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Placebo-controlled randomized clinical trial testing the efficacy and safety of varenicline for smokers with HIV
- Source :
- Drug Alcohol Depend
- Publication Year :
- 2018
-
Abstract
- Background 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. Methods This was a single-site randomized, double-blind, placebo-controlled, phase 3 clinical trial (NCT01710137). PLWH on antiretroviral therapy (ART) who were treatment-seeking daily smokers were randomized (1:1) to 12 weeks of varenicline (n = 89) or placebo (n = 90). All participants were offered six smoking cessation behavioral counseling sessions. The primary outcome was 7-day point prevalence abstinence, confirmed with breath carbon monoxide, at Weeks 12 and 24. Continuous abstinence and time to relapse were secondary outcomes. Safety measures were treatment-related side effects, adverse events, blood pressure, viral load, and ART adherence. Results Of the 179 smokers, 81% were African American, and 68% were male. Varenicline increased cessation at Week 12 (28.1% vs. 12.1%; OR = 4.54, 95% CI:1.83−11.25, P = .001). Continuous abstinence from Week 9 to 12 was higher for varenicline vs. placebo (23.6% vs. 10%; OR = 4.65, 95% CI:1.71−12.67, P = .003); at Week 24, there was no effect of varenicline for point prevalence (14.6% vs. 10%), continuous abstinence (10.1% vs. 6.7%), or time to relapse (Ps > .05). There were no differences between varenicline and placebo on safety measures (Ps > .05). Conclusions Varenicline is safe and efficacious for short-term smoking cessation among PLWH and should be used to reduce tobacco-related life-years lost in this population.
- Subjects :
- Adult
Male
medicine.medical_specialty
media_common.quotation_subject
medicine.medical_treatment
Population
HIV Infections
Toxicology
Placebo
Article
law.invention
03 medical and health sciences
chemistry.chemical_compound
Young Adult
0302 clinical medicine
Randomized controlled trial
Double-Blind Method
law
Internal medicine
medicine
Humans
Pharmacology (medical)
030212 general & internal medicine
Prospective Studies
Adverse effect
education
Varenicline
media_common
Aged
Pharmacology
education.field_of_study
Smoking Cessation Agents
Smokers
business.industry
Tobacco Use Disorder
Abstinence
Middle Aged
Psychiatry and Mental health
Treatment Outcome
chemistry
Smoking cessation
Female
Smoking Cessation
Breath carbon monoxide
business
030217 neurology & neurosurgery
Subjects
Details
- ISSN :
- 18790046
- Volume :
- 200
- Database :
- OpenAIRE
- Journal :
- Drug and alcohol dependence
- Accession number :
- edsair.doi.dedup.....ee848e85a74dc52a9f4ff254eb0cd986