Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06211972 |
| Other study ID # |
1029238 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2024 |
| Est. completion date |
February 1, 2026 |
Study information
| Verified date |
February 2024 |
| Source |
Dalhousie University |
| Contact |
Sherry Stewart, PhD |
| Phone |
902-494-3793 |
| Email |
sstewart[@]dal.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The opioid crisis continues its devastating impact on Canada, with over 13,900 deaths
recorded between 2016 and 2019. Dangerous prescription opioid usage persists, affecting 12.3%
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 OpiVenture's
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 program's 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.
Description:
The opioid crisis continues to devastate individuals, families, and communities across
Canada. In 2016-19, more than 13,900 opioid-related deaths occurred in Canada. Dangerous
patterns of prescription opioid use (e.g., 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 12.3% of Canadians in 2018. Non-medical use of prescription
opioids is markedly higher in Canada/US than elsewhere in the world. Prescription opioids
pose an addiction risk of ~5.5% and cost Canadians ~$3.5 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
(e.g., heroin, cocaine) are also increasingly being cut with the cheaper fentanyl, leading to
a surge in accidental overdoses. Only 0.08% of seized heroin samples tested positive for
fentanyl in 2012, whereas 60.1% 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 buprenorphine/naloxone 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, anxiolytic/sedative, stimulant (cocaine/amphetamines), 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 sedative/anxiolytic), 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,
27.5% 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 (e.g., 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 (i.e., externalizing) and inhibited (i.e., 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; novelty/pleasure 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 OpiVenture's
development is the U.S. National Institute of Health's (NIH's) 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 (e.g., 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.
