Smoking Cessation Intervention for HIV/AIDS

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen by Keith M Sigel

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates the usefulness of using a smartphone-based HIV-specific smoking cessation intervention at the time of lung cancer screening in helping people living with HIV quit smoking. Positively Smoke Free - Mobile may help patients with HIV quit smoking.

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 data supports the effectiveness of this treatment for smoking cessation in individuals with HIV/AIDS?

Episodic future thinking (EFT) has shown promising results in reducing cigarette demand among individuals with substance use disorders, which may be relevant for those with HIV/AIDS who also smoke. Additionally, smoking cessation is crucial for improving the health of individuals with HIV, as smoking-related health risks are significant in this population. ^{1 2 3 4 5}

Is episodic future thinking (EFT) safe for use in smoking cessation interventions?

Episodic future thinking (EFT) has been studied in various contexts, including smoking cessation and substance use disorders, and no significant safety concerns have been reported in these studies. It is generally considered safe for use in humans. ^{1 4 6 7 8}

How is the Smoking Cessation Intervention for HIV/AIDS different from other treatments?

This treatment is unique because it uses Episodic Future Thinking (EFT), which involves imagining future events to reduce smoking urges, and it is specifically tailored for people living with HIV/AIDS, addressing their unique stressors and health needs. ^{2 3 9 10 11}

Research Team

Keith M Sigel

Principal Investigator

AIDS Malignancy Consortium

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Nicotine Replacement (Nicotine Replacement)
• Smoking Cessation Intervention (Behavioural 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.

Participant Groups

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+

Dr. Joseph Sparano

AIDS Malignancy Consortium

Chief Executive Officer since 2015

MD from Albert Einstein College of Medicine

Dr. Marco Ruiz

AIDS Malignancy Consortium

Chief Medical Officer since 2021

MD from University of Miami

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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) 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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Episodic future thinking for smoking cessation in individuals with substance use disorder: Treatment feasibility and acceptability. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Human immunodeficiency virus infection, AIDS, and smoking cessation: the time is now. [2005]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Contingency management for smoking cessation among individuals with substance use disorders: In-treatment and post-treatment effects. [2021]

6. Switzerland 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Evaluating effects of episodic future thinking on valuation of delayed reward in cocaine use disorder: a pilot study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Reduced calibration between subjective and objective measures of episodic future thinking in alcohol use disorder. [2022]

9. England 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

Smoking-cessation interventions in people living with HIV infection: a systematic review. [2022]