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NCT Number: NCT06566703

Testing ANSOS for Efficacy in Multi-Tribal Urban Communities

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.

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Key information

Conditions

Smokeless Tobacco Cessation Behavior Health Behavior Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

All Nations Snuff Out Smokeless (ANSOS) is a culturally tailored, group-based quit smokeless tobacco (SLT) program for American Indian (AI) people. Intervention components are described below.

Group Support Sessions: The primary component of ANSOS are four group-based support sessions, led by an AI facilitator, conducted via Zoom. All group sessions begin with team building and discussion about things people are experiencing in their lives, both those related directly to recreational tobacco use and other things that help or hinder quit attempts. The first group session is devoted to forming a cohesive group and learning about individual journeys with tobacco. Additional group sessions focus on topics covered in the education curriculum.

Individual Telephone Counseling: After initial group sessions, facilitators call participants weekly to see how they are doing, discuss personal issues related to the quitting process, and to remind them of the next group.

Educational Curriculum: The ANSOS curriculum includes 11 brochures, given throughout the program; it combines cessation information with cultural elements. Topics covered include substantial information about tobacco as a sacred plant for many, though not all, AI tribes, historical trauma, and medical/research mistrust issues, among other topics related to how to effectively quit using recreational tobacco products. Educational materials for this project will be given to participants electronically via pdf documents.

Healthy Living is an educational program primarily designed to maintain the interest of participants in the control arm in continuing into the ANSOS program after their 6-month waiting period. It includes group-based educational discussion about healthy diet, exercise, and stress management, along with educational materials on these topics. Participants also receive individual discussion with program facilitators in between group sessions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

All Nations Snuff Out Smokeless

Behavioral

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

Healthy Living

Behavioral

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 outcomes

  1. Number of participants with 7-day point prevalence abstinence

    Time frame: 6 months

    7-day point prevalence abstinence from smokeless tobacco product use

Secondary outcomes

  1. Number of participants with continuous abstinence

    Time frame: 6 months, 12 months

    Continuous abstinence from smokeless tobacco product use

Study contacts

Contact information is provided by the study sponsor or research team.

Christine M Daley, PhD

CONTACT

[email protected]

610-758-1878

Ryan Goeckner, PhD

CONTACT

[email protected]

610-758-3435

Sponsors and collaborators

Lead sponsor

Lehigh University

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Testing All Nations Snuff Out Smokeless (ANSOS) for Efficacy in Multi-Tribal Urban Communities

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 22, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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