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.
Looking for future studies?
Notify MeKey information
Conditions
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
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
Brief intervention
BehavioralPrimary outcomes
-
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.
-
Rates of Risky Drinking, Week 26
Time frame: weeks 14 - 26
Rates of the presence of any risky drinking in each week (14 - 26)
-
Rates of Risky Drinking, Week 39
Time frame: weeks 27 - 39
Rates of the presence of any risky drinking in each week (27 - 39)
-
Rates of Risky Drinking, Week 52
Time frame: weeks 40 - 52
Rates of the presence of any risky drinking in each week (40 - 52)
-
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Personalized Feedback Intervention for Alcohol and Opioid Use Among Adults With Chronic Pain
NCT04592978
Alcohol Drinking, Behavior
Syracuse, New York, United States
View Trial DetailsThe Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates
NCT03311594
Acute Pain, Alcohol Drinking
Syracuse, New York, United States
View Trial DetailsSt. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene
NCT03278886
Alcohol Drinking, Alcohol Use
Saint Petersburg, Russia
View Trial DetailsBrief Mindfulness Intervention for Patients at a Free Acute Care Clinic
NCT07025161
Neurologic Manifestations, Pain
Orlando, Florida, United States
View Trial Details