Personality-Targeted Interventions for Addressing Polysubstance Use Among Opioid-Addicted Clients Undergoing Opioid Agonist Therapy: A Feasibility Study
Sponsor study identifier
interventional
96
0 countries
N/A
Study Start
October 15, 2024
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Primary Completion
February 1, 2025
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Study Completion
February 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2026
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 11, 2023
Actual (reported)January 18, 2024
Actual (reported)October 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 1, 2025
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February 1, 2026
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Number of substance-using days
This outcome will be measured by self-report data collected via timeline-follow back (TLFB) assessment which uses a calendar to examine substance use in detail for each day in the past 30, starting with the most recent event
Baseline, one-month follow up, and four-month follow up
Retention of participants in the Opioid Agonist Therapy Program
If a client is not available for a 1- or 4-month follow-up assessment, we will check with the clinic's database to determine if this client is still receiving OAT services at the clinic. If they are no longer receiving OAT services, they will be defined as an OAT dropout for the purposes of retention analyses
Baseline, one-month follow up, and four-month follow up
In this study, there is only one study arm, and all eligible participants will be assigned to a treatment group and will participate in three treatment sessions of the OpiVenture program, in addition to the Opioid therapy agonist treatment they are receiving through the recruiting clinic.
OpiVenture, a targeted psychosocial intervention, complements opioid agonist therapy for opioid use disorder. Adapted from proven interventions like PreVenture, it unfolds over three sessions. Session one covers introductions, an ice-breaker, trait overview, strengths/limitations discussion, goal setting, and homework. Session two reviews homework, explores coping strategies, weighs alternatives, introduces "hot thoughts," reviews trait-specific hot thoughts, and assigns homework. The concluding session involves reviewing homework, identifying personal hot thoughts, challenging them through a cognitive-behavioral exercise, applying insights to goal setting, and concluding with a wrap-up.
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Sherry Stewart, PhD
Dalhousie University
First Submitted
December 11, 2023
First Posted
January 18, 2024
Study Start
October 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Women's Opioid Treatment Follow-up Study
Changes in mental health of study participants
Baseline, one-month follow up, and four-month follow up
The risky, impulsive, and self-destructive behaviors
Baseline, one-month follow up, and four-month follow up
Motives for substance use questionnaire
Baseline, one-month follow up, and four-month follow up
Participants' changes in subjective pain
Baseline, one-month follow up, and four-month follow up
Participants' changes in subjective pain
Baseline, one-month follow up, and four-month follow up
Socio-Demographic Questionnaire.
At baseline
Personality Traits
At baseline
Contact the study team to confirm eligibility.
Primary Completion
February 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 30, 2024
Record last verified: 2024-07
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