Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06211972
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-15
First Post:
2023-12-11
Brief Title:
The Feasibility of the OpiVenture Program for Clients Undergoing Opioid Agonist Therapy
Sponsor:
Dalhousie University
Organization:
Dalhousie University
Study Overview
Official Title:
Personality-Targeted Interventions for Addressing Polysubstance Use Among Opioid-Addicted Clients Undergoing Opioid Agonist Therapy A Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The opioid crisis continues its devastating impact on Canada with over 13900 deaths recorded between 2016 and 2019 Dangerous prescription opioid usage persists affecting 123 of Canadians in 2018 The crisis has escalated particularly during the COVID-19 pandemic resulting in increased mortality rates While opioid agonist therapy OAT is a common treatment it falls short in addressing concurrent polysubstance use a prevalent issue in OAT clients Recognizing the limitations of OAT alone there is a growing recommendation to supplement it with psychosocial interventions
The PreVenture program known for its efficacy in reducing substance use has been adapted for OAT clients termed OpiVenture This study aims to comprehensively assess OpiVentures feasibility and limited efficacy within an OAT setting Utilizing a mixed-methods approach the study design integrates qualitative and quantitative data collection methods to thoroughly evaluate the programs feasibility and preliminary effectiveness The focus extends beyond immediate outcomes encompassing the preparation for future randomized controlled trials including considerations for sample size calculation and recruitment effectiveness This research addresses the urgent need for more comprehensive interventions to mitigate opioid use disorder OUD and associated morbidity offering a potential solution to improve OAT retention and reduce mortality rates
The PreVenture program known for its efficacy in reducing substance use has been adapted for OAT clients termed OpiVenture This study aims to comprehensively assess OpiVentures feasibility and limited efficacy within an OAT setting Utilizing a mixed-methods approach the study design integrates qualitative and quantitative data collection methods to thoroughly evaluate the programs feasibility and preliminary effectiveness The focus extends beyond immediate outcomes encompassing the preparation for future randomized controlled trials including considerations for sample size calculation and recruitment effectiveness This research addresses the urgent need for more comprehensive interventions to mitigate opioid use disorder OUD and associated morbidity offering a potential solution to improve OAT retention and reduce mortality rates
Detailed Description:
The opioid crisis continues to devastate individuals families and communities across Canada In 2016-19 more than 13900 opioid-related deaths occurred in Canada Dangerous patterns of prescription opioid use eg using a prescribed opioid without a prescription outside of its intended purposes or in excessive quantities remain a major health threat Opioids were prescribed to 123 of Canadians in 2018 Non-medical use of prescription opioids is markedly higher in CanadaUS than elsewhere in the world Prescription opioids pose an addiction risk of 55 and cost Canadians 35 billion in healthcare productivity and justice costs pre-pandemic They also pose a threat through the danger of death by overdose Rates of hospitalization due to opioid poisoning have increased by 27 in the past 5 years signaling a worsening of the crisis Opioid-related mortality had been on a steady rise reaching epidemic proportions pre-pandemic Overdose rates have increased 5-fold over the past 20 years Opioid-related deaths have only increased since the COVID-19 pandemic due to the economic downturn and to disruptions to the drug supply chain through border closures This has resulted in the use of cheaper and more dangerous substances like the powerful synthetic opioids fentanyl and carfentanyl Pre-pandemic data link fentanyl with 72 of accidental opioid-related deaths in Canada an 81 increase from the year prior Street drugs eg heroin cocaine are also increasingly being cut with the cheaper fentanyl leading to a surge in accidental overdoses Only 008 of seized heroin samples tested positive for fentanyl in 2012 whereas 601 tested positive in 2017 - an enormous increase in 5 years Given the progression and escalation of the opioid crisis opioid use disorder OUD is now one of the greatest challenges facing the Canadian health care system compounded by the COVID-19 pandemic
Treatment for OUD generally involves pharmacological treatments such as opioid agonist therapy OAT including buprenorphine-naloxone and methadone both of which are efficacious in treating OUD and widely used in Canada Rooted in a harm-reduction approach those undergoing OAT are administered a synthetic opioid agonist under specific controlled dosages After stabilization both methadone and buprenorphinenaloxone have shown efficacy for suppressing opioid use with higher doses being more effective More recently alternative OAT treatment modalities including slow-release oral morphine Kadian and injectable opioid agonist therapy iOAT have been approved for use in opioid addiction medicine within Canada OAT is effective at reducing opioid use overdoses HIV risk and criminality
Limitations of OAT Unfortunately OAT alone fails to address other problems common in those with OUD Clients on OAT frequently present with concurrent use of numerous drugs and with high rates of comorbid alcohol anxiolyticsedative stimulant cocaineamphetamines and cannabis use disorders As a harm reduction treatment OAT reduces opioid use but it does not eliminate all opioid use in all OUD clients OAT clients polysubstance use includes risky drug combinations such as opioids including methadone plus benzodiazepines BZs a class of sedativeanxiolytic which greatly increases overdose risk and interferes with optimal treatment outcomes Experts recommend avoiding concurrent BZ-opioid prescriptions as one of the main ways to combat the opioid crisis Some individuals in OAT also continue frequently using other drugs such as alcohol cannabis and cocaine including via injection - a particularly risky administration route Co-use of alcohol and methadone increases overdose risk and negatively impacts cognitive performance and daily functioning While findings are mixed recent studies caution that concurrent cannabis use predicts poorer OAT response Stimulant co-use predicts HIV risk stimulants are often injected and poorer OAT retention Previous research in three studies 60-138 clients per study at six clinics across Nova Scotia New Brunswick Quebec highlight the very high rates of polysubstance use in OAT clients A consistent finding was the very high endorsement of recent polysubstance use while clients were on OAT 29 topped up their OAT with another opioid 275 injected drugs and 54 used BZs despite their well-documented overdose risk with OAT While OAT has had positive harm reduction effects for OUD adjunct psychosocial approaches may curb polysubstance use increase OAT retention and reduce overdose providing new solutions to the opioid crisis
Psychosocial Treatments Supplementing OAT Psychosocial treatments for substance use disorder SUD employ many techniques including contingency management relapse prevention cognitive behavior therapy CBT motivational interviewing and 12-step facilitation A recent systematic review showed supplementing OAT with psychosocial interventions led to greater treatment attendance psychological functioning and adherence to psychiatric medications and decreased opioid use alcohol use and HIV risk Recent Canadian guidelines for managing OUD released by Canadian Research Initiative on Substance Misuse CRISM network strongly endorse adding psychosocial treatment options to pharmacological interventions and advocate exploring additional non-pharmacotherapy interventions to supplement OAT The Opioid Task force of the Canadian Psychological Association recently made similar recommendations and called for increased research in this area to fill important gaps in knowledge around psychosocial and harm reduction interventions that work well in combination with OAT Despite the availability of psychosocial treatments to supplement OAT rates of concurrent polysubstance use remain exceedingly high among OAT clients OAT clinics feel unprepared to deal with complex psychiatric comorbidity and the effective psychosocial interventions require training backgrounds that are not often practical in OAT clinics eg minimum Masters degree in a mental health field to practice CBT Interventions that specifically and effectively target concurrent polysubstance use and psychiatric comorbidity are needed to improve OAT retention particularly those that are developed using a patient-oriented approach to increase their acceptability to patients and are practical for application by OAT service providers to ensure their sustainability in clinics
Personality Model of Substance Use Intervention Development An efficacious and effective protocoled psychosocial intervention for targeting polysubstance use over the past few decades has been developed and is adaptable to the OAT context providing a possible avenue for additional acceptable and sustainable psychosocial treatment that effectively targets clients dangerous concurrent polysubstance use to improve OAT retention The personality model of substance use posits that individual differences in substance use patterns are explained by differential sensitivity to the reinforcing effects of alcohol and other drugs based on functionally distinct motivational systems that are manifested as different traits Substance use behaviors can therefore be understood through two broad domains of personality - the disinhibited ie externalizing and inhibited ie internalizing domains - which in turn can be broken down into four lower-order personality traits that are intimately linked with substance use Elevations on these four personality traits have been shown to predict risk for using specific substances differential motivational profiles for substance use differential sensitivity to the pharmacological effects of various drugs and vulnerability to co-morbid psychiatric disorders
Using a combination of motivational enhancement and cognitive-behavioral skills-building via in-session group activities and homework these interventions target specific personality-relevant cognitive distortions see below and have been repeatedly shown to delay or reduce alcohol and other substance use by 30-80 among high-risk youth
Within the disinhibited domain lower-order personality traits associated with substance use are sensation seeking SS noveltypleasure seeking and impulsivity IMP disinhibited personality Within the inhibited domain lower-order traits associated with substance use are anxiety sensitivity AS fear of arousal and hopelessness HOP depression proneness These traits can be quickly measured with the widely validated and internationally used Substance Use Risk Profile Scale SURPS Within the four-factor model of substance use sensation seeking is characterized by a preference for novel and exciting activities and by boredom proneness
A Framework for Validation Intervention Adaptation and Testing Due to the clear need for more effective psychosocial interventions to supplement OAT for addressing OUD and related morbidity the ongoing high rates of polysubstance use among OAT clients and extremely high rates of OAT dropout PreVenture and CoVenture has been adapted to OUD clients in the OAT clinic context and is being called OpiVenture The framework underlying OpiVentures development is the US National Institute of Healths NIHs ORBIT model for psychosocial and behavioral treatment development This evidence-based framework centers around a stakeholder-informed significant clinical research question How can dangerous patterns of polysubstance use be curbed and how can OAT retention improve to reduce morbidity and mortality The ORBIT model provides guidance through four phases for improving the systematic development adaptation and testing of appropriately designed and innovative psychosocial interventions In Phase I the intervention is designed based on evidence from basic behavioral and psychosocial research and stakeholder input In Phase II preliminary testing of the intervention takes place eg feasibility studies It is only after Phases I-II that one proceeds on to Phases III-IV Efficacy RCTs and Effectiveness trials under real world conditions returning to earlier phases for refinement as necessary A patient-oriented integrated knowledge translation iKT approach is embedded throughout to ensure that developed interventions are acceptable to patients and practitioners
Phase I of OpiVenture development has been completed investigating the role of personality in the maintenance of substance use among OAT clients validating the four-factor personality model in this client demographic Using qualitative interview data focused on clients understanding of their personality substance use patterns contexts and triggers for their substance use has informed the adaptation of existing personality-targeted intervention manuals Additionally focus groups with OAT clinic service providers and staff informed intervention delivery format including ideal contextual parameters such as scenarios and session lengths
Treatment for OUD generally involves pharmacological treatments such as opioid agonist therapy OAT including buprenorphine-naloxone and methadone both of which are efficacious in treating OUD and widely used in Canada Rooted in a harm-reduction approach those undergoing OAT are administered a synthetic opioid agonist under specific controlled dosages After stabilization both methadone and buprenorphinenaloxone have shown efficacy for suppressing opioid use with higher doses being more effective More recently alternative OAT treatment modalities including slow-release oral morphine Kadian and injectable opioid agonist therapy iOAT have been approved for use in opioid addiction medicine within Canada OAT is effective at reducing opioid use overdoses HIV risk and criminality
Limitations of OAT Unfortunately OAT alone fails to address other problems common in those with OUD Clients on OAT frequently present with concurrent use of numerous drugs and with high rates of comorbid alcohol anxiolyticsedative stimulant cocaineamphetamines and cannabis use disorders As a harm reduction treatment OAT reduces opioid use but it does not eliminate all opioid use in all OUD clients OAT clients polysubstance use includes risky drug combinations such as opioids including methadone plus benzodiazepines BZs a class of sedativeanxiolytic which greatly increases overdose risk and interferes with optimal treatment outcomes Experts recommend avoiding concurrent BZ-opioid prescriptions as one of the main ways to combat the opioid crisis Some individuals in OAT also continue frequently using other drugs such as alcohol cannabis and cocaine including via injection - a particularly risky administration route Co-use of alcohol and methadone increases overdose risk and negatively impacts cognitive performance and daily functioning While findings are mixed recent studies caution that concurrent cannabis use predicts poorer OAT response Stimulant co-use predicts HIV risk stimulants are often injected and poorer OAT retention Previous research in three studies 60-138 clients per study at six clinics across Nova Scotia New Brunswick Quebec highlight the very high rates of polysubstance use in OAT clients A consistent finding was the very high endorsement of recent polysubstance use while clients were on OAT 29 topped up their OAT with another opioid 275 injected drugs and 54 used BZs despite their well-documented overdose risk with OAT While OAT has had positive harm reduction effects for OUD adjunct psychosocial approaches may curb polysubstance use increase OAT retention and reduce overdose providing new solutions to the opioid crisis
Psychosocial Treatments Supplementing OAT Psychosocial treatments for substance use disorder SUD employ many techniques including contingency management relapse prevention cognitive behavior therapy CBT motivational interviewing and 12-step facilitation A recent systematic review showed supplementing OAT with psychosocial interventions led to greater treatment attendance psychological functioning and adherence to psychiatric medications and decreased opioid use alcohol use and HIV risk Recent Canadian guidelines for managing OUD released by Canadian Research Initiative on Substance Misuse CRISM network strongly endorse adding psychosocial treatment options to pharmacological interventions and advocate exploring additional non-pharmacotherapy interventions to supplement OAT The Opioid Task force of the Canadian Psychological Association recently made similar recommendations and called for increased research in this area to fill important gaps in knowledge around psychosocial and harm reduction interventions that work well in combination with OAT Despite the availability of psychosocial treatments to supplement OAT rates of concurrent polysubstance use remain exceedingly high among OAT clients OAT clinics feel unprepared to deal with complex psychiatric comorbidity and the effective psychosocial interventions require training backgrounds that are not often practical in OAT clinics eg minimum Masters degree in a mental health field to practice CBT Interventions that specifically and effectively target concurrent polysubstance use and psychiatric comorbidity are needed to improve OAT retention particularly those that are developed using a patient-oriented approach to increase their acceptability to patients and are practical for application by OAT service providers to ensure their sustainability in clinics
Personality Model of Substance Use Intervention Development An efficacious and effective protocoled psychosocial intervention for targeting polysubstance use over the past few decades has been developed and is adaptable to the OAT context providing a possible avenue for additional acceptable and sustainable psychosocial treatment that effectively targets clients dangerous concurrent polysubstance use to improve OAT retention The personality model of substance use posits that individual differences in substance use patterns are explained by differential sensitivity to the reinforcing effects of alcohol and other drugs based on functionally distinct motivational systems that are manifested as different traits Substance use behaviors can therefore be understood through two broad domains of personality - the disinhibited ie externalizing and inhibited ie internalizing domains - which in turn can be broken down into four lower-order personality traits that are intimately linked with substance use Elevations on these four personality traits have been shown to predict risk for using specific substances differential motivational profiles for substance use differential sensitivity to the pharmacological effects of various drugs and vulnerability to co-morbid psychiatric disorders
Using a combination of motivational enhancement and cognitive-behavioral skills-building via in-session group activities and homework these interventions target specific personality-relevant cognitive distortions see below and have been repeatedly shown to delay or reduce alcohol and other substance use by 30-80 among high-risk youth
Within the disinhibited domain lower-order personality traits associated with substance use are sensation seeking SS noveltypleasure seeking and impulsivity IMP disinhibited personality Within the inhibited domain lower-order traits associated with substance use are anxiety sensitivity AS fear of arousal and hopelessness HOP depression proneness These traits can be quickly measured with the widely validated and internationally used Substance Use Risk Profile Scale SURPS Within the four-factor model of substance use sensation seeking is characterized by a preference for novel and exciting activities and by boredom proneness
A Framework for Validation Intervention Adaptation and Testing Due to the clear need for more effective psychosocial interventions to supplement OAT for addressing OUD and related morbidity the ongoing high rates of polysubstance use among OAT clients and extremely high rates of OAT dropout PreVenture and CoVenture has been adapted to OUD clients in the OAT clinic context and is being called OpiVenture The framework underlying OpiVentures development is the US National Institute of Healths NIHs ORBIT model for psychosocial and behavioral treatment development This evidence-based framework centers around a stakeholder-informed significant clinical research question How can dangerous patterns of polysubstance use be curbed and how can OAT retention improve to reduce morbidity and mortality The ORBIT model provides guidance through four phases for improving the systematic development adaptation and testing of appropriately designed and innovative psychosocial interventions In Phase I the intervention is designed based on evidence from basic behavioral and psychosocial research and stakeholder input In Phase II preliminary testing of the intervention takes place eg feasibility studies It is only after Phases I-II that one proceeds on to Phases III-IV Efficacy RCTs and Effectiveness trials under real world conditions returning to earlier phases for refinement as necessary A patient-oriented integrated knowledge translation iKT approach is embedded throughout to ensure that developed interventions are acceptable to patients and practitioners
Phase I of OpiVenture development has been completed investigating the role of personality in the maintenance of substance use among OAT clients validating the four-factor personality model in this client demographic Using qualitative interview data focused on clients understanding of their personality substance use patterns contexts and triggers for their substance use has informed the adaptation of existing personality-targeted intervention manuals Additionally focus groups with OAT clinic service providers and staff informed intervention delivery format including ideal contextual parameters such as scenarios and session lengths
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None