Wellness Intervention for Smoking Cessation in HIV/AIDS

((WISH) Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Michael Grandner, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Arizona

Must be taking: Varenicline

Must not be taking: Sleep medications

Disqualifiers: Unstable mental illness, Unstable cardiac, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators propose to use a parallel group, randomized controlled trial to test the efficacy of a 13-week personalized approach to reducing smoking intervention versus a second approach using a different health intervention on smoking cessation, healthy sleep metrics, and biomarkers of cardiovascular risk in a sample of 200 treatment-seeking smokers who are adults living with HIV (ALHIV). To enroll in the study, treatment-seeking ALHIV smokers will undergo phone and in-person study eligibility assessments, including a history, physical examination, screening laboratory tests, and an overnight in-home objective sleep assessment. Eligible subjects (N=200) will be randomized to the 13-week Approach 1 (N=100) or Approach 2 (N=100) condition. All subjects will receive a 12-week course of varenicline (beginning in week 2) and 8 individual 15-minute smoking cessation counseling sessions \[weeks 1, 2, 3 (target quit date), 5, 7, 9, 11, 13\]. At each in-person counseling session, 30-45 minutes of Approach 1 or Approach 2 counseling will be provided as well. While receiving varenicline, the study team will monitor for side effects and changes to blood pressure at each study visit for safety reasons. Study measures are collected at all time points including EOT (week 13), and 6-month follow-up (6MFU).

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.

What data supports the effectiveness of the drug Varenicline (Chantix) for smoking cessation in people living with HIV/AIDS?

Research shows that people living with HIV who quit smoking using Varenicline (Chantix) did not experience negative effects on their HIV treatment adherence and reported reduced depression and anxiety, along with increased life satisfaction. Additionally, combining Varenicline with behavioral support like text messaging and counseling improved smoking abstinence rates. ^{1 2 3 4 5}

Is varenicline safe for smoking cessation in people with HIV?

Varenicline (also known as Champix or Chantix) has been studied for smoking cessation in people with HIV and is generally considered safe, though common side effects include nausea, abnormal dreams, and insomnia. There are additional safety concerns about potential neuropsychiatric side effects, so close monitoring is recommended. ^{2 6 7 8 9}

How does the drug varenicline differ from other smoking cessation treatments for people living with HIV?

Varenicline is unique because it has been shown to be safe and effective for smoking cessation in people living with HIV, without negatively affecting their HIV treatment. It also appears to improve psychological well-being by reducing depression and anxiety, which is particularly beneficial for this population. ^{1 5 6 10 11}

Research Team

Elizabeth Connick, MD

Principal Investigator

University of Arizona

Michael Grandner, PhD

Principal Investigator

University of Arizona

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Health Approach 1 to Reduce Smoking (Other)
• Health Approach 2 to Reduce Smoking (Other)
• Smoking Cessation Counseling (Behavioral)
• Varenicline (Nicotinic Acetylcholine Receptor Partial Agonist)

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.

Participant Groups

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 Canada, Japan for the following indications:

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+

Dr. Richard Carmona

University of Arizona

Chief Medical Officer since 2021

MD, University of Arizona

Dr. Evan Unger

University of Arizona

Chief Executive Officer since 2021

PhD in Medical Imaging, University of Arizona

University of Delaware

Collaborator

Trials

167

Recruited

25,700+

Harry Jiannan Wang

University of Delaware

Chief Executive Officer since 2023

PhD in Business Administration from Pennsylvania State University

Dr. Kenneth Gene Yancey

University of Delaware

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Improved clinical outcomes among persons with HIV who quit smoking. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A pilot clinical trial of varenicline for smoking cessation in black smokers. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. [2015]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Addressing varenicline adherence through repackaging in a dose administration aid. [2022]

5. United States 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. [2022]

6. United States 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. [2021]

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

Treatment of nicotine dependence with Chantix (varenicline). [2015]

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

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

9. Netherlands 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. [2018]

10. 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]

11. Ireland pubmed.ncbi.nlm.nih.gov

Placebo-controlled randomized clinical trial testing the efficacy and safety of varenicline for smokers with HIV. [2023]