Alcohol Drinking, Opiates, Pain
Conditions
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.
Interventions
BEHAVIORALPrevention Intervention
BEHAVIORALBrief Intervention
Sponsors
United States Department of Defense
Corporal Michael J. Crescenz VA Medical Center
Medical University of South Carolina
VA Pittsburgh Healthcare System
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Risky Drinking, Week 13 | 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 | weeks 14 - 26 | Rates of the presence of any risky drinking in each week (14 - 26) |
| Rates of Risky Drinking, Week 39 | weeks 27 - 39 | Rates of the presence of any risky drinking in each week (27 - 39) |
| Rates of Risky Drinking, Week 52 | weeks 40 - 52 | Rates of the presence of any risky drinking in each week (40 - 52) |
| Rates of Risky Drinking, Week 78 | weeks 53 - 78 | Rates of the presence of any risky drinking in each week (53 - 78) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care 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.
Brief Intervention | 50 |
| Prevention Intervention 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.
Prevention Intervention
Brief Intervention | 58 |
| Total | 108 |
Baseline characteristics
| Characteristic | Standard Care | Total | Prevention Intervention |
|---|---|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 10.3 | 59.1 years STANDARD_DEVIATION 11.03 | 58.5 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 101 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 59 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) White | 19 Participants | 41 Participants | 22 Participants |
| Region of Enrollment United States | 50 participants | 108 participants | 58 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 46 Participants | 100 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 50 | 0 / 58 |
| other Total, other adverse events | 0 / 50 | 1 / 58 |
| serious Total, serious adverse events | 4 / 50 | 8 / 58 |
Outcome results
Primary
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.
Time frame: weeks 1 - 13
Population: The analysis only includes participants for whom the data during this time period is complete. In addition, due to our finding that patients were unwilling to initially disclose alcohol use at screening, we enrolled people who were not necessarily drinking but monitored them. Once they began drinking they were received the intervention (or standard care) and were included in the analyses. However, many enrolled participants were not active drinkers and were not included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Rates of Risky Drinking, Week 13 | 3.03 risky drinking weeks | Standard Deviation 0.83 |
| Prevention Intervention | Rates of Risky Drinking, Week 13 | 2.46 risky drinking weeks | Standard Deviation 0.65 |
Primary
Rates of Risky Drinking, Week 26
Rates of the presence of any risky drinking in each week (14 - 26)
Time frame: weeks 14 - 26
Population: The analysis only includes participants for whom the data during this time period is complete. In addition, due to our finding that patients were unwilling to initially disclose alcohol use at screening, we enrolled people who were not necessarily drinking but monitored them. Once they began drinking they were received the intervention (or standard care) and were included in the analyses. However, many enrolled participants were not active drinkers and were not included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Rates of Risky Drinking, Week 26 | 2.97 risky drinking weeks | Standard Deviation 0.76 |
| Prevention Intervention | Rates of Risky Drinking, Week 26 | 2.15 risky drinking weeks | Standard Deviation 0.55 |
Primary
Rates of Risky Drinking, Week 39
Rates of the presence of any risky drinking in each week (27 - 39)
Time frame: weeks 27 - 39
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Rates of Risky Drinking, Week 39 | 2.96 risky drinking weeks | Standard Deviation 0.79 |
| Prevention Intervention | Rates of Risky Drinking, Week 39 | 2.44 risky drinking weeks | Standard Deviation 0.65 |
Primary
Rates of Risky Drinking, Week 52
Rates of the presence of any risky drinking in each week (40 - 52)
Time frame: weeks 40 - 52
Population: The analysis only includes participants for whom the data during this time period is complete. In addition, due to our finding that patients were unwilling to initially disclose alcohol use at screening, we enrolled people who were not necessarily drinking but monitored them. Once they began drinking they were received the intervention (or standard care) and were included in the analyses. However, many enrolled participants were not active drinkers and were not included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Rates of Risky Drinking, Week 52 | 3.85 risky drinking weeks | Standard Deviation 1.03 |
| Prevention Intervention | Rates of Risky Drinking, Week 52 | 2.50 risky drinking weeks | Standard Deviation 0.66 |
Primary
Rates of Risky Drinking, Week 78
Rates of the presence of any risky drinking in each week (53 - 78)
Time frame: weeks 53 - 78
Population: The analysis only includes participants for whom the data during this time period is complete. In addition, due to our finding that patients were unwilling to initially disclose alcohol use at screening, we enrolled people who were not necessarily drinking but monitored them. Once they began drinking they were received the intervention (or standard care) and were included in the analyses. However, many enrolled participants were not active drinkers and were not included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Rates of Risky Drinking, Week 78 | 4.60 risky drinking weeks | Standard Deviation 1.31 |
| Prevention Intervention | Rates of Risky Drinking, Week 78 | 2.70 risky drinking weeks | Standard Deviation 0.91 |