University of Rochester Medical Center
Rochester, New York, 14642, United States
NCT Number: NCT03999450
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rochester, New York, 14642, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: week 4
The percentage of participants who completed the week 4 follow up assessments.
Time frame: week 4
Written and verbal feedback will be collected from participants.
Time frame: baseline to 2 weeks
A readiness ruler with a scale of 1- 10 where higher numbers indicate better health outcomes will be used to to assess motivation to change illicit substance use.
Time frame: baseline to 2 weeks
The Self-Regulation Questionnaire is a 63 item questionnaire with each question rated at a 5-point likert scale.
> 239 High (intact) self-regulation capacity (top quartile) 214-238 Intermediate (moderate) self-regulation capacity (middle quartiles) < 213 Low (impaired) self-regulation capacity (bottom quartile)
University of Rochester
Other
Preventing Premature Death Among Hospital Patients With Serious Opioid-Related Infection (SORI): A Phase 1 Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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