Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR)
Abstract 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...
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| Format: | Article |
| Language: | English |
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BMC
2022-08-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06560-x |
| _version_ | 1797362930291834880 |
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| author | Karl Trygve Druckrey-Fiskaaen Einar Furulund Jan Tore Daltveit Jørn Henrik Vold Torgeir Gilje Lid Tesfaye Madebo Lars Thore Fadnes for the ATLAS4LAR Study Group |
| author_facet | Karl Trygve Druckrey-Fiskaaen Einar Furulund Jan Tore Daltveit Jørn Henrik Vold Torgeir Gilje Lid Tesfaye Madebo Lars Thore Fadnes for the ATLAS4LAR Study Group |
| author_sort | Karl Trygve Druckrey-Fiskaaen |
| collection | DOAJ |
| description | Abstract 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 |
| first_indexed | 2024-03-08T16:13:28Z |
| format | Article |
| id | doaj.art-8ce36699f29945a4a813299a3247b7bb |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-08T16:13:28Z |
| publishDate | 2022-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-8ce36699f29945a4a813299a3247b7bb2024-01-07T12:43:37ZengBMCTrials1745-62152022-08-0123111110.1186/s13063-022-06560-xIntegration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR)Karl Trygve Druckrey-Fiskaaen0Einar Furulund1Jan Tore Daltveit2Jørn Henrik Vold3Torgeir Gilje Lid4Tesfaye Madebo5Lars Thore Fadnes6for the ATLAS4LAR Study GroupBergen Addiction Research, Department of Addiction Medicine, Haukeland University HospitalBergen Addiction Research, Department of Addiction Medicine, Haukeland University HospitalBergen Addiction Research, Department of Addiction Medicine, Haukeland University HospitalBergen Addiction Research, Department of Addiction Medicine, Haukeland University HospitalCentre for Alcohol and Drug Research, Stavanger University HospitalBergen Addiction Research, Department of Addiction Medicine, Haukeland University HospitalBergen Addiction Research, Department of Addiction Medicine, Haukeland University HospitalAbstract 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 2022https://doi.org/10.1186/s13063-022-06560-xSmoking cessationNicotine replacementOpiate substitution treatmentBehavioural interventionSubstance abuse treatment centres |
| spellingShingle | Karl Trygve Druckrey-Fiskaaen Einar Furulund Jan Tore Daltveit Jørn Henrik Vold Torgeir Gilje Lid Tesfaye Madebo Lars Thore Fadnes for the ATLAS4LAR Study Group Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR) Trials Smoking cessation Nicotine replacement Opiate substitution treatment Behavioural intervention Substance abuse treatment centres |
| title | Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR) |
| title_full | Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR) |
| title_fullStr | Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR) |
| title_full_unstemmed | Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR) |
| title_short | Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR) |
| title_sort | integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco protocol for a randomised controlled trial atlas4lar |
| topic | Smoking cessation Nicotine replacement Opiate substitution treatment Behavioural intervention Substance abuse treatment centres |
| url | https://doi.org/10.1186/s13063-022-06560-x |
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