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
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
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
NCT ID
NCT05515757
First Posted
August 10, 2022
Last Updated
August 23, 2022
Sponsor
Oregon Health and Science University
Collaborators
CareOregon, Affect Therapeutics, Inc.
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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