Text Messaging-Based Smoking Cessation Program for Homeless Youth

• ClinicalTrials.gov Identifier: NCT03874585
• Recruitment Status: Completed
• First Posted: March 14, 2019
• Last Update Posted: July 22, 2020
• Sponsor: RAND
• Information provided by (Responsible Party): Joan Tucker, RAND

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cigarette Smoking	Behavioral: Group counseling and nicotine replacement; Behavioral: Group counseling, nicotine replacement, and text messaging support	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Text Messaging-Based Smoking Cessation Program for Homeless Youth
• Actual Study Start Date: May 30, 2019
• Actual Primary Completion Date: May 21, 2020
• Actual Study Completion Date: May 21, 2020

Arms and Interventions

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.	Behavioral: Group counseling and 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.	Behavioral: Group counseling, nicotine replacement, and text messaging support; 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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 25 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

My Friend's Place

Los Angeles, California, United States, 90028

Los Angeles LGBT Center Youth Center

Los Angeles, California, United States, 90038

Safe Place for Youth

Venice, California, United States, 90291

Sponsors and Collaborators

RAND

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Joan Tucker, Senior Behavioral Scientist, RAND
• ClinicalTrials.gov Identifier: NCT03874585
• Other Study ID Numbers: 27IP-0051
• First Posted: March 14, 2019
• Last Update Posted: July 22, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action