Preventing Risky Drinking in Veterans Treated With Prescription Opioids
Status: | Recruiting |
---|---|
Conditions: | Chronic Pain, Psychiatric |
Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 88 |
Updated: | 11/18/2018 |
Start Date: | April 2014 |
End Date: | October 2019 |
Contact: | James R McKay, PhD |
Email: | jimrache@pennmedicine.upenn.edu |
Phone: | 215-746-7704 |
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.
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.
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).
We found this trial at
3
sites
4100 Allequippa Street
Pittsburgh, Pennsylvania 15240
Pittsburgh, Pennsylvania 15240
Phone: 412-360-6344
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Philadelphia, Pennsylvania 19104
Principal Investigator: James R McKay, PhD
Phone: 215-746-7712
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3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: James R McKay, PhD
Phone: 215-746-7712
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