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Completed

NCT Number: NCT04544124

Delivering Contingency Management in Outpatient Addiction Treatment

Methamphetamine misuse has become a growing concern in Alberta, creating a burden on the health care system. Further, individuals who use methamphetamine in Alberta exhibit significant difficulty remaining in treatment. These troubling patterns necessitate the provision of evidence-based practices (EBPs)-those grounded in empirical evidence-to ensure the best possible care and outcomes for those struggling with this addiction. Within the field of substance use (SU), contingency management (CM) is an extensively studied evidence-based treatment (EBT) for addictive disorders.

CM is an intervention that provides incentives to encourage positive behavioural change. Compared to standard care (treatment-as-usual (TAU)), CM has resulted in improvements in abstinence, attendance, adherence, retention, and quality of life. The efficacy of CM has largely been investigated in the context of reinforcing abstinence, though the literature suggests that CM which reinforces attendance may be as effective. Research from the US has examined the cost-effectiveness of CM and found that although CM costs more, it was associated with greater abstinence, treatment completion, and substance-absent urine compared to TAU. Despite the promising literature, the uptake of CM in Canada is limited making it difficult to understand whether this EBT is equally efficacious as compared to the US.

This study will implement and evaluate the efficacy of virtually delivered attendance-based CM in outpatient addiction treatment in Alberta. Participants (N=544) will be individuals seeking treatment for methamphetamine use (n=304) and individuals seeking treatment for substance use issues other than methamphetamine use (n=240). It is hypothesized that compared to participants in TAU, participants in CM will evidence: (1) greater retention, (2) greater attendance, (3) greater abstinence from methamphetamine and less methamphetamine use, (4) greater abstinence from other SU and less SU, and (5) greater improvement in quality of life over the intervention and follow-up periods. Exploratory aims include understanding how: outcomes differ based remote versus in-person delivery of CM; outcomes differ between participants who use methamphetamine and participants who use substances other than methamphetamine; the costs of CM differ from TAU; CM changes health service use.

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Key information

Conditions

Methamphetamine Adults Chemically-Induced Disorders Contingency Management Drug Abuse Drug Use Humans Mental Disorders Methamphetamine Abuse Methamphetamine-dependence Substance Abuse Substance Use Substance Use Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adult Addiction Services in Alberta Health Services, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-years of age or older
  • Seeking treatment for methamphetamine use or substance use issues other than methamphetamine use
  • Reported methamphetamine use or substance use other than methamphetamine use within 3-months prior to study entry
  • Deemed appropriate for treatment-as-usual using Alberta Health Services clinical procedures
  • Willing to participate in the 12-week intervention in-person or virtually at least once weekly
  • Willing to participate in-person or virtually for a follow-up at 3, 6, and 12-months following the 12-week intervention period
  • Willing to complete questionnaires weekly during the 12-week intervention period and at each follow-up at 3, 6, and 12-months following the 12-week intervention period

Exclusion criteria

  • Past or current history of gambling problems
  • Imminent plans to enter an environment in which participation in this study is restricted (e.g., residential treatment, inpatient unit, detoxification, incarceration, house arrest).
  • Attended more than one treatment session since their intake, or screening date was more than one month following their first day of treatment at the Alberta Health Services clinic
  • No plans to attend weekly treatment at the Alberta Health Services clinic

Treatment and study plan

Contingency Management

Behavioral

Incentives will be provided for treatment attendance over a 12-week period.

Primary outcomes

  1. Differences in Treatment Retention from Baseline to Post-Intervention at Week 12

    Time frame: Baseline to Post-Intervention at Week 12.

    The number of days between the first and last scheduled treatment session.

Secondary outcomes

  1. Proportion of Methamphetamine Abstinent Days Measured Using the Timeline Followback (TLFB) Questionnaire

    Time frame: Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).

    The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of methamphetamine will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.

  2. Longest Consecutive Days of Methamphetamine Abstinence Measured Using the Timeline Followback (TLFB) Questionnaire

    Time frame: Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).

    The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of methamphetamine will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.

  3. Longest Consecutive Days of Methamphetamine Use Measured Using the Timeline Followback (TLFB) Questionnaire

    Time frame: Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).

    The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of methamphetamine will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.

  4. Proportion of Days Abstinent from Other Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire

    Time frame: Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).

    The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.

  5. Longest Consecutive Days Abstinent from Other Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire

    Time frame: Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).

    The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.

  6. Longest Consecutive Days of Use of Other Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire

    Time frame: Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).

    The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.

  7. Mean Number of Units Consumed of Other Quantifiable Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire

    Time frame: Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).

    The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.

  8. Total Number of Units Consumed of Other Quantifiable Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire

    Time frame: Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).

    The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.

  9. Largest Number of Units Consumed of Other Quantifiable Licit and Illicit Substances in One Day Measured Using the Timeline Followback (TLFB) Questionnaire

    Time frame: Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).

    The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.

  10. Proportion of Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12

    Time frame: Baseline to Post-Intervention at Week 12.

    Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).

  11. Longest Consecutive Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12

    Time frame: Baseline to Post-Intervention at Week 12.

    Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).

  12. Longest Consecutive Days Absent from Scheduled Treatment from Baseline to Post-Intervention at Week 12

    Time frame: Baseline to Post-Intervention at Week 12.

    Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).

  13. Mean Number of Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12

    Time frame: Baseline to Post-Intervention at Week 12.

    Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).

  14. Total Number of Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12

    Time frame: Baseline to Post-Intervention at Week 12.

    Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).

Other outcomes

  1. Changes in Quality of Life Measured Using the 26-item World Health Organization (WHO) Quality of Life-BREF (WHOQOL-BREF)

    Time frame: Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).

    The WHOQOL-BREF is a 26-item self-report instrument that measures quality of life across four domains: physical health, psychological health, social relationships, and environment.

  2. Differences in Outcome Measures Between Remote and In-Person Delivery of Contingency Management

    Time frame: Baseline to Post-Intervention Week 12.

    To explore whether the pre-specified outcomes differ between participants who choose to attend their contingency management remotely and participants who choose to attend their contingency management in-person.

  3. Differences in Outcomes Between Participants Seeking Treatment for Methamphetamine Use and Participants Seeking Treatment for Substance Use Issues Other Than Methamphetamine Use

    Time frame: Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).

    To explore whether the pre-specified outcomes differ between participants who are seeking treatment for methamphetamine use and participants seeking treatment for substance use issues other than methamphetamine use.

  4. Differences in Costs Between Contingency Management and Treatment-As-Usual

    Time frame: Baseline to Post-Intervention Week 12.

    To explore differences in the costs of providing contingency management for treatment attendance and treatment-as-usual alone.

  5. Differences in Health Service Use Between Contingency Management and Treatment-As-Usual

    Time frame: Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).

    To explore differences in health service use between the experimental group which examines contingency management for treatment attendance and the treatment-as-usual alone group as measured by the number of (a) emergency department visits, (b) visits to urgent care centers, (c) hospitalizations, and (d) enrolments in other treatment services.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services

Registry information

Official study title

Expanding Capacity in Alberta to Deliver Contingency Patient Management in Outpatient Addiction Treatment: A Randomized Clinical Trial for Methamphetamine Use

Acronym: PRISE

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 10, 2020
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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