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NCT02709317 · ClinicalTrials.gov registry record · NA

Preventing Risky Drinking in Veterans Treated With Prescription Opioids

A NA study, sponsored by University of Pennsylvania.

Completed
Registry status
NA
Development phase
108
Enrollment target

NCT02709317: Completed NA study, sponsored by University of Pennsylvania.

NCT02709317 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 108 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02709317, a NA study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
NA
Development phase
108 participants
Enrollment target

Study Summary

Veterans who are taking prescription opioids for chronic pain and are engaging in risky drinking are at heightened risk for drug interactions, including overdose and other negative effects, particularly if they are also using benzodiazepines. The investigators propose to test a prevention intervention, designed to reduce rates of risky drinking in veterans receiving prescription opioids to treat their chronic pain. This adaptive, patient-centered intervention provides clinical assessment, brief intervention, monitoring, and extended prevention services delivered through a combination of clinical visits, telephone calls, and text messages. The investigators propose to conduct a study in which veterans (N=300) who are on daily doses of prescription opioids will be randomized to receive 12 months of an adaptive prevention intervention (PI) or to standard care (SC), which consists of a Brief Intervention (BI) with 2 follow-up contacts. Potential participants will be veterans at the Philadelphia VA, and surrounding areas, or the Pittsburgh VA who, based on pharmacy records, are using opioids daily to treat chronic pain. An initial evaluation will identify individuals who also engage in risky alcohol use based on NIAAA-recommended guidelines and meet other inclusion criteria to be enrolled in the study. The evaluation will also identify the use of other medications (e.g., benzodiazepines) that could interact negatively with opioid use. For veterans randomized to the PI condition, a BI is first provided to reduce alcohol to non-hazardous levels and the effects are monitored for one month. Veterans who reduce alcohol use to non-hazardous levels during this one-month period continue in a monitoring track, consisting of tailored text messages and brief monthly telephone contacts. Veterans who continue to drink at risky levels are instead placed in a track that provides tailored text messages and more frequent telephone calls. In addition to monitoring, these calls provide fur

Interventions

  • BEHAVIORAL Brief Intervention
  • BEHAVIORAL Prevention Intervention

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2014-04
Est. Completion 2020-09-30
Phase NA

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT02709317

The ClinicalTrials.gov registry entry for NCT02709317 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Brief Intervention is the first listed.

NCT02709317 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02709317 about?

NCT02709317 is a clinical study titled "Preventing Risky Drinking in Veterans Treated With Prescription Opioids". Veterans who are taking prescription opioids for chronic pain and are engaging in risky drinking are at heightened risk for drug interactions, including overdose and other negative effects, particularly if they are also using benzodiazepines. The investigators propose to test a prevention interventi...

What is the current status of trial NCT02709317?

This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2014-04. Estimated completion is 2020-09-30.

What interventions are being tested in trial NCT02709317?

The interventions under investigation include: Brief Intervention (BEHAVIORAL), Prevention Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT02709317?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.