- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03874585
Text Messaging-Based Smoking Cessation Program for Homeless Youth
July 20, 2020 updated by: Joan Tucker, RAND
Unaccompanied homeless youth smoke at much higher rates than non-homeless adolescents and young adults.
Many homeless youth smokers are motivated to quit; yet, strategies specifically developed for this vulnerable population are lacking.
This study will develop and pilot test a text messaging intervention (also known as a TMI) to help homeless youth quit smoking.
Text messaging can provide ongoing support for homeless youth during a quit attempt, which is important given that these youth tend to be highly mobile and lack regular access to health services.
Participants in this study will be homeless youth who currently smoke and are motivated to quit smoking.
All participants will receive a 30-minute group-based smoking cessation counseling session and a nicotine replacement product.
Half of these smokers will also receive the TMI, for 6 weeks following the group counseling session, which will provide ongoing support for quitting.
The main goal of this study is to investigate whether receiving the TMI results in greater reductions in cigarette smoking over a 3-month period compared to receiving the group counseling session alone.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Los Angeles, California, United States, 90028
- My Friend's Place
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Los Angeles, California, United States, 90038
- Los Angeles LGBT Center Youth Center
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Venice, California, United States, 90291
- Safe Place for Youth
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- between ages of 18-25
- seeking services at one of the participating drop-in centers for homeless youth
- smoked at least 5 cigarettes per day on at least 20 days in the past month
- motivated to quit in next 30 days
- has a cell phone to receive text messages and willing to receive text messages
Exclusion Criteria:
- currently pregnant or breastfeeding, or planning to become pregnant or breastfeed in the next 6 months
- has a medical condition (based on self-report) which would prevent using the nicotine replacement product
- used pharmacotherapy to reduce or stop smoking in the past 30 days
- currently receiving other smoking cessation services
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Condition
Participants in the standard condition will receive a 30-minute group-based smoking cessation counseling session based on the 5 A's approach (Ask; Advise; Assess; Assist; Arrange) and free nicotine replacement.
|
Participants will receive a 30-minute group smoking cessation counseling session and a supply of nicotine replacement.
|
Experimental: Enhanced Condition
Participants in the standard condition will receive a 30-minute group-based smoking cessation counseling session based on the 5 A's approach (Ask; Advise; Assess; Assist; Arrange), free nicotine replacement, and the 6-week text messaging intervention.
|
Participants will receive a 30-minute group smoking cessation counseling session, a supply of nicotine replacement, and the 6-week text messaging intervention to provide ongoing support for quitting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
90 day continuous abstinence
Time Frame: 90 days
|
Participants will self-report whether they have smoked any cigarettes between baseline and 3-month follow-up
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90 days
|
7 day abstinence
Time Frame: 7 days
|
Participants will self-report whether they have smoked any cigarettes in the past 7 days.
Self-reported abstinence will be biochemically verified.
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7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pedersen ER, Linnemayr S, Shadel WG, Zutshi R, DeYoreo M, Cabreros I, Tucker JS. Substance Use and Mental Health Outcomes from a Text Messaging-Based Intervention for Smoking Cessation Among Young People Experiencing Homelessness. Nicotine Tob Res. 2022 Jan 1;24(1):130-134. doi: 10.1093/ntr/ntab160.
- Tucker JS, Linnemayr S, Pedersen ER, Shadel WG, Zutshi R, DeYoreo M, Cabreros I. Pilot Randomized Clinical Trial of a Text Messaging-Based Intervention for Smoking Cessation Among Young People Experiencing Homelessness. Nicotine Tob Res. 2021 Aug 29;23(10):1691-1698. doi: 10.1093/ntr/ntab055.
- Linnemayr S, Zutshi R, Shadel W, Pedersen E, DeYoreo M, Tucker J. Text Messaging Intervention for Young Smokers Experiencing Homelessness: Lessons Learned From a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Apr 1;9(4):e23989. doi: 10.2196/23989.
- Tucker JS, Pedersen ER, Linnemayr S, Shadel WG, DeYoreo M, Zutshi R. A text message intervention for quitting cigarette smoking among young adults experiencing homelessness: study protocol for a pilot randomized controlled trial. Addict Sci Clin Pract. 2020 Feb 19;15(1):11. doi: 10.1186/s13722-020-00187-6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2019
Primary Completion (Actual)
May 21, 2020
Study Completion (Actual)
May 21, 2020
Study Registration Dates
First Submitted
March 12, 2019
First Submitted That Met QC Criteria
March 12, 2019
First Posted (Actual)
March 14, 2019
Study Record Updates
Last Update Posted (Actual)
July 22, 2020
Last Update Submitted That Met QC Criteria
July 20, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27IP-0051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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