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Preventing Risky Drinking in Veterans Treated With Prescription Opioids

Primary Purpose

Pain, Opiates, Alcohol Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevention Intervention
Brief Intervention
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Philadelphia VA Medical Center
  • University of Pennsylvania
  • VA Pittsburgh Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care

Prevention Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rates of Risky Drinking, Week 13
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.
Rates of Risky Drinking, Week 26
Rates of the presence of any risky drinking in each week (14 - 26)
Rates of Risky Drinking, Week 39
Rates of the presence of any risky drinking in each week (27 - 39)
Rates of Risky Drinking, Week 52
Rates of the presence of any risky drinking in each week (40 - 52)
Rates of Risky Drinking, Week 78
Rates of the presence of any risky drinking in each week (53 - 78)

Secondary Outcome Measures

Full Information

First Posted
January 28, 2016
Last Updated
December 9, 2021
Sponsor
University of Pennsylvania
Collaborators
United States Department of Defense, Corporal Michael J. Crescenz VA Medical Center, Medical University of South Carolina, VA Pittsburgh Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT02709317
Brief Title
Preventing Risky Drinking in Veterans Treated With Prescription Opioids
Official Title
Preventing Risky Drinking in Veterans Treated With Prescription Opioids
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
United States Department of Defense, Corporal Michael J. Crescenz VA Medical Center, Medical University of South Carolina, VA Pittsburgh Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Opiates, Alcohol Drinking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Prevention Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prevention Intervention
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention
Primary Outcome Measure Information:
Title
Rates of Risky Drinking, Week 13
Description
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.
Time Frame
weeks 1 - 13
Title
Rates of Risky Drinking, Week 26
Description
Rates of the presence of any risky drinking in each week (14 - 26)
Time Frame
weeks 14 - 26
Title
Rates of Risky Drinking, Week 39
Description
Rates of the presence of any risky drinking in each week (27 - 39)
Time Frame
weeks 27 - 39
Title
Rates of Risky Drinking, Week 52
Description
Rates of the presence of any risky drinking in each week (40 - 52)
Time Frame
weeks 40 - 52
Title
Rates of Risky Drinking, Week 78
Description
Rates of the presence of any risky drinking in each week (53 - 78)
Time Frame
weeks 53 - 78

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R McKay, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia VA Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
VA Pittsburgh Health System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

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Preventing Risky Drinking in Veterans Treated With Prescription Opioids

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