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OpenTrials
Completed

NCT Number: NCT02709317

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 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.

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Key information

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philadelphia VA Medical Center, Philadelphia, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Prevention Intervention

Behavioral

Brief intervention

Behavioral

Primary outcomes

  1. Rates of Risky Drinking, Week 13

    Time frame: weeks 1 - 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.

  2. Rates of Risky Drinking, Week 26

    Time frame: weeks 14 - 26

    Rates of the presence of any risky drinking in each week (14 - 26)

  3. Rates of Risky Drinking, Week 39

    Time frame: weeks 27 - 39

    Rates of the presence of any risky drinking in each week (27 - 39)

  4. Rates of Risky Drinking, Week 52

    Time frame: weeks 40 - 52

    Rates of the presence of any risky drinking in each week (40 - 52)

  5. Rates of Risky Drinking, Week 78

    Time frame: weeks 53 - 78

    Rates of the presence of any risky drinking in each week (53 - 78)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Corporal Michael J. Crescenz VA Medical Center
  • Medical University of South Carolina
  • United States Department of Defense
  • VA Pittsburgh Healthcare System

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Mar 16, 2016
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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