replacement Therapy: Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
|
|---|---|---|
|
General disorders
Death, Hospitalization, or Life threatening illness
|
29.2%
191/655 • Number of events 191 • Adverse event data were collect for 6 months following randomization
Definitions do not differ from those of clinicaltrials.gov
|
25.8%
89/345 • Number of events 89 • Adverse event data were collect for 6 months following randomization
Definitions do not differ from those of clinicaltrials.gov
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place