The Feasibility of the OpiVenture Program for Clients Undergoing Opioid Agonist Therapy

NCT06211972 | Not Yet Recruiting

• 1 other identifier: 1029238
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Opioid Use Disorder; Polysubstance Addiction; Substance Use

Keywords

Anxiety sensitivity; Hopelessness; Sensation-seeking; Impulsivity; Personality; Psychosocial Interventions; Feasibility; Opioid Agonist Therapy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

Other Outcomes (2)

• Socio-Demographic Questionnaire.

  At baseline

• Personality Traits

  At baseline

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: OpiVenture

Interventions

OpiVenture BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently enrolled in Opioid Agonist Therapy at one of the 4 partner clinics in Quebec and Atlantic Canada for 30 days
• ≥18 years of age Score at least one standard deviation (SD) above the population-specific norm on 1 of 4 personality traits on the Substance Use Risk Profile Scale (SURPS ) Ability to understand spoken English or French Ability to provide informed consent

You may not qualify if:

• Those who are unable to provide informed consent and indicate severe cognitive impairment -measured by the Mini-Mental State Examination (MMSE), will be excluded.

Sponsors & Collaborators

• Dalhousie University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Direction 180 | Nova Scotia Mental Health and Addictions: collaborator
• Centre for Research, Education, and Clinical Care of At-Risk Populations (RECAP): collaborator
• River Stone Recovery Centre: collaborator
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator
• Université de Montréal: collaborator
• University of New Brunswick: collaborator

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders; Impulsive Behavior

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Sherry Stewart, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherry Stewart, PhD

CONTACT

902-494-3793; sstewart@dal.ca

Neda Alizadeh, PhD

CONTACT

neda.alizadeh@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: As there is single group on this study, there is no randomization and masking.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A mixed-methods approach nested in a pre-to-post follow-up design

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 18, 2024
• Study Start: October 15, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share