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Behavioral Intervention

ANSOS for Smokeless Tobacco Cessation

N/A

Recruiting

Led By Christine M Daley, PhD

Research Sponsored by Lehigh University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current SLT user, at least once per day

Age 18 and over

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effectiveness of a tobacco cessation program called All Nations Snuff Out Smokeless (ANSOS) in American Indian communities. One group of participants will receive the ANSOS program immediately

Who is the study for?

This trial is for members of multi-tribal American Indian communities who want to quit using smokeless tobacco. There are no specific inclusion or exclusion criteria provided, but typically participants would need to be users of smokeless tobacco and willing to follow the study procedures.

What is being tested?

The trial is testing the 'All Nations Snuff Out Smokeless' (ANSOS) program against a 'Healthy Living' educational intervention. Participants are randomly placed in either the ANSOS program or put on a waitlist and given Healthy Living education first.

What are the potential side effects?

Since this trial involves educational interventions rather than medical treatments, there may not be direct side effects like those associated with drugs. However, participants might experience stress or discomfort related to quitting tobacco.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I use smokeless tobacco daily.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with 7-day point prevalence abstinence

Secondary study objectives

Number of participants with continuous abstinence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Wait List Control - Healthy LivingExperimental Treatment2 Interventions

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.

Group II: All Nation Snuff Out SmokelessExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Healthy Living

2012

N/A

~1750

0 / 2Eligibility criteria met