Wellness Intervention for Smoking Cessation in HIV/AIDS

((WISH) Trial)

Recruiting at 1 trial location

Overseen By Gabriela Montenegro

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must be taking: Varenicline

Must not be taking: Sleep medications

Disqualifiers: Unstable mental illness, Unstable cardiac, others

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

Compensation: Varies

Number of Visits: 14

Duration: 13 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people living with HIV quit smoking by testing two different 13-week health approaches. Participants will take varenicline, a medication that reduces smoking cravings, and receive individual counseling sessions. Researchers seek to determine which approach is more effective at helping people quit smoking and improve sleep and heart health. The trial is recruiting adults who smoke at least five cigarettes a day, have HIV, and want to quit smoking soon. As an unphased trial, participants can contribute to valuable research that may enhance health strategies for those living with HIV.

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 must be on stable antiretroviral therapy without plans to change it. If you use sleep medications or other smoking cessation products, you may need to stop them.

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

Research has shown that varenicline, the medication used in this trial, is generally safe for people with HIV. Studies have found that it helps people quit smoking without affecting key HIV health indicators, such as CD4 cell count or viral load. However, varenicline can cause common side effects, leading some individuals to discontinue its use.

The two different health approaches tested in this trial lack specific safety data at this time. These are behavioral methods, which typically pose low risk. Safety checks are conducted throughout the trial to ensure participants' well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for smoking cessation in individuals with HIV/AIDS because they combine innovative behavioral health interventions with the medication Varenicline. Unlike traditional treatments that rely solely on medication or counseling, these approaches integrate personalized behavioral techniques administered by a clinical psychologist, which may enhance effectiveness. This holistic approach targets both the physical and psychological aspects of addiction, potentially offering more comprehensive support for individuals trying to quit smoking.

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

Research shows that Varenicline, one of the treatments in this trial, helps people quit smoking. In one study, 34.3% of people with HIV who took Varenicline quit smoking after 12 weeks, compared to only 12.6% who took a placebo. Other studies confirm that Varenicline increases the chances of quitting smoking in everyday life.

This trial will compare different health intervention approaches. Research suggests that adding personalized strategies to help people quit smoking as part of HIV care can improve success rates. These strategies include personalized counseling and support. Using these methods along with Varenicline further increases the chances of quitting smoking. ^{3 6 7 8 9}

Who Is on the Research Team?

Elizabeth Connick, MD

Principal Investigator

University of Arizona

Michael Grandner, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

Adults aged 18-75 living with HIV, smoking at least 5 cigarettes a day, and wanting to quit in the next month can join. They must be on stable HIV treatment or not planning to start it soon, have a CD4+ count ≥200 cells/mm3, and commit to attending sessions for 10 months. Pregnant women or those likely to become pregnant who won't use contraception are excluded.

Inclusion Criteria

Documented HIV infection

I can safely take varenicline tartrate.

CD4+ T cell count ≥ 200 cells/mm3

Exclusion Criteria

You have tried to harm yourself in the past two years or are currently having thoughts about hurting yourself.

I am able to complete all study tasks.

I have not had a seizure in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phone and in-person assessments

Treatment

Participants receive a 13-week personalized smoking cessation intervention with varenicline and counseling

13 weeks

8 in-person visits

Follow-up

Participants are monitored for smoking cessation, sleep metrics, and cardiovascular biomarkers

6 months

Follow-up assessments at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Health Approach 1 to Reduce Smoking
• Health Approach 2 to Reduce Smoking
• Smoking Cessation Counseling
• Varenicline

Trial Overview The trial is testing two different health approaches aimed at reducing smoking alongside varenicline medication and counseling sessions over 13 weeks. It will compare their effects on quitting smoking, improving sleep quality, and lowering cardiovascular risk in people with HIV.

How Is the Trial Designed?

Group I: Health Intervention Approach 1 Active Control 3 Interventions

Subjects randomized into Group 1 will be provided with approach 1, a behavioral health intervention administered by a Clinical Psychologist, in addition to administration of medication (Varenicline), and counseling, during 6 study visits.

Group II: Health Intervention Approach 2 Active Control 3 Interventions

Subjects randomized into Group 1 will be provided with approach 1, a behavioral health intervention administered by a Clinical Psychologist, in addition to administration of medication (Varenicline), and counseling, during 6 study visits.

Health Approach 1 to Reduce Smoking is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Champix for:

• Smoking cessation

Approved in United States as Chantix for:

• Smoking cessation

Approved in Canada as Champix for:

• Smoking cessation

Approved in Japan as Champix for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

University of Delaware

Collaborator

Trials

167

Recruited

25,700+

Published Research Related to This Trial

In a pilot study of 72 Black smokers, varenicline showed adequate adherence rates (86.1%) and led to a significant reduction in smoking (12.2 cigarettes per day), but only 23.6% achieved confirmed quit status at 3 months.

Higher adherence to varenicline was associated with successful quitting, suggesting that improving adherence to smoking cessation medications could enhance abstinence rates among Black smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot clinical trial of varenicline for smoking cessation in black smokers. Nollen, NL., Cox, LS., Nazir, N., et al.[2022]

In a study involving 248 people living with HIV, varenicline combined with counseling significantly increased the rate of smoking cessation compared to placebo, with 15% of participants in the varenicline group achieving continuous abstinence from weeks 9 to 48.

The safety profile of varenicline was favorable, showing a lower incidence of depression in the varenicline group (2%) compared to the placebo group (10%), indicating that varenicline is a safe and effective option for smoking cessation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of varenicline for smoking cessation in people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial. Mercié, P., Arsandaux, J., Katlama, C., et al.[2018]

In a clinical trial involving 179 people living with HIV/AIDS, varenicline significantly increased smoking cessation rates at Week 12 compared to placebo, with 28.1% of participants quitting versus 12.1%.

Varenicline was found to be safe, with no significant differences in treatment-related side effects or adverse events compared to placebo, making it a viable option for short-term smoking cessation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo-controlled randomized clinical trial testing the efficacy and safety of varenicline for smokers with HIV. Ashare, RL., Thompson, M., Serrano, K., et al.[2023]

In a study of 158 people living with HIV, combining varenicline with text message support and adherence-focused behavioral therapy significantly improved smoking abstinence rates compared to standard care alone after 12 weeks.

The research highlights the importance of intensive behavioral support in smoking cessation programs for people living with HIV, suggesting that enhancing adherence self-efficacy can lead to better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Text Messaging and Telephone Counseling to Increase Varenicline Adherence and Smoking Abstinence Among Cigarette Smokers Living with HIV: A Randomized Controlled Study. Tseng, TY., Krebs, P., Schoenthaler, A., et al.[2022]

In a study of 179 people living with HIV/AIDS, quitting smoking did not negatively impact adherence to anti-retroviral therapy (ART), which remained above 98% for all participants.

Participants who successfully quit smoking reported significant reductions in depression and anxiety symptoms, along with increased life satisfaction, suggesting that smoking cessation can have positive psychological effects for individuals with HIV/AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved clinical outcomes among persons with HIV who quit smoking. Lubitz, SF., Flitter, A., Ashare, RL., et al.[2021]

Smoking cessation is crucial for health, and psychiatric nurses should actively support patients in using therapies like varenicline (Chantix) to quit smoking.

Recent research has raised safety concerns about varenicline, including its potential links to neuropsychiatric side effects, seizures, and interactions with alcohol, which clinicians need to consider when recommending this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. Tobin, TJ., Tobin, ML.[2018]

In a pilot study involving 36 HIV-infected smokers, varenicline was found to be safe and effective for smoking cessation, with a 42% rate of verified continuous abstinence over 4 weeks.

The treatment did not adversely affect HIV viral load, and CD4 counts increased significantly, indicating that varenicline can be a viable option for smoking cessation in this population, despite common side effects like nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of varenicline tartrate (Champix(®)/Chantix(®)) for smoking cessation in HIV-infected subjects: a pilot open-label study. Cui, Q., Robinson, L., Elston, D., et al.[2021]

Participants who chose varenicline (3,116 individuals) for tobacco cessation had higher abstinence rates at both 3 months (22%) and 6 months (17%) compared to those using nicotine replacement therapy (NRT) (13% at 3 months and 11% at 6 months), indicating that varenicline may be more effective in supporting quitting.

The study found that factors such as increasing age, having health insurance, and the number of counseling sessions were associated with higher rates of abstinence, particularly at 3 months, suggesting that these factors could enhance the effectiveness of quitline services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. Biazzo, LL., Froshaug, DB., Harwell, TS., et al.[2015]

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]

Repackaging varenicline tartrate tablets into a dose administration aid, like Webster-pak®, is feasible and does not compromise the tablets' physical or chemical stability after 6 weeks of storage in humid conditions.

The study confirmed that the repackaged tablets maintained their drug content within the required range, supporting the idea that using dose administration aids can enhance adherence to smoking cessation medications without affecting their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing varenicline adherence through repackaging in a dose administration aid. Drovandi, AD., Robertson, SG., Malau-Aduli, BS., et al.[2022]

In a randomized controlled trial, varenicline (Chantix) demonstrated a higher abstinence rate from smoking after one year compared to both bupropion SR (Zyban) and a placebo, indicating its efficacy in treating tobacco dependence.

Despite its effectiveness, varenicline has been associated with serious neuropsychiatric side effects, highlighting the importance of discussing potential risks and benefits with patients considering this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of nicotine dependence with Chantix (varenicline). Rankin, KV., Jones, DL.[2015]

Citations

1. withpower.com withpower.com/trial/phase-cardiovascular-diseases-1-2021-ed7ff

Wellness Intervention for Smoking Cessation in HIV/AIDS Health Approach 1 to Reduce Smoking is already approved in European Union ... Improved clinical outcomes among persons with HIV who quit smoking. [2021].

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8607828/

Effectiveness of a Smoking Cessation Algorithm Integrated ... A smoking cessation pharmacotherapy recommendation algorithm integrated into HIV primary care may increase treatment utilization and smoking abstinence.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858725/

A Review of Smoking Cessation Interventions - PubMed Central This study highlights the efficacy of combination therapy as a potent strategy for enhancing smoking cessation outcomes.

4. evidence.nejm.org evidence.nejm.org/doi/full/10.1056/EVIDoa2400090

Efficacy of Smoking Cessation Interventions among People ... Both bupropion and PSF cessation counseling were effective in promoting abstinence from smoking at 36 weeks.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421002871

Effectiveness of a smoking cessation algorithm integrated ... A smoking cessation pharmacotherapy recommendation algorithm integrated into HIV primary care may increase treatment utilization and smoking abstinence.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04725617

NCT04725617 | Wellness Intervention for Smoking and HIV The investigators propose to use a parallel group, randomized controlled trial to test the efficacy of a 13-week personalized approach to reducing smoking ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8478961/

A SMART Approach to Treating Tobacco Use Disorder in ... The primary outcome is eCO-confirmed smoking abstinence; secondary outcomes include CD4 cell count, HIV viral load suppression, and the Veterans Aging Cohort ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772724623000392

Assessing access to smoking cessation services in ... This study documented methods and results of analyses to characterize current access to smoking cessation services in Southern California HIV safety nets and ...

9. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-01759

A Harm Reduction Approach for Improving Risk ... This clinical trial evaluates whether a “harm reduction” approach can result in significant decreases in the risk for the health harms of cigarette smoking ...