Clinical trial NCT02709317: Preventing Risky Drinking in Veterans Treated With Prescription Opioids
Official title: Preventing Risky Drinking in Veterans Treated With Prescription Opioids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Opiates
Alcohol Drinking
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Corporal Michael J. Crescenz VA Medical Center
name: Medical University of South Carolina
name: VA Pittsburgh Healthcare System
First posted: 2016-03-16
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: Rates of Risky Drinking, Week 13
timeFrame: weeks 1 - 13
measure: Rates of Risky Drinking, Week 26
timeFrame: weeks 14 - 26
measure: Rates of Risky Drinking, Week 39
timeFrame: weeks 27 - 39
measure: Rates of Risky Drinking, Week 52
timeFrame: weeks 40 - 52
measure: Rates of Risky Drinking, Week 78
timeFrame: weeks 53 - 78
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James R McKay, PhD
role: PRINCIPAL_INVESTIGATOR
References: