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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDalhousie University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

96 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, one-month follow up, and four-month follow up
2

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

Time frame
Baseline, one-month follow up, and four-month follow up

Secondary outcomes

1

Changes in mental health of study participants

Using the 21-item Depression, Anxiety and Stress Scale (DASS-21), we will measure changes in depression, anxiety and stress over time. The DASS-21 is the short form of the DASS-42, a self-report scale designed to measure the negative emotional states of depression, anxiety and stress. The minimum and maximum values for each subscale are as follows: depression (0-21), anxiety (0-21), and stress (0-21). Higher scores indicate greater severity of symptoms.

Time frame
Baseline, one-month follow up, and four-month follow up
2

The risky, impulsive, and self-destructive behaviors

To measures risky, impulsive, and self-destructive behaviors, we will use the 38-item The Risky, Impulsive, \& Self-destructive behavior Questionnaire (RISQ). The RISQ is a self-report questionnaire that assesses a wide range of behaviors, including substance use, aggression, and self-harm. The scale has a minimum score of 0 and a maximum score of 114, with higher scores indicating more risky, impulsive, and self-destructive behaviors.

Time frame
Baseline, one-month follow up, and four-month follow up
3

Motives for substance use questionnaire

To measure clients' motives for substance, we will use the Substance Use Motives Measure (SUMM). The SUMM is an eight-factor model that identifies eight motives for alcohol and substance use: Enhancement, Social, Conformity, Anxiety-Coping, Depression-Coping, Boredom-Coping, Self expansion, and Performance. Higher scores on the SUMM indicate a greater endorsement of the motives for substance use.

Time frame
Baseline, one-month follow up, and four-month follow up
4

Participants' changes in subjective pain

Subjective pain will be measured by Short Form McGill Pain Questionnaire II (SF-MPQ-II) and enhanced Chronic Pain Questionnaire (eCPQ) . The SF-MPQ-II is a shorter version of the original McGill Pain Questionnaire (MPQ) and assesses the major symptoms of both neuropathic and non-neuropathic pain. It includes 22 items with 0-10 numerical response options. Higher scores on the SF-MPQ-II indicate a greater intensity of pain, while higher scores on the eCPQ indicate a greater impact of chronic pain on an individual's life

Time frame
Baseline, one-month follow up, and four-month follow up

Other outcomes

1

Socio-Demographic Questionnaire.

We will collect sociodemographic data including age, sex, gender identity, ethnicity, socio-economic status, living circumstances, relationship status, education and Opioid Agonist Therapy history including current type of Opioid Agonist Therapy and dose, clinic, pain

Time frame
At baseline
2

Personality Traits

Personality will be assessed with the reliable and valid 23-item Substance Use Risk Profile Scale (SURPS). The SURPS has 4 subscales which each tap one personality factor in the 4-factor model . Comparisons of respondents' scores on these measures relative to norms will be used for selection into OpiVenture and for assignment to a specific intervention (i.e., Anxiety Sensitivity, Hopelessness, impulsivity, or Sensation-seeking).Higher scores on the SURPS subscales indicate a higher likelihood of substance use.

Time frame
At baseline

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dalhousie University

Lead sponsor

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

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