Amphetamine-Related DisordersNCT05515757
Hospital-Based Contingency Management
A study testing Mobile-app based contingency management in people with Amphetamine-Related Disorders, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amphetamine-Related Disorders
- What is being tested?
- Mobile-app based contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Hospital-Based Contingency Management Intervention
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.
Read the 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.
- Conditions
- Amphetamine-Related Disorders
- Being tested
- Mobile-app based contingency management
- Keywords
- Amphetamine-Related Disorders, substance-related disorders, behavior therapy, psychology reinforcement, hospital medicine
- Medical subject headings
- Amphetamine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile-app based contingency managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile app-based contingency management | Other | All participants will be enrolled into an 8-week mobile app-based contingency management intervention starting during a prolonged hospitalization. Receives: Behavioral: Mobile-app based contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention acceptability and feasibility
Evaluated using semi-structured qualitative interviews with participants and staff
Measured: Week 0-8
Secondary outcomes (3)
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.
Measured: Week 0-8
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.
Measured: Week 0-8
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.
Measured: Week 0-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start22 Aug 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amphetamine-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- CareOregon, Affect Therapeutics, Inc.
- Responsible party
- Principal investigator, Linda Peng, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515757
- Sponsor's protocol ID
- STUDY00023484
- Status last verified
- May 2024
- First submitted
- 10 Aug 2022
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peng L, Young K, Titus H, Peeples J, Song E, DeFrancesco C, Roellich P, Phillips R, Englander H. Supporting Patients With Stimulant Use Disorder During and After Hospitalization With a Mobile App-based Contingency Management Intervention: A Feasibility and Acceptability Study. J Addict Med. 2025 Nov 25:10.1097/ADM.0000000000001621. doi: 10.1097/ADM.0000000000001621. Online ahead of print.
PubMed 41287143
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Hospital-Based Contingency Management Intervention
- ClinicalTrials.gov ID
- NCT05515757
- Acronym / sponsor ID
- STUDY00023484
- Conditions
- Amphetamine-Related Disorders
- Keywords
- Amphetamine-Related Disorders, substance-related disorders, behavior therapy, psychology reinforcement, hospital medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- CareOregon, Affect Therapeutics, Inc.
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile app-based contingency management | Other | Behavioral: Mobile-app based contingency managementAll participants will be enrolled into an 8-week mobile app-based contingency management intervention starting during a prolonged hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile-app based contingency managementWe 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. | Behavioural | Mobile app-based contingency management |
Primary outcome
Intervention acceptability and feasibility
Time frame: Week 0-8
Evaluated using semi-structured qualitative interviews with participants and staff
3 secondary outcomes
Brief Addiction Monitor (BAM)
Time frame: Week 0-8
Participant engagement in the contingency management intervention
Time frame: Week 0-8
Participant drug test results
Time frame: Week 0-8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 41287143Peng L, Young K, Titus H, Peeples J, Song E, DeFrancesco C, Roellich P, Phillips R, Englander H. Supporting Patients With Stimulant Use Disorder During and After Hospitalization With a Mobile App-based Contingency Management Intervention: A Feasibility and Acceptability Study. J Addict Med. 2025 Nov 25:10.1097/ADM.0000000000001621. doi: 10.1097/ADM.0000000000001621. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile-app based contingency management in people with Amphetamine-Related Disorders, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention acceptability and feasibility (time frame: Week 0-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05515757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.