NCT04315506

Brief Summary

Participants will be randomly assigned (like the flip of a coin) to one of the two groups after completing the baseline survey. Participants have a 50% of being in either the #EnufSnuff.TXT intervention group or the Enough Snuff Intervention group. Participants will then be given a baseline survey and the intervention will be explained to them.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
532

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration 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

First Submitted

Initial submission to the registry

March 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 17, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

2.3 years

First QC Date

March 18, 2020

Results QC Date

January 12, 2024

Last Update Submit

July 16, 2024

Conditions

Smokeless Tobacco Cessation

Keywords

smokeless tobaccoquitting smokeless tobacco

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Did Not Use Chew/Dip in the Past 7 Days (Quit)

    Measured by self-report. Number of participants who replied "no" the following: "In the past 7 days, have you used chew/dip?- Yes or No".

    6 months post-randomization

Secondary Outcomes (2)

  • Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS)

    Baseline, 3 months, and 6 months post-randomization

  • Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ)

    Baseline, 3 months, and 6 months post-randomization

Study Arms (2)

#EnufSnuff.TXT Intervention

EXPERIMENTAL

Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage.

Behavioral: #EnufSnuff.TXT Intervention

Enough Snuff Intervention

ACTIVE COMPARATOR

Participants in this arm will be given the Enuff Snuff cessation manual.

Behavioral: Enough Snuff Intervention

Interventions

#EnufSnuff.TXT InterventionBEHAVIORAL

The SGR program will reduce smokeless tobacco until you reach zero. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages.

#EnufSnuff.TXT Intervention
Enough Snuff InterventionBEHAVIORAL

Participants will be sent the Enough Snuff cessation manual. One weeks after it is sent, participants will then receive text messages from the study team twice a week for ten weeks.

Enough Snuff Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) 18 years of age and older
  • \) Have used smokeless tobacco for the last year, currently dip 3 or more times a day
  • \) Have an address in a rural census tract defined by a RUCC code of 4-10 and/or an IMU of 62 or lower
  • \) Interested in participating in a cessation program; and
  • \) Have access to a cell phone with unlimited texting ability.

You may not qualify if:

  • \) Non-English speaking;
  • \) Have smoked cigarettes or used any other tobacco product in the past 30 days (i.e., dual user) and are not willing to abstain during the intervention period
  • \) Currently participating in a smokeless tobacco cessation study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

Related Publications (1)

  • Noonan D, Silva SG, Fish LJ, Simmons LA, Nwankwo N, Scherr K, Da Costa M, Sang E, Sanders C, Swinkels C, Garcia Ortiz N, Severson HH, Pollak KI. Randomized Controlled Trial of a Text-Based Smokeless Tobacco Cessation Intervention for Rural and Medically Underserved Communities. Nicotine Tob Res. 2024 Dec 23;27(1):132-142. doi: 10.1093/ntr/ntae182.

    PMID: 39030750DERIVED

MeSH Terms

Conditions

Tobacco Use CessationTobacco Use

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Devon Noonan
Organization
Duke University
devon.noonan@duke.edu
919-684-3786

Study Officials

  • Devon Noonan, PhD

    Duke University

    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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2020

First Posted

March 19, 2020

Study Start

October 16, 2020

Primary Completion

January 28, 2023

Study Completion

January 28, 2023

Last Updated

July 17, 2024

Results First Posted

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)