Trial reportDepression and anxiety2022
The effects of varenicline, bupropion, nicotine patch, and placebo on smoking cessation among smokers with major depression: A randomized clinical trial.
Trial report in Depression and anxiety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01456936 (A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- Korean Clinical Practice Guideline of Korean Society for Research on Nicotine and Tobacco (KSRNT) and National Evidence-based Healthcare Collaborating Agency (NECA) on Treatment of Tobacco Use 2024.Journal of Korean medical science · 2025Guideline
- Chinese Stroke Association guidelines for clinical management of ischaemic cerebrovascular diseases: executive summary and 2023 update.Stroke and vascular neurology · 2023Guideline
- Baseline predictors of smoking cessation among individuals with current or past major depressive disorder following treatment with varenicline and intensive behavioral treatment.Drug and alcohol dependence · 2025Trial
- Efficacy and safety of combination behavioral activation for smoking cessation and varenicline for treating tobacco dependence among individuals with current or past major depressive disorder: A 2 × 2 factorial, randomized, placebo-controlled trial.Addiction (Abingdon, England) · 2023Trial
- Smoking cessation for people with severe mental illness: systematic review and network meta-analysis.BMJ medicine · 2026Article
- Smoking, Sociodemographic Characteristics, and Health History among Adults with Mental Illness in Puerto Rico.Puerto Rico health sciences journal · 2025Article
- Polish consensus on smoking cessation intervention within lung cancer screening 1.Archives of medical science : AMS · 2025Article
- Smoking cessation pharmacotherapy; varenicline or bupropion?Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2024Review
- Hospital-Initiated Smoking Cessation Among Patients Admitted with Behavioral Health Conditions.Journal of general internal medicine · 2024Article
- Effect of early medication adherence on behavioral treatment utilization and smoking cessation among individuals with current or past major depressive disorder.Addictive behaviors · 2024Article
- Evidence-Based Guideline for the Treatment of Smoking Cessation Provided by the National Health Insurance Service in Korea.Korean journal of family medicine · 2024Article
- Bupropion Mediated Effects on Depression, Attention Deficit Hyperactivity Disorder, and Smoking Cessation.Health psychology research · 2023Article
- Effects of varenicline on the serum levels of olanzapine in male patients with Schizophrenia: a randomized controlled trial.Frontiers in psychiatry · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 1 country.
Funding
Abstract
importanceImproving treatment outcomes for smokers with major depressive disorder (MDD) can have significant public health implications.
objectiveTo evaluate the safety and efficacy of smoking cessation pharmacotherapy among smokers with MDD.
designSecondary analysis of a randomized, double-blind, active- (nicotine patch) and placebo-controlled trial of 12 weeks of either varenicline or bupropion with a 12-week follow-up.
participantsCommunity volunteers 18-75 years of age; smoke 10+ cigarettes/day; with clinically stable MDD (N = 2635) or no psychiatric disorder (N = 4028), from 140 sites in 16 countries.
interventionTwelve weeks of pharmacotherapy (placebo [PLA], nicotine replacement therapy [NRT], bupropion [BUP], varenicline [VAR]) plus brief cessation counseling. MEASURE(S): Primary safety outcome: the occurrence of ≥1 treatment-emergent, moderate to severe neuropsychiatric adverse event (NPSAE). Primary efficacy outcome: biochemically confirmed continuous abstinence (CA) during the final 4 weeks of treatment (Weeks 9-12).
resultsA total of 6653 participants (56% female; 39% MDD) ~47 years old. Risk of NPSAEs did not differ by medication for MDD. MDD had higher risk (p < .0001) for NPSAEs than the NPC. Efficacy (6653; intent-to-treat): CA rates for MDD versus NPC respectively were 31.2% versus 38.0% VAR; 23.0% versus 26.1% BUP; 22.6% versus 26.4% NRT; and 13.4% versus 13.7% PLA but no differential treatment effect was noted within the cohorts. All active treatments differed from PLA but VAR showed the largest effect.
conclusionsResults suggest that for MDD smokers, inclusive of those with recurrent episode, varenicline plus counseling may be the best pharmacological option for the treatment of smoking given its greater efficacy effect size and similar risk of NPSAEs.
trial registrationClinicalTrials.gov Identifier: NCT01456936. https://clinicaltrials.gov/ct2/show/NCT01456936.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.