- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02709317
Preventing Risky Drinking in Veterans Treated With Prescription Opioids
December 9, 2021 updated by: University of Pennsylvania
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 further prevention/BI 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 (yes/no).
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Philadelphia VA Medical Center
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Pittsburgh, Pennsylvania, United States, 15261
- VA Pittsburgh Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- currently be receiving daily treatment with a prescription opioid for chronic pain;
- be 18 years or older;
- have a cell phone capable of receiving text messages;
- and be willing to be in a study where they might receive text messages.
Exclusion Criteria:
- meet DSM-V criteria for a moderate to severe alcohol or drug disorder (with the exception of nicotine abuse/dependence);
- have a current psychotic disorder severe enough to require inpatient treatment;
- are participating in substance abuse treatment at the VA or elsewhere (with exception of screening and brief intervention at the VA).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Care
In this arm, veterans receive the care that they would receive had they not enrolled in the research.
No one will receive less than standard care.
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Experimental: Prevention Intervention
An adaptive monitoring intervention, delivered through text messages and brief telephone calls, that can provide extended prevention services for veterans engaging in risky alcohol use.
After a veteran receives a BI for risky drinking, we will monitor alcohol use for 4 weeks.
Veterans who reduce alcohol use to safe levels will be placed in a monitoring track, which consists of tailored text messages and brief monthly telephone contacts.
Conversely, veterans who continue to use alcohol at hazardous levels will be placed in a track that provides tailored text messages and more frequent telephone calls.
These calls provide further prevention/intervention services to help the veteran reduce alcohol use.
These services address motivational issues and identify more effective ways to cope with stress and other factors that trigger unsafe alcohol use.
Information on the veteran's progress is used to guide the content of subsequent text messages and prevention interventions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rates of Risky Drinking, Week 13
Time Frame: weeks 1 - 13
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The primary outcome measure will be rates of the presence of any risky drinking in each week (i.e., more than 4 drinks per drinking day) as reported on the Time Line Follow Back.
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weeks 1 - 13
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Rates of Risky Drinking, Week 26
Time Frame: weeks 14 - 26
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Rates of the presence of any risky drinking in each week (14 - 26)
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weeks 14 - 26
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Rates of Risky Drinking, Week 39
Time Frame: weeks 27 - 39
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Rates of the presence of any risky drinking in each week (27 - 39)
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weeks 27 - 39
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Rates of Risky Drinking, Week 52
Time Frame: weeks 40 - 52
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Rates of the presence of any risky drinking in each week (40 - 52)
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weeks 40 - 52
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Rates of Risky Drinking, Week 78
Time Frame: weeks 53 - 78
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Rates of the presence of any risky drinking in each week (53 - 78)
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weeks 53 - 78
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: James R McKay, PhD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2014
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
September 30, 2020
Study Registration Dates
First Submitted
January 28, 2016
First Submitted That Met QC Criteria
March 10, 2016
First Posted (Estimate)
March 16, 2016
Study Record Updates
Last Update Posted (Actual)
March 2, 2022
Last Update Submitted That Met QC Criteria
December 9, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 818671
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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