Trial reportAddiction (Abingdon, England)2021
Effect of varenicline directly observed therapy versus varenicline self-administered therapy on varenicline adherence and smoking cessation in methadone-maintained smokers: a randomized controlled trial.
Trial report in Addiction (Abingdon, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- Addressing tobacco use in the context of opioid use disorder: A systematic review of smoking cessation interventions.The American journal on addictions · 2026Pooled it
- Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023Pooled it
- Timing of smoking cessation treatment integrated into outpatient treatment with medications for opioid use disorder: Feasibility trial.Journal of substance abuse treatment · 2022Trial
- The impact of menthol cigarette use on quit attempts and abstinence among smokers with opioid use disorder.Addictive behaviors · 2021Trial
- Multimethod feasibility evaluation of smoking cessation intervention for patients receiving opioid agonist therapy.Pilot and feasibility studies · 2025Article
- Identifying determinants of varenicline adherence using the Theoretical Domains framework: a rapid review.BMC public health · 2024Review
- Impact of the Ottawa model on opiate screening and smoking cessation in methadone-treated patients with opioid use disorder: A retrospective cohort analysis.Tobacco induced diseases · 2024Article
- Medication Adherence in Tobacco Cessation Clinical Trials.Addiction neuroscience · 2023Article
- Article
- Article
- Impact of Nicotine Replacement Therapy Sampling on Cessation-Related Processes.Journal of addiction medicineArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
Abstract
BACKGROUND AND
aimsLevel of adherence to tobacco cessation medication regimens is believed to be causally related to medication effectiveness. This study aimed to evaluate the efficacy of varenicline directly observed therapy (DOT) on varenicline adherence and smoking cessation rates among smokers with opioid use disorder (OUD) receiving methadone treatment.
designMulticenter, parallel-group two-arm randomized controlled trial.
settingUrban opioid treatment program (OTP) in the Bronx, New York, USA.
participantsDaily smokers of ≥ 5 cigarettes/day, interested in quitting (ladder of change score 6-8), in methadone treatment for ≥ 3 months, attending OTP ≥ 3 days/week. Participants' mean age was 49 years, 56% were male, 44% Latino, 30% Black, and they smoked a median of 10 cigarettes/day.
interventionsIndividual, block, random assignment to 12 weeks of varenicline, either directly observed with methadone (DOT, n = 50) or via unsupervised self-administered treatment (SAT, n = 50). MEASUREMENTS: The primary outcome was adherence measured by pill count. The secondary outcome was 7-day point prevalence tobacco abstinence verified by expired carbon monoxide (CO) < 8 parts per million.
findingsRetention at 24 weeks was 92%. Mean adherence was 78.5% [95% confidence interval (CI) = 71.8-85.2%] in the DOT group versus 61.8% in the SAT group (95% CI = 55.0-68.6%); differences were driven by DOT effects in the first 6 weeks. CO-verified abstinence did not differ between groups during the intervention (P = 0.26), but was higher in the DOT than the SAT group at intervention end (DOT = 18% versus SAT = 10%, difference = 8%, 95% CI = -13, 28); this difference was not significant (P = 0.39) and was not sustained at 24-week follow-up.
conclusionsAmong daily smokers attending opioid treatment programs, opioid treatment program-based varenicline directly observed therapy was associated with early increases in varenicline adherence compared with self-administered treatment, but findings were inconclusive as to whether directly observed therapy was associated with a difference in tobacco abstinence.
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