Trial · NCT01509586

A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco

NCT01509586, Not applicable, Completed, Medical University of South Carolina; results first posted 2016-08-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco. Trials, record NCT01509586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01509586

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
NCT number: NCT01509586
Status: Completed
Phases: Not applicable
Enrollment: 1,236 participants, actual
Lead sponsor: Medical University of South Carolina
Conditions: Smoking, Smoking Cessation
Interventions: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product
First posted: 2012-01-13
Last updated: 2023-07-12
Results first posted: 2016-08-01

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Quit Attempts and Abstinence	From study enrollment through end of one-year follow up	% of study participants making a quit attempt or staying abstinent from smoking during the study Notes: Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Quit Attempts and Abstinence	From study enrollment through end of one-year follow up		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Quit Attempts and Abstinence	PREP (Potentially Reduced Exposure Product) Group	Any quit attempt, ever within study	25.7	percentage of participants
Quit Attempts and Abstinence	Cigarette Group	Any quit attempt, ever within study	30.8	percentage of participants
Quit Attempts and Abstinence	PREP (Potentially Reduced Exposure Product) Group	Any 24 h quit attempt, ever within study	19.8	percentage of participants
Quit Attempts and Abstinence	Cigarette Group	Any 24 h quit attempt, ever within study	25.6	percentage of participants
Quit Attempts and Abstinence	PREP (Potentially Reduced Exposure Product) Group	Floating abstinence	14.9	percentage of participants
Quit Attempts and Abstinence	Cigarette Group	Floating abstinence	16.2	percentage of participants
Quit Attempts and Abstinence	PREP (Potentially Reduced Exposure Product) Group	Week 32 PPA	6.2	percentage of participants
Quit Attempts and Abstinence	Cigarette Group	Week 32 PPA	5.6	percentage of participants
Quit Attempts and Abstinence	PREP (Potentially Reduced Exposure Product) Group	Week 58 PPA	5.1	percentage of participants
Quit Attempts and Abstinence	Cigarette Group	Week 58 PPA	5.6	percentage of participants

Source ClinicalTrials.gov

Participant flow22

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PREP (Potentially Reduced Exposure Product) Group	626
Overall Study	STARTED	Cigarette Group	610
Overall Study	Week 3	PREP (Potentially Reduced Exposure Product) Group	574
Overall Study	Week 3	Cigarette Group	585
Overall Study	Week 6	PREP (Potentially Reduced Exposure Product) Group	551
Overall Study	Week 6	Cigarette Group	585
Overall Study	Week 10	PREP (Potentially Reduced Exposure Product) Group	537
Overall Study	Week 10	Cigarette Group	574
Overall Study	Week 14	PREP (Potentially Reduced Exposure Product) Group	528
Overall Study	Week 14	Cigarette Group	566

1 to 10 of 22Source ClinicalTrials.gov

See all 22 participant flow

Adverse events26

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
other	nausea	Gastrointestinal disorders	PREP (Potentially Reduced Exposure Product) Group	93	626
other	nausea	Gastrointestinal disorders	Cigarette Group	82	610
other	headache	General disorders	PREP (Potentially Reduced Exposure Product) Group	79	626
other	headache	General disorders	Cigarette Group	93	610
other	heartburn	Gastrointestinal disorders	PREP (Potentially Reduced Exposure Product) Group	68	626
other	heartburn	Gastrointestinal disorders	Cigarette Group	51	610
other	mouth soreness	Gastrointestinal disorders	PREP (Potentially Reduced Exposure Product) Group	46	626
other	mouth soreness	Gastrointestinal disorders	Cigarette Group	43	610
other	dizziness or lightheadnedness	General disorders	PREP (Potentially Reduced Exposure Product) Group	54	626
other	dizziness or lightheadnedness	General disorders	Cigarette Group	61	610

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PREP (Potentially Reduced Exposure Product) Group
Total, all-cause mortality	Cigarette Group
Total, other adverse events	PREP (Potentially Reduced Exposure Product) Group	458	626
Total, other adverse events	Cigarette Group	414	610
Total, serious adverse events	PREP (Potentially Reduced Exposure Product) Group	3	626
Total, serious adverse events	Cigarette Group	3	610

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27071730	DERIVED

Source PubMed

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
R01CA154992	A Novel Trial of Smokeless Tobacco for Cessation Induction in Unmotivated Smokers	CARPENTER, MATTHEW J	MEDICAL UNIVERSITY OF SOUTH CAROLINA	NATIONAL CANCER INSTITUTE	2011 to 2015

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
PREP (Potentially Reduced Exposure Product) Group vs Cigarette Group: serious adverse events

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01509586

GET https://conductscience.org/api/trials/v1/NCT01509586/flow?page=2

API reference For AI assistants