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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05645354
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.7
• Patients Per Site Per Month: 6.8

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Behavioral: SmokefreeSGM; Behavioral: SmokefreeTXT	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: SmokefreeSGM, A Text-based Smoking Cessation Feasibility Trial for Sexual and Gender Minority Groups
• Actual Study Start Date: Nov 10, 2022
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SmokefreeSGM	Behavioral: SmokefreeSGM; Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers.
Active Comparator: SmokefreeTXT	Behavioral: SmokefreeTXT; Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population

Outcome Measures

Primary Outcome Measures

1. Feasibility as assessed by number of participants recruited for the study [Baseline]

2. Feasibility as assessed by number of participants that completed month 1 visit [end of month 1]

3. Feasibility as assessed by number of participants that completed month 3 visit [end of month 3]

4. Feasibility as assessed by number of participants that completed month 6 visit [end of month 6]

5. Feasibility as assessed by number of participants that quit smoking [3 month follow up]

6. Feasibility as assessed by number of participants that quit smoking [6 month follow up]

Secondary Outcome Measures

1. Acceptability as assessed by qualitative interviews [6 months follow up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Irene Tami-Maury, DMD,MSc,DrPH-NHSN, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Irene Tami-Maury, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT05645354
• Other Study ID Numbers: HSC-SPH-22-0717; K22CA237639
• First Posted: Dec 9, 2022
• Last Update Posted: Dec 9, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Irene Tami-Maury, Assistant Professor, The University of Texas Health Science Center, Houston: lesbian, gay, bisexual, transgender, queer (LGBTQ)

Study Results

No Results Posted as of Dec 9, 2022