Preventing Risky Drinking in Veterans Treated With Prescription Opioids
Condition: Pain; Opiates; Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional

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.
    


Intervention name(s): Prevention Intervention; Brief Intervention
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention