Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR).
Study Goal
The researchers aimed to evaluate the effectiveness of an integrated smoking cessation intervention, including nicotine chewing gum, for patients receiving opioid agonist therapy (OAT) who smoke tobacco.
Results Summary
The study protocol describes a multicentre randomized controlled trial to assess smoking cessation or reduction, with primary outcomes measured at 16 weeks and sustained effects evaluated at 1 year. Secondary outcomes include changes in psychological well-being, inflammation markers, physical health, quality of life, and fatigue.
Population
Daily tobacco-smoking patients receiving OAT in outpatient clinics in Bergen and Stavanger, Norway.
Effective Dosage
Not specified (prescription-free nicotine replacement products, including chewing gum, were provided).
Duration
16 weeks, with an optional 8-week extension.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
integrated smoking cessation intervention | decrease | smoking cessation | patients receiving OAT and smoking tobacco | - | aimed at | #1 |
smoking cessation therapy | decrease | smoking cessation | patients randomised for the intervention arm | - | will be offered | #2 |
smoking cessation therapy | neutral | weekly brief behavioural interventions | - | - | consisting of | #3 |
smoking cessation therapy | neutral | prescription-free nicotine replacement products | - | - | consisting of | #4 |
smoking cessation intervention | neutral | psychoeducational techniques with components from motivational interviewing | - | - | includes | #5 |
smoking cessation intervention | neutral | nicotine replacement products such as nicotine lozenges, patches, and chewing gum | - | - | includes | #6 |
integrated smoking cessation treatment | increase | standard care | - | - | is superior to | #7 |
integration of other treatments to standard OAT care | increase | adherence | - | - | improves | #8 |
integration of other treatments to standard OAT care | increase | completion rates | - | - | improves | #9 |
BACKGROUND: About 85% of patients receiving opioid agonist therapy (OAT) for opioid dependence are smoking tobacco. Although smoke-related pulmonary diseases are significant contributors to morbidity and mortality, few smoking cessation interventions are evaluated within this group, and few OAT patients are offered smoking cessation as an integrated part of their addiction treatment. This study protocol describes an integrated smoking cessation intervention aimed at patients receiving OAT and smoking tobacco. METHODS: This is a multicentre, randomised controlled clinical trial that will recruit 266 daily tobacco smoking patients receiving OAT in OAT outpatient clinics in Bergen and Stavanger, Norway. The patients randomised for the intervention arm will be offered smoking cessation therapy consisting of weekly brief behavioural interventions and prescription-free nicotine replacement products. In the control arm, patients will receive standard care without any added interventions related to smoking cessation. The smoking cessation intervention includes psychoeducational techniques with components from motivational interviewing, and nicotine replacement products such as nicotine lozenges, patches, and chewing gum. The duration of the intervention is 16 weeks, with the option of extending it by a further 8 weeks. The main outcomes are measured at 16 weeks after initiation of the intervention, and sustained effects are evaluated 1 year after intervention initiation. The primary outcome is smoking cessation verified by carbon monoxide (CO) levels or at least a 50% reduction in the number of cigarettes smoked. Secondary outcomes are changes in psychological well-being, biochemical inflammation markers, changes in physical health, quality of life, and fatigue. DISCUSSION: Integration of other treatments to standard OAT care improves adherence and completion rates providing another rationale for integrated smoking cessation treatment. Thus, if integrated smoking cessation treatment is superior to standard care, this trial provides important information on further scale-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT05290025. Registered on 22 March 2022.