NCT03874585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 30, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

March 12, 2019

Last Update Submit

July 20, 2020

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (2)

  • 90 day continuous abstinence

    Participants will self-report whether they have smoked any cigarettes between baseline and 3-month follow-up

    90 days

  • 7 day abstinence

    Participants will self-report whether they have smoked any cigarettes in the past 7 days. Self-reported abstinence will be biochemically verified.

    7 days

Study Arms (2)

Standard Condition

ACTIVE COMPARATOR

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

Enhanced Condition

EXPERIMENTAL

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

Interventions

Group counseling and nicotine replacementBEHAVIORAL

Participants will receive a 30-minute group smoking cessation counseling session and a supply of nicotine replacement.

Standard Condition
Group counseling, nicotine replacement, and text messaging supportBEHAVIORAL

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

Enhanced Condition

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

My Friend's Place

Los Angeles, California, 90028, United States

Location

Los Angeles LGBT Center Youth Center

Los Angeles, California, 90038, United States

Location

Safe Place for Youth

Venice, California, 90291, United States

Location

Related Publications (4)

  • 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.

    PMID: 34375409DERIVED

  • 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.

    PMID: 33852730DERIVED

  • 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.

    PMID: 33792551DERIVED

  • 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.

    PMID: 32075695DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Behavioral Scientist

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 14, 2019

Study Start

May 30, 2019

Primary Completion

May 21, 2020

Study Completion

May 21, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(3)