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

Tracking Information

• First Submitted Date: March 12, 2019
• First Posted Date: March 14, 2019
• Last Update Posted Date: July 22, 2020
• Actual Study Start Date: May 30, 2019
• Actual Primary Completion Date: May 21, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 13, 2019)

• 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
• 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.

Original Primary Outcome Measures (submitted: March 12, 2019)

• 90 day continuous abstinence [ Time Frame: 90 days ]
  whether participant smoked between baseline and 3-month follow-up
• 7 day abstinence [ Time Frame: 7 days ]
  whether participant smoked during the past 7 days at follow-up

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Text Messaging-Based Smoking Cessation Program for Homeless Youth
• Official Title: Text Messaging-Based Smoking Cessation Program for Homeless Youth
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Cigarette Smoking

Intervention

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

Study Arms

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

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 12, 2020): 77
• Original Estimated Enrollment (submitted: March 12, 2019): 80
• Actual Study Completion Date: May 21, 2020
• Actual Primary Completion Date: May 21, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 25 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03874585
• Other Study ID Numbers: 27IP-0051
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Joan Tucker, RAND
• Study Sponsor: RAND
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: RAND
• Verification Date: July 2020