Testing ANSOS for Efficacy in Multi-Tribal Urban Communities

ConditionSmokeless Tobacco Cessation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorLehigh University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Cannot provide a stable phone number for 12 months for the purpose of the study

Unable to attend Zoom sessions

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

384 Participants

are divided into 2 treatment groups

Group A: All Nation Snuff Out SmokelessExperimental treatment 2 interventions

Group B: Wait List Control - Healthy LivingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Number of participants with 7-day point prevalence abstinence

7-day point prevalence abstinence from smokeless tobacco product use

Time frame

6 months

Secondary outcomes

Number of participants with continuous abstinence

Continuous abstinence from smokeless tobacco product use

Time frame

6 months, 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lehigh University

Lead sponsor

American Cancer Society, Inc.

Collaborator

Source ClinicalTrials.gov

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