Hospital-Based Contingency Management

Amphetamine-Related Disorders Clinical Trial

Official title:

Development of a Hospital-Based Contingency Management Intervention

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05515757
• Other study ID #: STUDY00023484
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Amphetamine-Related Disorders

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