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NCT05552040 · ClinicalTrials.gov registry record · NA
START NOW in the Treatment of Opioid Addicted Individuals
A NA study, sponsored by Carilion Clinic.
- Completed
- Registry status
- NA
- Development phase
- 141
- Enrollment target
NCT05552040 is a NA study that has completed, run by Carilion Clinic. The registered enrollment target is 141 participants.
The verdict
NCT05552040, a NA study, has completed, sponsored by Carilion Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 141 participants
- Enrollment target
Study Summary
This investigation involves a partially randomized clinical trial examining the effectiveness of combining buprenorphine/naloxone MAT with START NOW, a skills-based psychosocial intervention modified specifically for the ambulatory substance use disorder (SUD) patient population. START NOW is an integrated evidence-informed model based on an adapted form of dialectical behavior therapy (DBT), a type of cognitive behavior therapy (CBT) with promising indications for treating SUD as it targets impulsive and self-destructive behaviors. Furthermore, START NOW combines CBT, the most widely used evidence-based psychosocial intervention for treating mental disorders, with motivational interviewing, which in clinical trials has been shown to be an effective technique for engaging patients with SUD. In addition to tracking clinical outcomes such as abstinence rates through weekly urine drug screens, this investigation will use: clinician assessments of disease severity, researcher-evaluated tests of delayed discounting (DD) and demand tasks, and self-report surveys assessing impulsivity, aggression, interpersonal skills, and other measures to capture the patients' sense of progress in treatment in regards to their substance use, health, lifestyle, and community. By using DD and functional magnetic resonance imaging (fMRI), the identification of the neural correlates of START NOW treatment response will begin to elucidate the mechanisms of START NOW's effects and more. This investigation's outcome measures may not only compare the effectiveness between START NOW and treatment-as-usual (TAU), but also provide a more realistic, holistic view of patients and their well-being throughout the recovery process. DD will be performed by both START NOW group members and TAU group members at their group therapy meetings as per protocol. Additionally, START NOW group members randomized and consented to have an fMRI will also perform DD before the scan is initiated.
Interventions
- BEHAVIORAL START NOW Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2018-10-04 |
| Est. Completion | 2020-05-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05552040
The ClinicalTrials.gov registry entry for NCT05552040 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carilion Clinic, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which START NOW Group is the first listed.
NCT05552040 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05552040 about?
NCT05552040 is a clinical study titled "START NOW in the Treatment of Opioid Addicted Individuals". This investigation involves a partially randomized clinical trial examining the effectiveness of combining buprenorphine/naloxone MAT with START NOW, a skills-based psychosocial intervention modified specifically for the ambulatory substance use disorder (SUD) patient population. START NOW is an int...
What is the current status of trial NCT05552040?
This trial is currently completed. It is a NA study. The enrollment target is 141 participants. The study started on 2018-10-04. Estimated completion is 2020-05-01.
What interventions are being tested in trial NCT05552040?
The interventions under investigation include: START NOW Group (BEHAVIORAL).
Who is sponsoring clinical trial NCT05552040?
This trial is sponsored by Carilion Clinic, which has 45 total clinical trials registered on ClinicalTrials.gov.
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