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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03874585
Other study ID # 27IP-0051
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date May 30, 2019
Est. completion date May 21, 2020

Study information

Verified date July 2020
Source RAND
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date May 21, 2020
Est. primary completion date May 21, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Los Angeles LGBT Center Youth Center Los Angeles California
United States My Friend's Place Los Angeles California
United States Safe Place for Youth Venice California

Sponsors (1)

Lead Sponsor Collaborator
RAND

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 90 day continuous abstinence Participants will self-report whether they have smoked any cigarettes between baseline and 3-month follow-up 90 days
Primary 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
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