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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
Select...
I use smokeless tobacco daily.
Select...
I am 18 years old or older.

Timeline

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

Find a Location

Who is running the clinical trial?

Lehigh UniversityLead Sponsor
22 Previous Clinical Trials
4,333 Total Patients Enrolled
American Cancer Society, Inc.OTHER
228 Previous Clinical Trials
106,989 Total Patients Enrolled
Christine M Daley, PhDPrincipal InvestigatorLehigh University
1 Previous Clinical Trials
576 Total Patients Enrolled
~192 spots leftby Feb 2026
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