400 Participants NeededMy employer runs this trial

Empowerment-Based Intervention for Smoking Cessation

(CHERC Trial)

JM
DB
JM
LR
Overseen ByLaur Rubino
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: University of Oklahoma
Must be taking: Nicotine replacement
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help sexual and/or gender minority (SGM) individuals quit smoking, particularly those in areas with high stigma against SGM communities. The trial tests an empowerment-based approach called Empowering Cessation for the ACS South, which combines smoking cessation support with volunteering activities tailored for the SGM community. Participants will be divided into two groups: one receiving both smoking cessation tools and volunteering opportunities, and the other receiving only the smoking cessation tools. Ideal candidates are SGM-identifying individuals living in Oklahoma, Texas, or Arkansas, who currently smoke and are eager to quit within the next 30 days. As a Phase 2, Phase 3 trial, this study evaluates the treatment's effectiveness and represents the final step before FDA approval, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be using other smoking cessation treatments while participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that using nicotine replacement therapy (NRT), such as patches or gum, along with habit-changing support, is generally safe and well-tolerated for quitting smoking. Participants in other research reported few serious side effects from NRT. Combining these aids with non-drug support appears to enhance success in quitting smoking without major safety concerns.

For the study's volunteering component, specific safety data is not yet available. However, similar programs that combine activities with smoking cessation have not reported major issues. The trial's advanced stage suggests that earlier studies found the treatment to be acceptably safe.

Both groups in this trial will use the National Cancer Institute's smoking cessation app and NRT, which existing research has shown to be safe.12345

Why are researchers excited about this trial?

Researchers are excited about this smoking cessation intervention because it combines traditional nicotine replacement therapy (NRT) with a unique digital and community engagement approach. Unlike standard treatments that primarily focus on nicotine replacement through lozenges, gum, or patches, this intervention leverages a smoking cessation app and incorporates online volunteering activities specifically designed for sexual and gender minority communities. This innovative blend aims to enhance support networks and foster a sense of empowerment, potentially leading to more effective and sustained quitting outcomes.

What evidence suggests that this trial's treatments could be effective for smoking cessation in SGM people?

Studies have shown that combining support to quit smoking with nicotine replacement products can significantly increase the chances of quitting. Specifically, participants who completed the program achieved quit rates of up to 33% in the short term and 28% in the long term. In this trial, one group will receive smoking cessation support combined with volunteering activities, which research suggests can boost motivation and confidence—key factors for quitting smoking. Another group will receive only smoking cessation support. Apps designed to assist in quitting can also enhance engagement and commitment to the process. Together, these elements aim to make the Empowering Cessation program as effective as possible.24678

Who Is on the Research Team?

JM

Julia McQuoid, PhD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for adults who identify as sexual and/or gender minorities (SGM) living in Oklahoma, Arkansas, or Texas. Participants should currently smoke and want to quit. The study focuses on people in areas with high stigma against SGM individuals.

Inclusion Criteria

I am 18 years old or older.
I identify as a sexual and/or gender minority.
Living in Oklahoma, Texas, or Arkansas (verified by address)
See 6 more

Exclusion Criteria

Currently using other smoking cessation treatments
I cannot or do not want to use nicotine replacement therapy.
Serious psychological distress (i.e., score of 13 ≥ 18 on the Kessler Psychological Distress (PD) Scale-6 19)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remotely-delivered smoking cessation support using the NCI's app and NRT, with additional online volunteer activities for the experimental group

12 weeks
Remote interactions via phone/text, email, web-based platforms, and video chat

Follow-up

Participants are monitored for smoking cessation and other outcomes post-treatment

14 weeks
Remote follow-up at 26 weeks post-quit-date

What Are the Treatments Tested in This Trial?

Interventions

  • Empowering Cessation for the ACS South

Trial Overview

The trial is testing a remotely-delivered smoking cessation program designed specifically for SGM adults. It uses empowerment-based support and community engagement to help participants quit smoking.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Smoking cessation support + volunteeringExperimental Treatment1 Intervention
Group II: Smoking cessation support ONLYActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Citations

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