Smoking Cessation Intervention for HIV/AIDS

Recruiting at 14 trial locations

Overseen By Edwin Ostrin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AIDS Malignancy Consortium

Must be taking: Antiretrovirals

Must not be taking: Smoking cessation drugs

Disqualifiers: Lung cancer, Pregnancy, Serious lung infection, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with HIV quit smoking through a smartphone app and nicotine patches or gum. The app, Positively Smoke Free - Mobile, supports quitting efforts, particularly during lung cancer screenings. It suits people living with HIV who smoke and own a smartphone. Participants should have a long history of smoking and be prepared to use the app and nicotine replacement therapy (NRT). As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance smoking cessation strategies for people with HIV.

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

The trial does not specify if you need to stop taking your current medications, but it does require that you are already receiving antiretroviral therapy for HIV. You cannot be receiving any other smoking cessation interventions currently or within the prior 30 days.

What prior data suggests that this smoking cessation intervention is safe for people living with HIV?

Research has shown that nicotine replacement therapy (NRT) is generally safe and aids in quitting smoking by reducing cravings and withdrawal symptoms. NRT products contain pure nicotine, which is safer than smoking tobacco, and no major safety concerns have been reported with NRT.

Studies have also found that using a smartphone app to assist in quitting smoking is safe, with no significant safety issues associated with this intervention.

Overall, both NRT and the smartphone app are well-tolerated and have no major safety problems reported, making them safe options for those looking to quit smoking, including individuals living with HIV. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this smoking cessation intervention for individuals with HIV/AIDS because it integrates technology and personalized support in a unique way. Unlike traditional programs that rely solely on counseling or nicotine replacement, this approach includes a smartphone app, Positively Smoke Free - Mobile, which provides tailored support and motivation for 42 days. Additionally, it combines nicotine replacement therapy for 12 weeks and includes low-dose computed tomography (LDCT) within 60 days to monitor lung health, offering a comprehensive strategy that addresses both addiction and the specific health needs of people with HIV/AIDS. This multifaceted approach not only aims to help individuals quit smoking but also detects potential lung issues early, making it a promising development in smoking cessation for this population.

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

Research has shown that nicotine replacement therapy (NRT), one of the treatments in this trial, can double the chances of quitting smoking. NRT helps control cravings by mimicking the effect of nicotine from cigarettes. Participants in this trial will also engage in a smoking cessation intervention that includes episodic future thinking (EFT). Studies indicate that EFT, especially when combined with cognitive-behavioral therapy, effectively reduces smoking, decreasing nicotine use by over 69%. Together, these methods offer promising ways to help people stop smoking. ^{1 5 6 7 8}

Who Is on the Research Team?

Keith M Sigel

Principal Investigator

AIDS Malignancy Consortium

Are You a Good Fit for This Trial?

This trial is for HIV-positive adults aged 45-80 who smoke and meet criteria for lung cancer screening. They must understand the study, consent to participate, have a compatible smartphone, and not be pregnant or breastfeeding. Exclusions include recent CT scans, history of lung cancer, serious infections, or other health issues that could affect participation.

Inclusion Criteria

I am on HIV medication and my CD4 count is at least 200.

I own a smartphone compatible with the PSF-M app.

I am between 45 and 80 years old.

Exclusion Criteria

I have not had pneumonia or a serious lung infection in the last 3 months.

Pregnant women are excluded from this study because computed tomography introduces radiation exposure and may have teratogenic effects

I cannot use nicotine replacement therapy due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the smartphone application, Positively Smoke Free - Mobile, for 42 days and receive nicotine replacement therapy for 12 weeks. Within 60 days of study registration, patients undergo LDCT.

12 weeks

Follow-up

Participants are monitored for smoking cessation and adherence to interventions at 3, 6, and 12 months.

12 months

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine Replacement
• Smoking Cessation Intervention

Trial Overview The trial tests if a smartphone-based smoking cessation program can help people with HIV quit smoking when combined with lung cancer screening using low-dose computed tomography (LDCT). The goal is to see if this approach is feasible and effective in promoting smoking cessation.

How Is the Trial Designed?

Group I: Prevention (smoking cessation, nicotine replacement, LDCT) Experimental Treatment 2 Interventions

Patients use the smartphone application, Positively Smoke Free - Mobile, for 42 days. Patients also receive nicotine replacement therapy for 12 weeks. Within 60 days of study registration, patients undergo LDCT.

Who Is Running the Clinical Trial?

AIDS Malignancy Consortium

Lead Sponsor

Trials

64

Recruited

9,600+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Smoking cessation interventions for people living with HIV (PLWH) are effective, particularly those using cell phone technology, which showed a high likelihood of success with odds ratios between 4.33 and 5.6.

Successful smoking cessation in PLWH led to clinically significant health improvements, including reductions in systolic blood pressure, weight gain, and increased CD(4+) T-cell counts, highlighting the importance of tailored interventions that address individual needs and co-occurring issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking-cessation interventions in people living with HIV infection: a systematic review. Moscou-Jackson, G., Commodore-Mensah, Y., Farley, J., et al.[2022]

Combination antiretroviral therapy has transformed HIV from a terminal illness into a manageable chronic disease, significantly improving the life expectancy and quality of life for those infected.

Cigarette smoking is common among HIV-infected individuals, and tailored smoking-cessation interventions could greatly enhance their health, yet no specific studies have been conducted to evaluate the effectiveness of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human immunodeficiency virus infection, AIDS, and smoking cessation: the time is now. Niaura, R., Shadel, WG., Morrow, K., et al.[2005]

A pilot randomized controlled trial involving 25 participants compared a tailored smoking cessation intervention to standard care, finding that while quit rates were not significantly different, the tailored intervention led to a greater reduction in cigarettes smoked per day (13.5 vs. 0.0).

Both groups showed improvements in self-efficacy and reductions in exhaled carbon monoxide, indicating that the tailored intervention may be beneficial for supporting smoking cessation among people living with HIV, warranting further research with a larger sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of a tailored smoking cessation program for people living with HIV in the Washington, D.C. metropolitan area. Kierstead, EC., Harvey, E., Sanchez, D., et al.[2023]

Episodic future thinking (EFT) was successfully applied in a pilot study with 18 individuals seeking treatment for cocaine use disorder, showing that it can help reduce impulsive decision-making by decreasing the discounting of future rewards.

Participants who engaged in EFT by envisioning future positive events demonstrated a significant reduction in discounting behavior compared to standard conditions, indicating that EFT may have therapeutic potential for improving future-oriented decision-making in substance use recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating effects of episodic future thinking on valuation of delayed reward in cocaine use disorder: a pilot study. Forster, SE., Steinhauer, SR., Ortiz, A., et al.[2022]

Cigarette smoking is alarmingly common among people living with HIV, affecting 40-75% of this population, which leads to significant health risks including increased mortality and various diseases.

Despite many smokers with HIV wanting to quit and attempting to do so, there is a lack of effective smoking cessation interventions specifically designed for them, highlighting the need for more tailored treatment options and support from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco Use, Use Disorders, and Smoking Cessation Interventions in Persons Living With HIV. Pacek, LR., Cioe, PA.[2019]

Patients with severe alcohol use disorder (AUD) generated fewer detailed future scenarios compared to healthy controls, indicating a significant impairment in their ability to mentally simulate future events, even when accounting for cognitive functioning.

Despite producing less detailed future scenarios, individuals with AUD rated their imagined events similarly to healthy participants, suggesting a distortion in their self-assessment abilities regarding the richness of their future imaginings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced calibration between subjective and objective measures of episodic future thinking in alcohol use disorder. Noël, X., Saeremans, M., Kornreich, C., et al.[2022]

The combination of cognitive-behavioral treatment (CBT) and episodic future thinking (EFT) for smoking cessation in a group of 29 smokers with substance use disorders was found to be acceptable, with a high satisfaction rating of 8.83 out of 10.

Despite the positive reception, adherence to the EFT component was low, with only 15.8% of participants practicing it as recommended, indicating a need for adjustments in future studies to enhance compliance and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Episodic future thinking for smoking cessation in individuals with substance use disorder: Treatment feasibility and acceptability. Aonso-Diego, G., González-Roz, A., Martínez-Loredo, V., et al.[2021]

Episodic future thinking (EFT) significantly reduces delay discounting and cigarette craving among smokers, suggesting it may help in smoking cessation efforts.

Imagining smoking-related illness (SRI) increased delay discounting but also reduced craving, indicating that while SRI can heighten the perceived value of immediate rewards, it may also help in managing cravings when combined with EFT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Episodic Future Thinking about Smoking-Related Illness: A Preliminary Investigation of Effects on Delay Discounting, Cigarette Craving, and Cigarette Demand. Ruhi-Williams, P., King, MJ., Stein, JS., et al.[2022]

Cigarette smoking is significantly more common among HIV-infected adults (50-70%) compared to the general population, and many express a desire to quit, indicating a need for targeted cessation interventions.

Smoking cessation rates in HIV-infected adults vary widely (6%-50%) across studies, with emotional distress and declining adherence to treatment being major barriers; however, combining nicotine replacement therapy with intensive counseling via cell phones shows promise for improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation Interventions in HIV-Infected Adults in North America: A Literature Review. Cioe, PA.[2021]

The addition of contingency management (CM) to cognitive behavioral treatment (CBT) with episodic future thinking (EFT) significantly increased 24-hour tobacco abstinence rates from 20% to 50% among 54 treatment-seeking participants, indicating a more effective approach for smoking cessation.

While not statistically significant, the CM group showed improved in-treatment behaviors such as higher retention rates and more sessions attended, suggesting that CM may enhance overall treatment engagement and adherence to nicotine reduction guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management for smoking cessation among individuals with substance use disorders: In-treatment and post-treatment effects. Aonso-Diego, G., González-Roz, A., Krotter, A., et al.[2021]

Episodic future thinking (EFT) shows promise as an intervention for reducing problematic substance use and substance use disorders, based on a systematic review of 16 studies that demonstrated benefits in self-reported and task-based outcomes.

The review highlights the need for further research to assess the feasibility, generalizability, and long-term effects of EFT, as well as to identify factors that influence its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imagining the future can shape the present: A systematic review of the impact of episodic future thinking on substance use outcomes. Collado, A., Stokes, A.[2023]

Citations

1. 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.

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

Nicotine Replacement Therapy to Help You Quit Tobacco Nicotine replacement therapy (NRT) can help with cravings and physical withdrawal symptoms from quitting smoking and other tobacco products.

3. mayoclinic.org mayoclinic.org/diseases-conditions/nicotine-dependence/in-depth/quit-smoking-products/art-20045599

Quit-smoking products: Boost your chance of success Using quit-smoking products can greatly boost your chance of success. They may more than double your odds of quitting smoked tobacco.

4. fda.gov fda.gov/consumers/consumer-updates/want-quit-smoking-fda-approved-and-fda-cleared-cessation-products-can-help

Want to Quit Smoking? FDA-Approved Cessation Products ... Smoking cessation products approved or cleared by the FDA are shown to help people quit smoking and can even double your chance of quitting ...

5. aap.org aap.org/en/patient-care/tobacco-control-and-prevention/youth-tobacco-cessation/nicotine-replacement-therapy-and-adolescent-patients/?srsltid=AfmBOooWnQJyZNHIcvTA0bG-kaXx40JMMn5s-8Y-1RnPg2l1KTl1AXXt

Nicotine Replacement Therapy and Adolescent Patients NRT is safe and effective in helping adults quit tobacco use, according to the CDC. NRT works best when paired with behavioral counseling ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7491776/

Nicotine replacement therapy: A friend or foe - PMC Nicotine replacement products (NRPs) contain pure nicotine with an aim to reduce the patient's inclination towards tobacco consumption.

7. fda.gov fda.gov/media/167599/download

Developing Nicotine Replacement Therapy Drug Products both a chewing gum and a mouth spray are oral-transmucosal products, but the nicotine delivery ... administration must contain data that are adequate to assess ...

8. aap.org aap.org/en/patient-care/tobacco-control-and-prevention/youth-tobacco-cessation/nicotine-replacement-therapy-and-adolescent-patients/?srsltid=AfmBOood-Q6freIPGVeLSXFByZyq3nvuPHq_CuCUbt_mDZjzOw37dT8r

Nicotine Replacement Therapy and Adolescent Patients This page is intended to help pediatricians make informed decisions about using NRT with patients who wish to quit smoking or vaping.