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Delivering Contingency Management in Outpatient Addiction Treatment (PRISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04544124
Recruitment Status : Not yet recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
David Hodgins, University of Calgary

Brief Summary:

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. However, no direct comparisons of these two approaches exist, presenting an important gap in the literature as to whether these two forms of CM, which may substantially differ in cost, are equally as efficacious. 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 two CM programs in outpatient addiction treatment in Alberta for individuals seeking treatment for methamphetamine use. One CM program will reinforce attendance and another will reinforce methamphetamine abstinence. It is hypothesized that compared to participants in TAU, participants in CM will: (1) remain in treatment longer and (2) attend more treatment sessions over the intervention period, (3) maintain greater lengths of continuous and overall abstinence from methamphetamine, (4) evidence greater reductions in SU, (5) greater compliance in submitting urine samples, and (6) greater improvement in quality of life over the intervention and follow-up periods. Exploratory aims include understanding how: outcomes differ based on CM program; the costs of CM differ from TAU; CM changes health service use.


Condition or disease Intervention/treatment Phase
Methamphetamine Methamphetamine Abuse Methamphetamine-dependence Contingency Management Humans Adult Substance Use Substance Abuse Drug Use Drug Abuse Behavioral: Contingency management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will randomly be assigned to one of three treatment arms: contingency management which incentivizes participants for their treatment attendance, contingency management which incentivizes participants for their methamphetamine abstinence, and treatment-as-usual with no contingency management.
Masking: None (Open Label)
Masking Description: Given incentivization will occur for either attendance or abstinence, it is not possible to blind conditions.
Primary Purpose: Treatment
Official Title: Expanding Capacity in Alberta to Deliver Contingency Patient Management in Outpatient Addiction Treatment: A Randomized Clinical Trial for Methamphetamine Use
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
Experimental: Contingency management for treatment attendance
Participants who receive contingency management in addition to their usual care (treatment-as-usual). These participants are in the 12-week contingency management program which provides incentives for their treatment attendance.
Behavioral: Contingency management
Incentives will be provided for either treatment attendance or methamphetamine abstinence over a 12-week period.

Experimental: Contingency management for methamphetamine abstinence
Participants who receive contingency management in addition to their usual care (treatment-as-usual). These participants are in the 12-week contingency management program which provides incentives for their abstinence from methamphetamine.
Behavioral: Contingency management
Incentives will be provided for either treatment attendance or methamphetamine abstinence over a 12-week period.

No Intervention: Treatment-as-usual
Participants who solely receive their usual care (treatment-as-usual) and do not receive contingency management.



Primary Outcome Measures :
  1. Change in Treatment Retention from Baseline to Post-Intervention at Week 12 [ Time Frame: Baseline to Post-Intervention at Week 12. ]
    The number of weeks between the first and last scheduled treatment session.

  2. Longest Duration of Abstinence from Methamphetamine [ 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 number of methamphetamine-absent urine samples consecutively received during the intervention period and follow-up periods.


Secondary Outcome Measures :
  1. Reduction in the Use of Other Licit and Illicit Substances [ 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 decrease in the proportion of substances used over the intervention period and follow-up periods as measured by urine tests.

  2. Change in Treatment Attendance from Baseline to Post-Intervention at Week 12 [ Time Frame: Baseline to Post-Intervention at Week 12. ]
    The percentage of the scheduled treatments attended over the course of the 12-week intervention period.

  3. Compliance in Submitting Requested Urine Samples [ 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 percentage of requested urine samples submitted during the intervention period and follow-up periods.


Other Outcome Measures:
  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 Contingency Management for Treatment Attendance and Contingency Management for Methamphetamine Abstinence [ 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 the experimental group which examines contingency management for treatment attendance and the experimental group which examines contingency management for methamphetamine abstinence.

  3. 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, contingency management for methamphetamine abstinence, and treatment-as-usual alone.

  4. 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, the experimental group which examines contingency management for methamphetamine abstinence group, 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-years of age or older
  • Seeking treatment for methamphetamine use
  • Reported methamphetamine use within 3-months prior to study entry or within 3-months preceding the participant's exit from a controlled environment
  • Deemed appropriate for treatment-as-usual using Alberta Health Services clinical procedures
  • Willing to return to the Alberta Health Services site in-person at least once weekly to meet with the contingency management study assistant
  • Willing to complete questionnaires and provide a urine sample weekly
  • Willing to return to the Alberta Health Services site in-person for a follow-up at 3, 6, and 12-months following the 12-week intervention period

Exclusion Criteria:

  • Past or current history of gambling problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544124


Contacts
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Contact: Megan E Cowie, MSc 587-999-1153 megan.cowie@ucalgary.ca
Contact: David C Hodgins, PhD 403-220-3371 dhodgins@ucalgary.ca

Locations
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Canada, Alberta
Adult Addiction Services in Alberta Health Services
Calgary, Alberta, Canada, T2R 0B3
Contact: Jeffrey Danielson    403-367-5028    jeffrey.danielson@albertahealthservices.ca   
Addiction Services Edmonton in Alberta Health Services
Edmonton, Alberta, Canada, T5J 0G5
Contact: Tracey Marshall Craig    780-415-0046    Tracey.MarshallCraig@albertahealthservices.ca   
Sponsors and Collaborators
University of Calgary
Alberta Health Services
Investigators
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Principal Investigator: David C Hodgins, PhD University of Calgary
Publications:
Impacts of Methamphetamine Abuse in Canada: Hearing Before the House of Comm. Standing Committee on Health, 126 Report, 42nd Parliament, 1st Sess. (Nov. 29, 2018).
Dozois DJA, Mikail SF, Alden LE, Bieling PJ, Bourgon G, Clark DA, et al. The CPA presidential task force on evidence-based practice of psychological treatments. Canadian Psychology/Psychologie Canadienne. 2014;55(3):153-160.
Petry NM. Contingency management for substance abuse treatment: a guide for implementing this evidence-based practice. New York: Taylor & Francis Group; 2012.
CRISM-Alberta Health Services. Demographics and service utilization patterns of clients enrolled in specialty addiction treatment for amphetamine use, 2012-2018; Edmonton (Alberta): Canadian Research Initiative in Substance Misuse (CRISM); 2019 Jun. 22 p.

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Responsible Party: David Hodgins, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT04544124    
Other Study ID Numbers: 200443
2021-HQ-000013 ( Other Grant/Funding Number: Health Canada )
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Hodgins, University of Calgary:
Contingency Management
Methamphetamine
Treatment
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders