Update of statistical analysis plan for: Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR)

• Published in: Current controlled trials in cardiovascular medicine 2024-01, Vol.25 (1), p.29-29, Article 29
• Main Authors: Druckrey-Fiskaaen, Karl Trygve, Madebo, Tesfaye, Daltveit, Jan Tore, Vold, Jørn Henrik, Furulund, Einar, Lid, Torgeir Gilje, Fadnes, Lars Thore
• Format: Article
• Language: English
• Subjects: Addictions; Analgesics, Opioid - adverse effects; Analysis; Behavior Therapy; Carbon monoxide; Care and treatment; Cigarettes; Clinical trials; Drug abuse; Drug withdrawal; Education; Hospitals; Humans; Influence; Intervention; Mathematical statistics; Methods; Missing data; Narcotics; Opioid agonist treatment; Public health; Randomised controlled trial; Randomized Controlled Trials as Topic; Self report; Sensitivity analysis; Smoking; Smoking Cessation; Smoking cessation products; Smoking cessation programs; Statistical analysis; Statistical analysis plan; Substance abuse; Tobacco Use Cessation Devices - adverse effects
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-023-07894-w

This protocol paper presents an updated statistical analysis plan of the protocol of a randomised controlled trial. The randomised controlled trial investigates the effect of integrating smoking cessation interventions at outpatient opioid agonist therapy (OAT) clinics for persons with opioid dependency receiving OAT medication. The intervention group receives weekly follow-up including a short behavioural intervention and provision of nicotine replacement products. The control group receives standard treatment. The duration of the intervention is 16 weeks and the follow-up was completed by the end of October 2023. The primary outcome is defined as the proportion of participants reducing the number of cigarettes smoked by at least a 50% at week 16 of the intervention period. The primary outcome will be analysed according to intention-to-treat principles. Missing outcome data will be set equal to the baseline values. Development and reporting of the statistical analysis plan follow the Guidelines for the Content of Statistical Analysis Plans in Clinical Trials.Trial registration ClinicalTrials.gov NCT05290025. Registered on 22 March 2022.