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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05515757
Other study ID # STUDY00023484
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 22, 2022
Est. completion date December 2024

Study information

Verified date May 2024
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 90
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mobile-app based contingency management
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.

Locations

Country Name City State
United States Linda Peng Portland Oregon

Sponsors (3)

Lead Sponsor Collaborator
Oregon Health and Science University Affect Therapeutics, Inc., CareOregon

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intervention acceptability and feasibility Evaluated using semi-structured qualitative interviews with participants and staff Week 0-8
Secondary 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. Week 0-8
Secondary 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. Week 0-8
Secondary 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. Week 0-8
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