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Text Messaging-Based Smoking Cessation Program for Homeless Youth

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

Tracking Information
First Submitted Date  ICMJE March 12, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date July 22, 2020
Actual Study Start Date  ICMJE May 30, 2019
Actual Primary Completion Date May 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Text Messaging-Based Smoking Cessation Program for Homeless Youth
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cigarette Smoking
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2020)
77
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2019)
80
Actual Study Completion Date  ICMJE May 21, 2020
Actual Primary Completion Date May 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03874585
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Joan Tucker, RAND
Study Sponsor  ICMJE RAND
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account RAND
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP