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Hospital-Based Contingency Management

Primary Purpose

Amphetamine-Related Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile-app based contingency management
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amphetamine-Related Disorders focused on measuring Amphetamine-Related Disorders, substance-related disorders, behavior therapy, psychology reinforcement, hospital medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Be 18 years of age or older
  • Have moderate to severe stimulant use disorder, as diagnosed using DSM-5 criteria for stimulant use disorder by an addiction medicine provider
  • Have an anticipated hospital length of stay greater than 2 weeks
  • Be able to use a smartphone and agree to download and use the Affect app as part of study-related procedures
  • Be English speaking and be able to understand explanations of study procedures and the informed consent to participate

Exclusion Criteria:

  • Unable to engage in the intervention due to cognitive impairment or altered mental status
  • Unable to engage in the intervention due to acute medical/mental health issues, per judgement of the research assistant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Mobile app-based contingency management

    Arm Description

    All participants will be enrolled into an 8-week mobile app-based contingency management intervention starting during a prolonged hospitalization.

    Outcomes

    Primary Outcome Measures

    Intervention acceptability and feasibility
    Evaluated using semi-structured qualitative interviews with participants and staff

    Secondary Outcome Measures

    Brief Addiction Monitor (BAM)
    The Brief Addiction Monitor (BAM) is a 17-item, multidimensional, progress-monitoring instrument for patients with a substance use disorder. The BAM includes items that assess risk factors for substance use, protective factors that support recovery, and drug and alcohol use. This instrument will be used to monitor the progress of the participants substance use disorder. Each functional domain of the survey (use, risk, protective) has an associated composite score which serves as a marker of clinical status. For Use (Scores 0 to 12), higher scores mean more substance use. For Risk (scores 0 to 24), higher sores mean more risk. For Protective (scores 0 to 24), higher scores mean more protection.
    Participant engagement in the contingency management intervention
    Participation in the contingency management intervention will be tracked. This includes number of counseling appointments attended and number of self-reflection activities attended. This is an implementation outcome where we measure how often participants are engaging in this intervention.
    Participant drug test results
    Participants can complete twice weekly drug testing as part of the contingency management intervention. We will measure the number of positive and negative drug tests as an objective measure of substance use.

    Full Information

    First Posted
    August 10, 2022
    Last Updated
    August 23, 2022
    Sponsor
    Oregon Health and Science University
    Collaborators
    CareOregon, Affect Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05515757
    Brief Title
    Hospital-Based Contingency Management
    Official Title
    Development of a Hospital-Based Contingency Management Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 22, 2022 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Oregon Health and Science University
    Collaborators
    CareOregon, Affect Therapeutics, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study aims to adapt an outpatient mobile app-based contingency management intervention to the hospital setting to understand how we can use contingency management to improve health outcomes in hospitalized patients with stimulant use disorders.
    Detailed Description
    Contingency management (CM), an evidence-based strategy that utilizes a reward-based system as positive reinforcement, has been most robustly studied in the outpatient setting, but also has the potential to improve hospital care for patients with stimulant use disorder. The hospital is a challenging environment for people who use drugs. Conflicts with staff often result from in-hospital substance use, prolonged time off the unit, and missing medications, leading to negative health outcomes and re-admissions. By relying on positive rewards to encourage positive health behaviors, CM has the potential to improve staff-patient relationships, healthcare engagement, and reduce substance use in the hospital. Stimulant use disorder is especially difficult to address in the hospital due to a lack of medications that can support cravings and withdrawal symptoms. However, little is known about CM implementation in hospitals and the hospital setting may introduce unique challenges. The objective of this study is to adapt an outpatient mobile app-based CM intervention to the hospital setting to understand the feasibility and acceptability of a hospital-based CM intervention to improve health outcomes in hospitalized patients with substance use disorders. We'll achieve this objective through following specific aims: Aim 1: Identify adaptations needed to implement an evidence-based outpatient mobile-app based CM intervention to the hospital setting for hospitalized patients with substance use disorders. Aim 2: Determine the feasibility, including facilitators and barriers, of implementing a mobile app-based CM intervention in the hospital setting. Aim 3: Assess the acceptability of a mobile app-based hospital-based CM intervention to patients and staff.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amphetamine-Related Disorders
    Keywords
    Amphetamine-Related Disorders, substance-related disorders, behavior therapy, psychology reinforcement, hospital medicine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mobile app-based contingency management
    Arm Type
    Other
    Arm Description
    All participants will be enrolled into an 8-week mobile app-based contingency management intervention starting during a prolonged hospitalization.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mobile-app based contingency management
    Intervention Description
    We are adapting an evidence-based outpatient mobile-app based CM intervention to the hospital setting for hospitalized patients with stimulant use disorders requiring prolonged hospitalization. Participants will be enrolled into an 8-week mobile-app based contingency management intervention.
    Primary Outcome Measure Information:
    Title
    Intervention acceptability and feasibility
    Description
    Evaluated using semi-structured qualitative interviews with participants and staff
    Time Frame
    Week 0-8
    Secondary Outcome Measure Information:
    Title
    Brief Addiction Monitor (BAM)
    Description
    The Brief Addiction Monitor (BAM) is a 17-item, multidimensional, progress-monitoring instrument for patients with a substance use disorder. The BAM includes items that assess risk factors for substance use, protective factors that support recovery, and drug and alcohol use. This instrument will be used to monitor the progress of the participants substance use disorder. Each functional domain of the survey (use, risk, protective) has an associated composite score which serves as a marker of clinical status. For Use (Scores 0 to 12), higher scores mean more substance use. For Risk (scores 0 to 24), higher sores mean more risk. For Protective (scores 0 to 24), higher scores mean more protection.
    Time Frame
    Week 0-8
    Title
    Participant engagement in the contingency management intervention
    Description
    Participation in the contingency management intervention will be tracked. This includes number of counseling appointments attended and number of self-reflection activities attended. This is an implementation outcome where we measure how often participants are engaging in this intervention.
    Time Frame
    Week 0-8
    Title
    Participant drug test results
    Description
    Participants can complete twice weekly drug testing as part of the contingency management intervention. We will measure the number of positive and negative drug tests as an objective measure of substance use.
    Time Frame
    Week 0-8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Be 18 years of age or older Have moderate to severe stimulant use disorder, as diagnosed using DSM-5 criteria for stimulant use disorder by an addiction medicine provider Have an anticipated hospital length of stay greater than 2 weeks Be able to use a smartphone and agree to download and use the Affect app as part of study-related procedures Be English speaking and be able to understand explanations of study procedures and the informed consent to participate Exclusion Criteria: Unable to engage in the intervention due to cognitive impairment or altered mental status Unable to engage in the intervention due to acute medical/mental health issues, per judgement of the research assistant
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Linda Peng, MD
    Phone
    8054059761
    Email
    pengli@ohsu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Hospital-Based Contingency Management

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