Varenicline + PSF-M for Smoking Cessation in HIV/AIDS
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen byGina Kruse, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Massachusetts General Hospital
Must be taking: Varenicline
Must not be taking: Antipsychotics
Disqualifiers: Pregnancy, Breastfeeding, Liver failure, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial tests a mobile app and a medication to help people with HIV quit smoking. The app provides tips and support, while the medication reduces cravings. The study aims to see if this combination is more effective than standard care.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must be able to use varenicline safely, which will be evaluated by your primary provider.
What data supports the effectiveness of the drug Varenicline for smoking cessation in people living with HIV/AIDS?
Is the combination of Varenicline and PSF-M safe for smoking cessation in people with HIV/AIDS?
Varenicline, used for smoking cessation, has been studied in people with HIV and is generally considered safe, though common side effects include nausea and sleep disturbances. Serious side effects are rare, but monitoring for changes in mood or behavior is recommended. In studies, it did not negatively affect HIV treatment outcomes.25678
How is the drug varenicline unique for smoking cessation in people with HIV/AIDS?
Varenicline is unique for smoking cessation in people with HIV/AIDS because it has been specifically studied for safety and effectiveness in this population, showing it can help reduce smoking without negatively affecting HIV treatment outcomes. It works by reducing nicotine withdrawal symptoms and cravings, and it has been found to be more effective than some other smoking cessation aids like bupropion.12569
Eligibility Criteria
This trial is for adults over 18 with HIV who smoke tobacco, have a viral load under 1000 copies/mL, and CD4 count above 200 cells/mm3. They must read at a 6th-grade level in Tamil, Telugu or English and can safely use varenicline. Women must agree to contraception during the study.Inclusion Criteria
You have recently been diagnosed with HIV, your viral load is below 1000 copies/mL and your CD4 count is above 200 cells/mm3.
I am 18 years old or older.
You are a current smoker or dual tobacco user, confirmed by exhaled carbon monoxide of 7 parts per million or higher.
See 3 more
Exclusion Criteria
I have had a heart attack or unstable chest pain in the last 30 days.
My liver enzymes are high or my kidney function is low.
I have a history of psychosis or am taking anti-psychotic medications.
See 8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive Varenicline and Positively Smoke Free-Mobile intervention
12 weeks
Multiple visits (in-person and virtual)
Follow-up
Participants are monitored for tobacco abstinence and safety
12 weeks
2 visits (in-person)
Treatment Details
Interventions
- Positively Smoke Free Mobile (PSF-M) (Behavioral Intervention)
- Standard Care (Behavioral Intervention)
- Varenicline (Nicotinic Acetylcholine Receptor Partial Agonist)
Trial OverviewThe study tests an intervention to help people with HIV quit smoking using PSF-M (a mobile behavioral program) and Varenicline (a medication). Participants will receive either this combination or standard care to see which helps more with quitting.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Varenicline + Positively Smoke Free - MobileExperimental Treatment2 Interventions
Offer of varenicline per package dosing with dose escalation over week 1: 0.5 mg once daily on days 1 - 3, 0.5 mg twice daily on days 4 -7, followed by 1.0 mg twice daily on days 8 to 84.
Offer of Positively Smoke Free Mobile delivered by mobile phone including 42 days of content, tailored to individual quit date.
Group II: Standard CareActive Control1 Intervention
Brief advice to quit tobacco Offer of referral to the national tobacco quitline
Varenicline is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Chantix for:
- Smoking cessation
- Dry eye disease
🇪🇺 Approved in European Union as Champix for:
- Smoking cessation
🇨🇦 Approved in Canada as Champix for:
- Smoking cessation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
University of ColoradoAurora, CO
Massachusetts General Hospital Cancer CenterBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
University of Colorado, DenverLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Placebo-controlled randomized clinical trial testing the efficacy and safety of varenicline for smokers with HIV. [2023]People living with HIV/AIDS (PLWH) smoke tobacco at higher rates and have more difficulty quitting than the general population, which contributes to significant life-years lost. The effectiveness of varenicline, one of the most effective tobacco dependence treatments, is understudied in HIV. We evaluated the safety and efficacy of varenicline for smoking cessation among PLWH.
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]Tobacco smoking is common in people living with HIV, but high-quality evidence on interventions for smoking cessation is not available in this population. We aimed to assess the efficacy and safety of varenicline with counselling to aid smoking cessation in people living with HIV.
Improved clinical outcomes among persons with HIV who quit smoking. [2021]Quitting smoking among people living with HIV/AIDS (PLWHA) is a priority. However, PLWHA and clinicians working with PLWHA are reluctant to use tobacco use treatments out of concern that smoking cessation can diminish anti-retroviral therapy (ART) adherence and quality of life (QoL) and increase psychiatric symptoms. This secondary analysis from a placebo-controlled varenicline trial for tobacco dependence among PLWHA (N = 179) examined if smoking cessation at the end of treatment (EOT) was associated with changes in ART adherence, QoL, anxiety and depression symptoms, and varenicline side effects. ART adherence was not affected by smoking cessation (p > 0.05), remaining ≥98% for all participants. Across 8 QoL subscales, 7 remained unchanged over time across smokers and abstainers; side effects were not associated with cessation. Controlling for baseline smoking rate, adherence to varenicline/placebo and counseling, and treatment arm, participants who had quit smoking at EOT reported a significant reduction in depression (β = -1.657, 95% CI: -2.893, -0.422, p = .009) and anxiety (β = -1.434, 95% CI: -2.812, -0.56, p = .041) and increased life satisfaction (β = 0.88, 95% CI: 0.21, 3.275, p = .027). When PLWHA quit smoking they may not experience adverse clinical outcomes including ART non-adherence and may experience beneficial psychological effects, supporting the use of FDA-approved smoking cessation treatments among PLWHA.
Effects of varenicline on abstinence and smoking reward following a programmed lapse. [2021]Varenicline (Chantix®) is an efficacious first-line medication for smoking cessation. Studies suggest that one mechanism by which varenicline facilitates sustained smoking abstinence is by reducing the likelihood of relapse to smoking when a lapse, or slip, occurs during a quit attempt. The present study extends this line of research by conducting a prospective laboratory study to examine the relapse prevention effects of varenicline following a programmed lapse.
Safety and tolerability of varenicline tartrate (Champix(®)/Chantix(®)) for smoking cessation in HIV-infected subjects: a pilot open-label study. [2021]The prevalence of smoking in HIV-infected subjects is high. As a smoking cessation aid, varenicline (Champix(®), Pfizer, Saint-Laurent, QC, Canada or Chantix(®), Pfizer, Mission, KS) has not been previously evaluated in HIV-infected smokers. In this multicenter pilot open label study, varenicline 1.0 mg was used twice daily for 12 weeks with dose titration in the first week. Adverse events (AEs) during the treatment period were recorded. Changes from baseline in laboratory tests, vital signs, daily cigarette consumption, nicotine dependence, and withdrawal were measured through week 24. Self-reported abstinence was validated by serum cotinine at week 12. We enrolled 36 subjects with a mean of 29 pack-years of smoking and a minimum of 4 cigarettes per day. All but 1 were male, 33 (92%) were white. The most frequently reported AEs were nausea (33%), abnormal dreams (31%), affect lability (19%), and insomnia (19%). Six (17%) subjects discontinued varenicline due to AEs. No grade 3/4 laboratory abnormalities or serious AEs occurred during the study. There was no significant change in HIV viral load. CD4 counts increased by 69 cells/mm3 (p = 0.001) at week 24. Serum cotinine-verified 4-week continuous abstinence rate through weeks 9-12 was 42% (95% confidence interval [CI]: 26-58%). AEs and abstinence rates were comparable to those in published randomized controlled trials conducted in generally healthy HIV-negative smokers. Varenicline was safe and appears effective among HIV-infected smokers in this exploratory study, although AEs were common. The most common AE was nausea, with no adverse effect on HIV treatment outcome. Close monitoring of liver enzymes and blood pressure is recommended for HIV-positive smokers taking varenicline.
Treatment of nicotine dependence with Chantix (varenicline). [2015]Varenicline is the generic name for Chantix, the newest drug available for the treatment of tobacco dependence. In a randomized controlled clinical trial, the abstinence rate at 1 year for patients using varencline was superior to that of patients in the group using bupropion SR (Zyban) and in the placebo group (11). Varenicline reduces nicotine withdrawal symptoms, cigarette craving and nicotine satisfaction. Post-market reports prompted a warning of serious adverse neuropsychiatric events in patients taking varenicline. As is the case with any surgical procedure and/or prescription medication, full disclosure of the risks and benefits should be discussed with the patient. The significant health benefits of quitting smoking should be weighed against the individual's risk of adverse events associated with the use of varenicline for smoking cessation.
Varenicline in smoking cessation. [2017]Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, is the newest drug in the armamentarium of tobacco-addiction treatment. Improved smoking quit rates with varenicline are seen in comparison with other pharmacotherapies or behavioral treatments alone. Efficacy, tolerability and safety have been demonstrated in healthy smokers and in smokers with cardiovascular or pulmonary comorbidity, as well as in smokeless tobacco users. Varenicline is started 1 week before a target quit date, uptitrated to 1 mg twice daily, and continued for 12-24 weeks. Post-marketing reports have led to labeling changes to monitor patients for change in behavior, hostility, agitation, depressed mood and suicide-related events. Varenicline's pharmacological profile does not clearly explain an association with these adverse events. A review of placebo-controlled studies found that varenicline was not associated with self-reported neuropsychiatric symptoms, with the exception of sleep disorders. Data in smokers with psychiatric problems are limited.
Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis. [2022]Varenicline (Chantix), Champix) has shown efficacy and tolerability as an aid to smoking cessation. In postmarketing surveillance, neuropsychiatric symptoms have appeared; however, their incidence and causal relationship to varenicline is not known.
Safety of varenicline among smokers enrolled in the lung HIV study. [2021]The prevalence of smoking is high among the human immunodeficiency virus (HIV)-infected population, yet there are few studies of tobacco dependence treatment in this population. This paper reports the safety of varenicline versus nicotine replacement therapy (NRT) and describes preliminary results about the effectiveness of varenicline versus NRT in HIV-infected smokers.