NCT03999450

Preventing Premature Death in Patients With Serious Opioid-related Infection

Preventing Premature Death Among Hospital Patients With Serious Opioid-Related Infection (SORI): A Phase 1 Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the efficacy of a combination of motivational interventions and a brief therapy session to increase the adherence to medication-assisted treatment (MAT) for opioids.

Detailed description

We will recruit 30 SORI inpatients ages 18-plus admitted to the University of Rochester Medical Center (URMC). We will administer a battery of validated assessments of substance use, overdose history and risk, opioid-related infection, and suicidal behavior at baseline and approximately 2- and 4-week follow-ups. We will assess both forms of overdose (unintentional, intentional - i.e., suicidal behavior) because each is common in intravenous drug users and they require systematic assessment to disentangle. All recruited individuals will receive one-to-three MI sessions as they begin the MAT that is part of standard hospital care. Patients will be offered computer-based CBT, which they will complete on the unit at their convenience. The CBT program records duration of use of the treatment modules, enabling us to track patients' level of CBT treatment participation. Patient-completed intervention feedback forms and treatment completion will be examined after 15 subjects have participated. Based on this feedback, we will pilot an adapted (MI plus CBT) treatment manual, obtaining additional feedback on acceptability. We will assess psychopathy, a constellation of stable traits and potentially important moderator of treatment effects, at baseline. We will assess potential mediators (i.e., motivation to change, self-regulation) using validated measures at baseline and at approximately 2- and 4-weeks post-discharge.

Conditions

• Opioid Use

Interventions

Type	Name	Description
BEHAVIORAL	brief motivational intervention (BMI)	The intervention typically takes 45 minutes to administer and is designed to enhance motivation to change and includes the following components: establishing rapport, asking permission to discuss substance use and providing feedback regarding the substance use assessment, exploring personal consequences of drug use, eliciting the gap between real and desired quality of life, and discussing readiness to change. The therapist then negotiates a written action plan, during which the subject is supported with empathy and verbal reinforcement.
BEHAVIORAL	cognitive behavioral therapy	This evidence-based, online, Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) program covers six lessons: 1) changing patterns of use, 2) coping with craving, 3) refusing drugs, 4) problem-solving skills, 5) changing drug-related thoughts, and 6) improving decision-making. The program is designed to be user-friendly and includes videotaped instructions and examples, interactive assessments, and practice exercises.

Timeline

• Start date: 2019-10-08
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2019-06-26
• Last updated: 2020-07-28

Locations

1 site across 1 country: United States