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Randomized Controlled Trial
. 2021 Apr;116(4):902-913.
doi: 10.1111/add.15240. Epub 2020 Oct 13.

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

Shadi Nahvi  1   2 , Tangeria R Adams  1 , Yuming Ning, Chenshu Zhang  1 , Julia H Arnsten  1   2   3
Affiliations
Randomized Controlled Trial

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

Shadi Nahvi et al. Addiction. 2021 Apr.

Abstract

Background and aims: Level 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.

Design: Multicenter, parallel-group two-arm randomized controlled trial.

Setting: Urban opioid treatment program (OTP) in the Bronx, New York, USA.

Participants: Daily 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.

Interventions: Individual, 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.

Findings: Retention 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.

Conclusions: Among 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.

Trial registration: ClinicalTrials.gov NCT01378858.

Keywords: Adherence; directly observed therapy; methadone maintenance; opioid use disorder; smoking cessation; varenicline.

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Conflict of interest statement

Declarations of interest:

This project was supported by the National Institutes of Health grant numbers K23DA025736, R25DA023021, R25GM104547, and P30AI051519. Authors receive no direct or indirect funding from the tobacco, alcohol, cannabis, or gaming industries. Dr. Arnsten and Dr. Nahvi receive investigator-initiated grant support from Pfizer. Neither the funding sources nor Pfizer had any role in the study design; data collection, analysis and interpretation; writing the manuscript; or the decision to submit the manuscript for publication.

Figures

Figure 1.
Figure 1.
Flow chart of participant screening, enrollment and follow up
Figure 2.
Figure 2.. Adherence rates over time
Adherence rates and their 95% confidence intervals are model-based estimates obtained from linear mixed effects models that adjust for time, clinical site, and HIV status. DOT = directly observed therapy; SAT = self-administered therapy
See this image and copyright information in PMC

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