NCT01509586

Brief Summary

This nationwide telephone and mail- based research study will recruit 1,400 cigarette smokers who are not motivated to quit to test the effects of a marketed oral, non-combustible smokeless tobacco product on cigarette smoking behaviors. It will also track the participants' usage patterns of the smokeless tobacco product. Half of the participants will receive a new, potentially safer tobacco product during the first six weeks of the study, and half will not. During this six-week period, each participant will complete three brief phone interviews. After this first six week period, participants will complete 6 other brief follow-up interviews, where they will answer questionnaires about their smoking habits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 1, 2016

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

4.3 years

First QC Date

December 14, 2011

Results QC Date

June 20, 2016

Last Update Submit

July 7, 2023

Conditions

SmokingSmoking Cessation

Keywords

smokingsmoking cessationPotentially Reduced Exposure Products (PREPs)

Outcome Measures

Primary Outcomes (1)

  • Quit Attempts and Abstinence

    % 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

    From study enrollment through end of one-year follow up

Study Arms (2)

PREP (Potentially Reduced Exposure Product) Group

EXPERIMENTAL
Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product

cigarette group

NO INTERVENTION

Interventions

Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco productDRUG

The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.

PREP (Potentially Reduced Exposure Product) Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>=19
  • a daily cigarette smoker of \>=10 cigs/day
  • English speaking
  • live in the contiguous U.S.
  • unmotivated to quit smoking in the next 30 days

You may not qualify if:

  • no use of smokeless tobacco in past six months
  • not breastfeeding, pregnant, or planning a pregnancy
  • devoid of any recent (past 6 months) cardiovascular trauma
  • no quit attempt of \>=1 week in past 6 months
  • no use of pharmacotherapy to quit smoking in past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Carpenter MJ, Wahlquist AE, Burris JL, Gray KM, Garrett-Mayer E, Cummings KM, Alberg AJ. Snus undermines quit attempts but not abstinence: a randomised clinical trial among US smokers. Tob Control. 2017 Mar;26(2):202-209. doi: 10.1136/tobaccocontrol-2015-052783. Epub 2016 Apr 12.

    PMID: 27071730DERIVED

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Results Point of Contact

Title
Dr. Matthew J. Carpenter
Organization
Medical University of South Carolina
carpente@musc.edu
843-876-2436

Study Officials

  • Matthew J. Carpenter, Ph.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2011

First Posted

January 13, 2012

Study Start

November 1, 2011

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 12, 2023

Results First Posted

August 1, 2016

Record last verified: 2023-07

Locations

US(1)