Nicotine Replacement Therapy + Wellness Coaching for Smoking Addiction

(EXIT Trial)

Overseen By Jessica Alway

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Disqualifiers: Pregnancy, Recent myocardial infarction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help people experiencing homelessness in California quit smoking. It tests a combination of nicotine replacement therapy (such as patches or gum) and wellness coaching to determine its effectiveness in reducing tobacco use. Participants are divided into two groups: one receives both nicotine therapy and coaching, while the other receives only nicotine therapy. The trial seeks participants who smoke at least five cigarettes a day and wish to quit within the next six months. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What is the safety track record for Nicotine Replacement Therapy and Wellness Coaching?

Past studies have shown that nicotine replacement therapy (NRT) safely helps people quit smoking by reducing cravings and withdrawal symptoms. Research indicates that NRT is generally well-tolerated, with few serious side effects. Some individuals might experience minor issues like skin irritation from patches or mouth irritation from gum or lozenges, but these are usually not severe.

Regarding the wellness coaching component, studies have found it effective in aiding smoking cessation, with no major safety concerns reported. Overall, both NRT and wellness coaching are considered safe options for those seeking to quit smoking. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they combine Nicotine Replacement Therapy (NRT) with personalized wellness coaching, which is quite different from the standard approach of using just NRT or counseling alone. The unique aspect here is the extended intervention model that integrates health coach-delivered telephone sessions targeting not only tobacco use but also addressing related psychiatric and substance-use issues. This comprehensive support system aims to tackle multiple aspects of a smoker's life, potentially leading to more successful and sustained smoking cessation. Additionally, the ongoing delivery of NRT alongside this coaching offers continuous support, which can enhance adherence and improve outcomes compared to typical short-term interventions.

What evidence suggests that this trial's treatments could be effective for smoking addiction?

Research shows that Nicotine Replacement Therapy (NRT) combined with wellness coaching can help people quit smoking. In this trial, one group of participants will receive both NRT and wellness coaching, which studies have found makes quitting easier. Another group will receive only NRT. For people who are homeless, a program with community pharmacists helped them smoke less and attempt to quit more frequently. Combining coaching with NRT also increased the likelihood of remaining smoke-free. Overall, this approach has shown promise in helping people quit smoking for good. ^{6 7 8 9 10}

Who Is on the Research Team?

Maya Vijayaraghavan, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals experiencing homelessness in San Francisco or Los Angeles who use tobacco products and are interested in quitting. Specific eligibility details are not provided, but typically include being of legal age to consent and having a desire to quit tobacco.

Inclusion Criteria

Ability of individual to understand a written informed consent document, and the willingness to sign it

I am 18 years old or older.

I understand and can follow the study's procedures.

Exclusion Criteria

Contraindication to any study-related procedure or assessment

I cannot use nicotine replacement therapy due to specific health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tobacco treatment with nicotine replacement therapy (NRT) and coaching for up to 6 months

6 months

Weekly-to-monthly wellness-focused telephone coaching

Follow-up

Participants are monitored for tobacco abstinence and provide CO samples for biochemical verification

6 months

Follow-up at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine Replacement Therapy
• Wellness Coaching

Trial Overview The study is testing the effectiveness of Nicotine Replacement Therapy (NRT) combined with Wellness Coaching to help participants quit using tobacco. It aims to understand how these interventions can support tobacco cessation among the homeless population.

How Is the Trial Designed?

Group I: Treatment (extended intervention for tobacco use) Experimental Treatment 2 Interventions

Participants receive pharmacist provided one-time tobacco treatment using the five As: Ask, Advise, Assess, Assist and Arrange (5As) model and receives an initial monthly delivery of nicotine replacement therapy (NRT) for 3 months. Participants then receive the extended intervention for tobacco use (EXIT) that consists of: 1) health coach-delivered, weekly-to-monthly wellness-focused telephone coaching for 6 months addressing tobacco use within the context of co-occurring psychiatric and substance-use comorbidities and other life stressors, and 2) an additional session of pharmacist-delivered 5As with monthly delivery of NRT for an additional 6 months. Participants will provide CO samples for biochemical verification of smoking abstinence and complete questionnaires throughout the study.

Group II: Pharm-only Experimental Treatment 1 Intervention

Participants receive pharmacist provided one-time tobacco treatment using the 5As and receive monthly delivery of NRT for 3 months. Participants will provide CO samples for biochemical verification of smoking abstinence and complete questionnaires throughout the study.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Tobacco Related Disease Research Program

Collaborator

Trials

27

Recruited

26,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10049574/

Effectiveness of Health Coaching in Smoking Cessation ... This study looked into the effectiveness of a 6 month health coaching intervention in smoking cessation and smoking reduction for patients with type 2 diabetes.

2. mhealth.jmir.org mhealth.jmir.org/2022/11/e41658

Outcomes of a Comprehensive Mobile Smoking Cessation ... This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide.

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/08901171241302926

Health and Wellness Coaching Can Improve Tobacco Quit ... Smoking cessation rates, even with outside resources, such as NRT and behavioral therapy, remain low, ranging from 4-57%, according to the CDC.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0376871624014522

Tobacco cessation, mental health, and substance use in a ... A community pharmacist-linked cessation program in homeless shelters was associated with reduced consumption and increased weekly quit attempts.

5. academic.oup.com academic.oup.com/ntr/article/24/11/1763/6574261

Long-Term Effectiveness of a Clinician-Assisted Digital ... Those in the treatment arm were 55% more likely to self-report 7-day abstinence at 4 weeks post-QD compared with those in the control group ( ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK493148/

Nicotine Replacement Therapy - StatPearls - NCBI Bookshelf NRTs are designed to replicate the nicotine response typically experienced through smoking, thereby helping individuals manage cravings and withdrawal symptoms.

7. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/Adverse-events-associated-with-nicotine-replacement-therapy-NRT-for-smoking-cessation,65973,0,2.html

Adverse events associated with nicotine replacement ... Nicotine replacement therapy (NRT) is the most common form of smoking cessation pharmacotherapy and has proven efficacy for the treatment of tobacco dependence.

8. cancer.org cancer.org/cancer/risk-prevention/tobacco/guide-quitting-smoking/nicotine-replacement-therapy.html

Nicotine Replacement Therapy to Help You Quit Tobacco Many studies have shown using NRT can almost double the chances of quitting smoking. It hasn't been studied as much for quitting smokeless ...

9. camh.ca camh.ca/en/professionals/treating-conditions-and-disorders/smoking-cessation/smoking-cessation---treatment/smoking-cessation---overview-of-nicotine-replacement-therapy

Smoking Cessation: Overview of Nicotine Replacement ... Using NRT maintains physical dependence on nicotine, but it is not associated with adverse health effects such as seen with smoking.

10. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1525510/full

Nicotine replacement therapy as a smoking cessation tool ... Although nicotine replacement has been shown to be safe for short-term use in adolescents, it is not currently recommended as a component of ...