BAReNikotin
Trial question
What is the role of integrated nicotine replacement and behavioral support in reducing cigarette use at opioid agonist therapy clinics?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 259
259 patients (80 female, 179 male).
Inclusion criteria: patients with opioid use disorder receiving opioid agonist therapy and smoking ≥ 1 cigarette per day.
Key exclusion criteria: allergies or prior anaphylactic reactions to the medication used; smoking < 3 times/week; receipt of smoking cessation medications at inclusion.
Interventions
N=135 integrated smoking reduction intervention (opioid agonist therapy with nicotine replacement and weekly behavioral support for 16 week).
N=124 standard opioid agonist therapy (opioid agonist therapy without smoking intervention).
Primary outcome
≥ 50% reduction in number of cigarettes smoked, self-reported as cigarette use in the past 7 days at week 16
29.6%
16.9%
29.6 %
22.2 %
14.8 %
7.4 %
0.0 %
Integrated smoking reduction
intervention
Standard opioid agonist
therapy
Significant
increase ▲
NNT = 7
Significant increase in ≥ 50% reduction in the number of cigarettes smoked, self-reported as cigarette use in the past 7 days at week 16 (29.6% vs. 16.9%; OR 2.07, 95% CI 1.14 to 3.75).
Secondary outcomes
No significant difference in smokers at week 16 (99.3% vs. 96%; AD 3.3%, 95% CI -0.4 to 7).
No significant difference in mean CO levels in the exhaled air at week 16 (15.74 ppm vs. 15.9 ppm; AD -0.16 ppm, 95% CI -2.48 to 2.15).
No significant difference in mean cigarettes smoked at week 16 (8.5 cigarettes/day vs. 9.7 cigarettes/day; AD 1.2 cigarettes/day, 95% CI -3 to 0.5).
Conclusion
In patients with opioid use disorder receiving opioid agonist therapy and smoking ≥ 1 cigarette per day, integrated smoking reduction intervention was superior to standard opioid agonist therapy with respect to ≥ 50% reduction in the number of cigarettes smoked, self-reported as cigarette use in the past 7 days at week 16.
Reference
Karl Trygve Druckrey-Fiskaaen, Tesfaye Madebo, Jan Tore Daltveit et al. Integrated Nicotine Replacement and Behavioral Support to Reduce Smoking in Opioid Agonist Therapy: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Apr 1;82(4):406-414.
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