Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02709317
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2016-01-28
Brief Title:
Preventing Risky Drinking in Veterans Treated With Prescription Opioids
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Preventing Risky Drinking in Veterans Treated With Prescription Opioids
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 N300 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 eg 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 further preventionBI services to help the veteran reduce alcohol use to non-hazardous levels Key components of these services are motivational enhancement and development of more effective ways to cope with stress and other triggers for risky alcohol use All participants will be followed up at 3 6 9 12 and 18 months after baseline The primary outcome at each follow-up point will be a dichotomous measure of any risky drinking since the prior follow-up yesno Secondary outcomes will include self-reported frequency of heavy drinking biological measures of alcohol use other drug use as determined by urine toxicology tests opioid overdoses and ratings of depression and pain Repeated measures analyses will compare the PI and SC conditions on primary and secondary outcomes assessed across an 18-month follow-up Analyses will also test hypothesized moderation and mediation effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None