Smoking Cessation Intervention for HIV/AIDS
Recruiting in Palo Alto (17 mi)
+10 other locations
KM
Overseen byKeith 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.12345
Is episodic future thinking (EFT) safe for use in smoking cessation interventions?
How is the Smoking Cessation Intervention for HIV/AIDS different from other treatments?
Research Team
KM
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.
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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.
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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 OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Prevention (smoking cessation, nicotine replacement, LDCT)Experimental Treatment2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UC San Diego Moores Cancer CenterLa Jolla, CA
Weill Cornell Medicine - Cornell Clinical Trials UnitNew York, NY
Thomas Jefferson UniversityPhiladelphia, PA
George Washington UniversityDistrict of columbia, United States
More Trial Locations
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Who Is Running the Clinical Trial?
AIDS Malignancy Consortium
Lead Sponsor
Trials
64
Patients Recruited
9,600+
National Cancer Institute (NCI)
Collaborator
Trials
14080
Patients Recruited
41,180,000+
References
Episodic future thinking for smoking cessation in individuals with substance use disorder: Treatment feasibility and acceptability. [2021]Smokers with substance use disorders (SUD) smoke approximately four times more than the general population. Current efforts are focused on improving smoking cessation treatments for this population. Episodic future thinking (EFT), a novel intervention aimed at decreasing impulsive choice, has shown promising results for reducing cigarette demand in experimental settings. This feasibility study sought to examine the feasibility and preliminary EFT effects on delay discounting (DD) and nicotine intake reductions throughout treatment.
Human immunodeficiency virus infection, AIDS, and smoking cessation: the time is now. [2005]Treatments for persons who are infected with human immunodeficiency virus (HIV) or who have developed AIDS have advanced to the point where death is no longer the inevitable outcome of diagnosis. Combination antiretroviral therapy has made HIV infection less of a terminal condition and more of a medically manageable chronic disease. Thus, efforts to improve the health status and quality of life of HIV-infected persons have become one of the highest treatment priorities for the next decade. Cigarette smoking is highly prevalent among HIV-infected persons, and quitting smoking would greatly improve the health status of these individuals. However, to date, no studies have evaluated the efficacy of a smoking-cessation intervention specifically tailored to this population. This article reviews the evidence and rationale for advancing smoking-cessation treatments specifically tailored to the needs of HIV-infected persons and provides recommendations for future treatment studies.
Tobacco Use, Use Disorders, and Smoking Cessation Interventions in Persons Living With HIV. [2019]Cigarette smoking remains highly prevalent among persons living with human immunodeficiency virus (HIV), estimated to be 40-75 %, and is significantly higher than what is observed among the general population. Health risks of smoking in this population include cardiovascular disease; bacterial pneumonia, chronic obstructive pulmonary disease, and other respiratory conditions; lung cancer and other malignancies; adverse cognitive and neurological outcomes; low birth weight, preterm birth, and small-for-gestational-age infants; and overall mortality. Smokers with HIV now lose more life years to smoking than they do to the HIV itself. A majority of smokers living with HIV report being interested in cessation, and a significant proportion has made recent quit attempts. There is a general paucity of large, randomized controlled trials of smoking cessation interventions among smokers living with HIV, and among the existing research, cessation rates are suboptimal. Greater resources and effort should be allocated to developing and evaluating cessation treatment modalities for smokers living with HIV. Efforts to individualize and tailor treatments to address specific client needs and comorbidities are warranted. HIV care providers and other health professionals can play a key role in improving health among this population by regularly screening for smoking and promoting cessation.
Imagining the future can shape the present: A systematic review of the impact of episodic future thinking on substance use outcomes. [2023]The combination of the high prevalence of problematic substance use and substance use disorders (SUD) with the low rates of spontaneous remission continues to generate interest in the development of novel and efficacious interventions. Theoretically, episodic future thinking (EFT) is capable of targeting various underlying psychological and neurobiological substrates of SUD by traversing various research domain criteria systems.
Contingency management for smoking cessation among individuals with substance use disorders: In-treatment and post-treatment effects. [2021]Smokers with substance use disorders (SUDs) show elevated tobacco prevalence, and smoking abstinence rates are considerably low. This randomized controlled trial sought to compare the effect of a cognitive behavioral treatment (CBT) that includes an episodic future thinking (EFT) component with the same treatment protocol plus contingency management (CM). This study aims to examine the effect of CM on smoking outcomes and in-treatment behaviors (i.e., retention, session attendance and adherence to nicotine use reduction guidelines), and to analyze whether these in-treatment variables predicted days of continuous abstinence at end-of-treatment.
Episodic Future Thinking about Smoking-Related Illness: A Preliminary Investigation of Effects on Delay Discounting, Cigarette Craving, and Cigarette Demand. [2022]Cigarette smokers show excessive delay discounting (devaluation of delayed rewards), which may contribute to tobacco use disorder. Episodic future thinking (EFT), or mental simulation of future events, has been shown to reduce both delay discounting and laboratory smoking behavior. Traditionally, EFT involves vividly imagining positive future events. In this preliminary investigation, we examined the effects of EFT specifically about smoking-related illness (SRI) on delay discounting, cigarette craving, and behavioral economic demand for cigarettes. In a 2 (episodic thinking) × 2 (smoking-related illness) factorial design, we randomly assigned smokers from Amazon Mechanical Turk to one of two EFT groups: EFT alone or EFT + SRI; or one of two episodic "recent" thinking (ERT) control groups: ERT alone or ERT + SRI. Both EFT groups generated and imagined positive future events, while both ERT groups imagined real events from the recent past. Both EFT + SRI and ERT + SRI groups imagined these events while also experiencing SRI symptoms. Participants then completed assessments of delay discounting, cigarette craving, and measures of cigarette demand. We observed significant main effects on delay discounting of both EFT (reduced discounting) and SRI (increased discounting), as well as significant main effects of both EFT and SRI on cigarette craving (in both cases, reduced craving). No significant main effect of EFT was observed on cigarette demand measures, although we observed a main effect of SRI on quantity of demand when cigarettes were free (Q0) (reduced demand). In all analyses, we observed no significant EFT × SRT interactions, indicating that these variables operate independently of one another. These methods may be adapted for use in clinical treatment to aid in smoking cessation interventions.
Evaluating effects of episodic future thinking on valuation of delayed reward in cocaine use disorder: a pilot study. [2022]Background: Episodic future thinking (EFT; i.e., envisioning oneself in future contexts) has been demonstrated to reduce discounting of future reward in healthy adults. While this approach has the potential to support future-oriented decision-making in substance use recovery, the impact of EFT on discounting behavior in illicit stimulant users has not yet been evaluated.Objectives: This pilot study aimed to (1) assess the feasibility of utilizing EFT methods in individuals with cocaine use disorder (CUD) and (2) conduct preliminary measurement of the EFT effect on discounting behavior in this population.Methods: Eighteen treatment-seeking individuals with CUD (17 males) were interviewed about positive and neutral events expected to occur at a range of future latencies. Future event information identified by participants was subsequently included on a subset of trials in an intertemporal choice task to promote EFT; within-subject differences in discounting between standard and EFT conditions were evaluated.Results: Participants identified relevant events and demonstrated decreased discounting of future reward when event descriptors were included (relative to discounting without event descriptors; p = .039). It was further noted that most events identified by participants were goals, rather than plans or significant dates.Conclusion: While methods previously used to study the effect of EFT on discounting behavior in healthy individuals are also effective in individuals with CUD, methodological factors - including types of events identified - should be carefully considered in future work. These preliminary findings suggest that EFT can reduce impulsive decision-making in cocaine use disorder and may therefore have therapeutic value.
Reduced calibration between subjective and objective measures of episodic future thinking in alcohol use disorder. [2022]A reduced capacity to mentally simulate future scenarios could be of clinical importance in alcohol use disorder (AUD). However, little is known about the mechanisms underlying episodic future thinking (EFT) impairment in AUD.
A pilot randomized controlled trial of a tailored smoking cessation program for people living with HIV in the Washington, D.C. metropolitan area. [2023]Morbidity and mortality from smoking-related diseases among people living with HIV (PLWH) in the U.S. surpasses that due to HIV itself. Conventional smoking cessation treatments have not demonstrated strong efficacy among PLWH. We conducted a pilot randomized controlled trial (RCT) to evaluate a tailored smoking cessation intervention based on the minority stress model. We compared standard of care counseling (SOC) to a tailored intervention (TI) including one face-to-face counseling session incorporating cognitive behavioral therapy to build resilience, and 30 days of 2-way text messaging.
Smoking Cessation Interventions in HIV-Infected Adults in North America: A Literature Review. [2021]Cigarette smoking is more prevalent in HIV-infected adults when compared to the general population (50-70%) and is linked to increased morbidity and mortality in this population. Of important clinical relevance, however, 40% of HIV-infected smokers express a willingness to attempt smoking cessation and two-thirds are interested in or considering quitting when asked. The purpose of this paper is to provide a state of the science review of the extant literature on smoking cessation interventions in HIV-infected adults. A comprehensive search of a computerized database for articles appearing in peer-reviewed journals was conducted. The integrative review included 10 articles from medical and nursing journals. Smoking cessation rates ranged from 6%-50% across studies employing pharmacologic and behavioral approaches. Samples sizes were frequently small and the effect was often not sustained over time. Emotional distress was related to smoking behaviors and may have been a barrier to successful smoking cessation. Adherence to pharmacologic therapy often declined over time and may have contributed to low cessation rates. Nicotine replacement therapy combined with a cell phone-delivered intensive counseling intervention showed promising results. Given the high prevalence of smoking among adults infected with HIV, this review supports the need for the development and implementation of innovative and effective interventions tailored to this population that will ultimately result in lower smoking prevalence and improved overall health.
Smoking-cessation interventions in people living with HIV infection: a systematic review. [2022]Tobacco smoking remains a prevalent behavior in people living with HIV infection (PLWHs) and is associated with impaired immune functioning, increased cardiovascular risk, and decreased response to antiretroviral therapy. This review presents a critique and synthesis of evidence on effective smoking-cessation interventions for PLWHs. A comprehensive search identified nine peer-reviewed intervention studies published between 1989 and 2012. The highest likelihood of smoking cessation (range of odds ratios 4.33-5.6) were in two randomized controlled trial interventions using cell phone technology. Clinically significant reductions in systolic blood pressure, weight gain, and increased CD(4+) T-cell count were reported in participants who ceased smoking in three of the nine studies. Overall, multistrategy smoking-cessation interventions, delivered over multiple sessions, were effective. However, the most effective interventions were tailored to the unique individual needs of PLWHs, including assessment of and intervention for polysubstance abuse and mental health issues, as well as the inclusion of access-promoting elements.