Preventing Risky Drinking in Veterans Treated With Prescription Opioids

NCT02709317 | Completed Results

• 1 other identifier: 818671
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 3

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.

Conditions

Pain; Opiates; Alcohol Drinking

Outcome Measures

Primary Outcomes (5)

• Rates of Risky Drinking, Week 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.

  weeks 1 - 13

• Rates of Risky Drinking, Week 26

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

  weeks 14 - 26

• Rates of Risky Drinking, Week 39

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

  weeks 27 - 39

• Rates of Risky Drinking, Week 52

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

  weeks 40 - 52

• Rates of Risky Drinking, Week 78

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

  weeks 53 - 78

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

In this arm, veterans receive the care that they would receive had they not enrolled in the research. No one will receive less than standard care.

Behavioral: Brief Intervention

Prevention Intervention

EXPERIMENTAL

An adaptive monitoring intervention, delivered through text messages and brief telephone calls, that can provide extended prevention services for veterans engaging in risky alcohol use. After a veteran receives a BI for risky drinking, we will monitor alcohol use for 4 weeks. Veterans who reduce alcohol use to safe levels will be placed in a monitoring track, which consists of tailored text messages and brief monthly telephone contacts. Conversely, veterans who continue to use alcohol at hazardous levels will be placed in a track that provides tailored text messages and more frequent telephone calls. These calls provide further prevention/intervention services to help the veteran reduce alcohol use. These services address motivational issues and identify more effective ways to cope with stress and other factors that trigger unsafe alcohol use. Information on the veteran's progress is used to guide the content of subsequent text messages and prevention interventions.

Behavioral: Prevention Intervention; Behavioral: Brief Intervention

Interventions

Prevention Intervention BEHAVIORAL

Prevention Intervention

Brief Intervention BEHAVIORAL

Prevention Intervention; Standard Care

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (3)

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

VA Pittsburgh Health System

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Pain; Alcohol Drinking

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: James McKay
• Organization: University of Pennsylvania

jimrache@upenn.edu

215-746-7704

Study Officials

• James R McKay, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: March 16, 2016
• Study Start: April 1, 2014
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2021-12

Locations

US (3)