SmokefreeSGM, A Text-based Smoking Cessation Feasibility Trial for Sexual and Gender Minority Groups

Smoking Cessation Clinical Trial

Official title:

SmokefreeSGM, A Text-based Smoking Cessation Feasibility Trial for Sexual and Gender Minority Groups

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645354
• Other study ID #: HSC-SPH-22-0717
• Secondary ID: K22CA237639
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: November 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Irene Tami-Maury, DMD,MSc,DrPH-NHSN
• Phone: 713-500-9234
• Email: Irene.M.Tami-Maury[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the feasibility and acceptability of Smokefree Sexual and Gender Minority (SGM), an SGM-tailored version of the SmokefreeTXT text messaging program

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Self-identify as an LGBTQ+ individual

• Currently live in Texas

• Have smoked at least 100 cigarettes in their lifetime, smoke every day, and smoke greater than or equal to 5 cigarettes a day

• Are willing to quit smoking in the next 15 days

• Have a cell phone number with an unlimited short message service (SMS) plan

• Have a positive cotinine saliva test to indicate their smoking status

Exclusion Criteria:

• Have a prepaid cell phone plan (pay-as-you-go plan)

• Have a cell phone number that does not work and/or is registered to someone else

• Have inadequate equipment/devices (i.e., webcam, speakers, mic) for participating in telehealth sessions via Microsoft Teams, Webex, or Zoom AND cannot meet in-person

• Pregnant or breastfeeding persons (nicotine patches are not generally recommended to this groups since nicotine can affect fetal and neonatal brain development)

• Contraindication for nicotine patches. Absolute contraindications include: severe eczema or serious skin conditions, allergy to nicotine patches, pregnancy, breastfeeding, heart attack in the past 2 months, ongoing angina, peptic ulcer disease, arrhythmia, or uncontrolled blood pressure. Potential contraindications include: stroke in the past 6 months, insulin therapy, and a current diagnosis of liver, kidney, or heart disease. Study participants reporting a potential contraindication will require approval from their primary care provider and/or other treating physician (e.g., psychiatrist) to use nicotine patches. If the request is denied or not returned in 2 weeks, potential study participants will be excluded from the study.

• Current use of tobacco cessation medications

• Enrollment in another smoking cessation study

• Non-English speakers

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• SmokefreeSGM
Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers.
• SmokefreeTXT
Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed by number of participants recruited for the study		Baseline
Primary	Feasibility as assessed by number of participants that completed month 1 visit		end of month 1
Primary	Feasibility as assessed by number of participants that completed month 3 visit		end of month 3
Primary	Feasibility as assessed by number of participants that completed month 6 visit		end of month 6
Primary	Feasibility as assessed by number of participants that quit smoking		3 month follow up
Primary	Feasibility as assessed by number of participants that quit smoking		6 month follow up
Secondary	Acceptability as assessed by qualitative interviews		6 months follow up