Recruiting

ANSOS

Sponsor:

Lehigh University

Code:

NCT06566703

Conditions

Smokeless Tobacco Cessation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

All Nations Snuff Out Smokeless

Healthy Living

Study Details

Brief summary:

This is a wait-list control trial to test for efficacy of the All Nations Snuff Out Smokeless (ANSOS) recreational tobacco cessation program in multi-tribal American Indian (AI) communities. Participants randomized to the control arm are provided with a Healthy Living educational intervention while they wait for the program to encourage them to remain engaged with the study team during the six-month waiting period. Participants from the ANSOS arm are offered the Healthy Living educational intervention after they complete the 6-month outcome measures.

Conditions

Smokeless Tobacco Cessation

Study ID

NCT06566703

Start date

Aug 18, 2023

Status verified date

Jun, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 18 and over
  • Stable telephone number that can be used for the purpose of the study
  • Willing to be followed for 12 months and participate in study activities
  • Able to attend Zoom sessions
  • Current SLT user, at least once per day
  • Self-reported AI

Exclusion Criteria:

  • Cannot provide a stable phone number for 12 months for the purpose of the study
  • Unable to attend Zoom sessions

Study Design

Enrollment

384 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: All Nation Snuff Out Smokeless

This is a culturally targeted smokeless tobacco cessation program developed for American Indian communities. It includes group sessions via Zoom, individual telephone counseling, and educational materials.

experimental: Wait List Control - Healthy Living

Participants randomized to this arm are provided with information about healthy living while they wait for their turn at the intervention arm. Participants learn about diet, exercise, and stress reduction. They receive the All Nations Snuff Out Smokeless intervention after a six-month waiting period.

Interventions

All Nations Snuff Out Smokeless

All Nations Snuff Out Smokeless is a culturally tailored smokeless tobacco cessation program that incorporates group-based and individual counseling.

Healthy Living

Healthy Living is an educational program that provides information about diet, exercise, stress, and general health. It uses group-based and individual discussion, along with educational materials.

Primary outcome measure

  • Number of participants with 7-day point prevalence abstinence [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Christine M Daley, PhD

610-758-1878cmdaley@lehigh.edu

Ryan Goeckner, PhD

610-758-3435rtgoeckner@gmail.com

Locations

Lehigh University

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Contacts

Christine M Daley, PhD

610-758-1878cmdaley@lehigh.edu

Ryan Goeckner, PhD

610-758-3435rtgoeckner@gmail.com

More Information

Sponsor

Lehigh University

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • American Indian
  • smokeless tobacco cessation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Lehigh University on 2026-06-25.