Trial · NCT02721082
Changing the Default for Tobacco Treatment
NCT02721082, Phase 4, Completed, University of Kansas Medical Center; results first posted 2022-12-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Changing the Default for Tobacco Treatment. Trials, record NCT02721082. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02721082
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Changing the Default for Tobacco Treatment
- NCT number
- NCT02721082
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,000 participants, actual
- Lead sponsor
- University of Kansas Medical Center
- Conditions
- Tobacco Use Cessation
- Interventions
- Opt Out Treatment Program, Nicotine Replacement Therapy, Opt In Treatment Program, Nicotine Replacement Therapy
- First posted
- 2016-03-28
- Last updated
- 2022-12-01
- Results first posted
- 2022-12-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 7-day Point-prevalence Abstinence | Month 1 | 7-day, self-reported and verified cigarette abstinence. |
| Secondary | Treatment Engagement | Month 1 | Percentages of participants who use cessation medications and participate in counseling post discharge |
| Secondary | Default-theory Based Measures | Month 1 | 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. |
| Secondary | 7-day Point-prevalence Abstinence | Month 6 | 7-day, self-reported and verified cigarette abstinence. |
| Other | Cost-effectiveness | Month 6 | Counselor 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 7-day Point-prevalence Abstinence | Month 1 | 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 | Percentage of participants quit at 1-mo | MEAN |
| SECONDARY | Treatment Engagement | Month 1 | Accepted a post-discharge script for medication | Percentage of participants w/script | MEAN |
| SECONDARY | Default-theory Based Measures | Month 1 | BPP and credible intervals | % felt they had control over quitting | MEAN |
| SECONDARY | 7-day Point-prevalence Abstinence | Month 6 | Percentage of participants quit at 6-mo | MEAN | |
| OTHER_PRE_SPECIFIED | Cost-effectiveness | Month 6 |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 7-day Point-prevalence Abstinence | Opt Out | 21.5 | 95% Confidence Interval 17.9 to 25.4 | Percentage of participants quit at 1-mo | |
| 7-day Point-prevalence Abstinence | Opt In | 15.8 | 95% Confidence Interval 11.8 to 20.5 | Percentage of participants quit at 1-mo | |
| Treatment Engagement | Opt Out | 87.68 | 95% Confidence Interval 84.50 to 90.54 | Percentage of participants w/script | |
| Treatment Engagement | Opt In | 37.84 | 95% Confidence Interval 32.18 to 43.75 | Percentage of participants w/script | |
| Default-theory Based Measures | Opt Out | 88.41 | 95% Confidence Interval 85.19 to 91.28 | % felt they had control over quitting | |
| Default-theory Based Measures | Opt In | 86.64 | 95% Confidence Interval 82.07 to 90.63 | % felt they had control over quitting | |
| 7-day Point-prevalence Abstinence | Opt Out | 18.57 | 95% Confidence Interval 15.0 to 22.4 | Percentage of participants quit at 6-mo | |
| 7-day Point-prevalence Abstinence | Opt In | 17.90 | 95% Confidence Interval 13.2 to 23.1 | Percentage of participants quit at 6-mo |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Opt Out | 655 | |
| Overall Study | STARTED | Opt In | 345 | |
| Overall Study | COMPLETED | Opt Out | 469 | |
| Overall Study | COMPLETED | Opt In | 270 | |
| Overall Study | NOT COMPLETED | Opt Out | 186 | |
| Overall Study | NOT COMPLETED | Opt In | 75 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Death, Hospitalization, or Life threatening illness | General disorders | Opt Out | 191 | 655 | 191 |
| serious | Death, Hospitalization, or Life threatening illness | General disorders | Opt In | 89 | 345 | 89 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Opt Out | 27 | 655 |
| Total, all-cause mortality | Opt In | 19 | 345 |
| Total, other adverse events | Opt Out | 0 | 655 |
| Total, other adverse events | Opt In | 0 | 345 |
| Total, serious adverse events | Opt Out | 191 | 655 |
| Total, serious adverse events | Opt In | 89 | 345 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HL131512 | Changing the Default for Tobacco Treatment | RICHTER, KIMBER P | UNIVERSITY OF KANSAS MEDICAL CENTER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2016 to 2020 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Opt Out vs Opt In: deaths from any cause | Trial comparisons |
| Opt Out vs Opt In: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02721082
GET https://conductscience.org/api/trials/v1/NCT02721082/registered