Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial
Abstract Background Opioids accounted for 75% of drug overdoses in the USA in 2020, with rural states particularly impacted by the opioid crisis. While medication-assisted treatment (MAT) with Suboxone remains one of the more efficacious treatments for opioid use disorder (OUD), approximately 40% of...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-04-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07213-3 |
| _version_ | 1797849892624793600 |
|---|---|
| author | Ronald G. Thompson Mary Bollinger Michael J. Mancino Deborah Hasin Xiaotong Han Keith A. Bush Clint D. Kilts G. Andrew James |
| author_facet | Ronald G. Thompson Mary Bollinger Michael J. Mancino Deborah Hasin Xiaotong Han Keith A. Bush Clint D. Kilts G. Andrew James |
| author_sort | Ronald G. Thompson |
| collection | DOAJ |
| description | Abstract Background Opioids accounted for 75% of drug overdoses in the USA in 2020, with rural states particularly impacted by the opioid crisis. While medication-assisted treatment (MAT) with Suboxone remains one of the more efficacious treatments for opioid use disorder (OUD), approximately 40% of people receiving Suboxone for outpatient MAT for OUD (MOUD) relapse within the first 6 months of treatment. We developed the smartphone app-based intervention OptiMAT as an adjunctive intervention to improve MOUD outcomes. The aims of this study are to (1) evaluate the efficacy of adjunctive OptiMAT use in reducing opioid misuse among people receiving MOUD and (2) evaluate the role of specific OptiMAT features in reducing opioid misuse, including the use of GPS-driven just-in-time intervention. Methods We will conduct a two-arm, single-blind, randomized controlled trial of adults receiving outpatient MOUD in the greater Little Rock AR area. Participants are English-speaking adults ages 18 or older recently enrolled in outpatient MOUD at one of our participating study clinics. Participants will be allocated via 1:1 randomized block design to (1) MOUD with adjunctive use of OptiMAT (MOUD+OptiMAT) or (2) MOUD without OptiMAT (MOUD-only). Our blinded research statistician will evaluate differences between the two groups in opioid misuse (as determined by quantitative urinalysis conducted by clinical lab staff blinded to group membership) during the 6-months following study enrolment. Secondary analyses will evaluate if OptiMAT-usage patterns within the MOUD+OptiMAT group predict opioid misuse or continued abstinence. Discussion This study will test if adjunctive use of OptiMAT improve MOUD outcomes. Study findings could lead to expansion of OptiMAT into rural clinical settings, and the identification of OptiMAT features which best predict positive clinical outcome could lead to refinement of this and similar smartphone app-based interventions. Trial registration ClinicalTrials.gov identifier: NCT05336188 , registered March 21, 2022. |
| first_indexed | 2024-04-09T18:51:28Z |
| format | Article |
| id | doaj.art-3f749e87043d481cbbcc2353e886fdb4 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T18:51:28Z |
| publishDate | 2023-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-3f749e87043d481cbbcc2353e886fdb42023-04-09T11:26:05ZengBMCTrials1745-62152023-04-0124111310.1186/s13063-023-07213-3Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trialRonald G. Thompson0Mary Bollinger1Michael J. Mancino2Deborah Hasin3Xiaotong Han4Keith A. Bush5Clint D. Kilts6G. Andrew James7Department of Psychiatry, University of Arkansas for Medical SciencesDepartment of Psychiatry, University of Arkansas for Medical SciencesDepartment of Psychiatry, University of Arkansas for Medical SciencesDepartment of Epidemiology, Columbia UniversityDepartment of Psychiatry, University of Arkansas for Medical SciencesDepartment of Psychiatry, University of Arkansas for Medical SciencesDepartment of Psychiatry, University of Arkansas for Medical SciencesDepartment of Psychiatry, University of Arkansas for Medical SciencesAbstract Background Opioids accounted for 75% of drug overdoses in the USA in 2020, with rural states particularly impacted by the opioid crisis. While medication-assisted treatment (MAT) with Suboxone remains one of the more efficacious treatments for opioid use disorder (OUD), approximately 40% of people receiving Suboxone for outpatient MAT for OUD (MOUD) relapse within the first 6 months of treatment. We developed the smartphone app-based intervention OptiMAT as an adjunctive intervention to improve MOUD outcomes. The aims of this study are to (1) evaluate the efficacy of adjunctive OptiMAT use in reducing opioid misuse among people receiving MOUD and (2) evaluate the role of specific OptiMAT features in reducing opioid misuse, including the use of GPS-driven just-in-time intervention. Methods We will conduct a two-arm, single-blind, randomized controlled trial of adults receiving outpatient MOUD in the greater Little Rock AR area. Participants are English-speaking adults ages 18 or older recently enrolled in outpatient MOUD at one of our participating study clinics. Participants will be allocated via 1:1 randomized block design to (1) MOUD with adjunctive use of OptiMAT (MOUD+OptiMAT) or (2) MOUD without OptiMAT (MOUD-only). Our blinded research statistician will evaluate differences between the two groups in opioid misuse (as determined by quantitative urinalysis conducted by clinical lab staff blinded to group membership) during the 6-months following study enrolment. Secondary analyses will evaluate if OptiMAT-usage patterns within the MOUD+OptiMAT group predict opioid misuse or continued abstinence. Discussion This study will test if adjunctive use of OptiMAT improve MOUD outcomes. Study findings could lead to expansion of OptiMAT into rural clinical settings, and the identification of OptiMAT features which best predict positive clinical outcome could lead to refinement of this and similar smartphone app-based interventions. Trial registration ClinicalTrials.gov identifier: NCT05336188 , registered March 21, 2022.https://doi.org/10.1186/s13063-023-07213-3Opioid-related disorders (D009293)Mobile applications (D063731)Opiate substitution treatment (D058850)Smartphone (D000068997)Behavioral therapy (D001521) |
| spellingShingle | Ronald G. Thompson Mary Bollinger Michael J. Mancino Deborah Hasin Xiaotong Han Keith A. Bush Clint D. Kilts G. Andrew James Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial Trials Opioid-related disorders (D009293) Mobile applications (D063731) Opiate substitution treatment (D058850) Smartphone (D000068997) Behavioral therapy (D001521) |
| title | Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial |
| title_full | Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial |
| title_fullStr | Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial |
| title_full_unstemmed | Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial |
| title_short | Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial |
| title_sort | smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder study protocol for a randomized controlled trial |
| topic | Opioid-related disorders (D009293) Mobile applications (D063731) Opiate substitution treatment (D058850) Smartphone (D000068997) Behavioral therapy (D001521) |
| url | https://doi.org/10.1186/s13063-023-07213-3 |
| work_keys_str_mv | AT ronaldgthompson smartphoneinterventiontooptimizemedicationassistedtreatmentoutcomesforopioidusedisorderstudyprotocolforarandomizedcontrolledtrial AT marybollinger smartphoneinterventiontooptimizemedicationassistedtreatmentoutcomesforopioidusedisorderstudyprotocolforarandomizedcontrolledtrial AT michaeljmancino smartphoneinterventiontooptimizemedicationassistedtreatmentoutcomesforopioidusedisorderstudyprotocolforarandomizedcontrolledtrial AT deborahhasin smartphoneinterventiontooptimizemedicationassistedtreatmentoutcomesforopioidusedisorderstudyprotocolforarandomizedcontrolledtrial AT xiaotonghan smartphoneinterventiontooptimizemedicationassistedtreatmentoutcomesforopioidusedisorderstudyprotocolforarandomizedcontrolledtrial AT keithabush smartphoneinterventiontooptimizemedicationassistedtreatmentoutcomesforopioidusedisorderstudyprotocolforarandomizedcontrolledtrial AT clintdkilts smartphoneinterventiontooptimizemedicationassistedtreatmentoutcomesforopioidusedisorderstudyprotocolforarandomizedcontrolledtrial AT gandrewjames smartphoneinterventiontooptimizemedicationassistedtreatmentoutcomesforopioidusedisorderstudyprotocolforarandomizedcontrolledtrial |