Trial Outcomes & Findings for Preventing Risky Drinking in Veterans Treated With Prescription Opioids (NCT NCT02709317)

Last Updated: 2022-03-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

108 participants

Primary outcome timeframe

weeks 1 - 13

Results posted on

2022-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	50	58
Overall Study COMPLETED	18	31
Overall Study NOT COMPLETED	32	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preventing Risky Drinking in Veterans Treated With Prescription Opioids

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care n=50 Participants 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	Prevention Intervention n=58 Participants 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	Total n=108 Participants Total of all reporting groups
Age, Continuous	59.8 years STANDARD_DEVIATION 10.3 • n=5 Participants	58.5 years STANDARD_DEVIATION 11.6 • n=7 Participants	59.1 years STANDARD_DEVIATION 11.03 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	54 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	55 Participants n=7 Participants	101 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	58 participants n=7 Participants	108 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants 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	Prevention Intervention n=44 Participants 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
Rates of Risky Drinking, Week 13	3.03 risky drinking weeks Standard Deviation 0.83	2.46 risky drinking weeks Standard Deviation 0.65

PRIMARY outcome

Timeframe: weeks 14 - 26

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

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants 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	Prevention Intervention n=38 Participants 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
Rates of Risky Drinking, Week 26	2.97 risky drinking weeks Standard Deviation 0.76	2.15 risky drinking weeks Standard Deviation 0.55

PRIMARY outcome

Timeframe: weeks 27 - 39

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

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants 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	Prevention Intervention n=23 Participants 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
Rates of Risky Drinking, Week 39	2.96 risky drinking weeks Standard Deviation 0.79	2.44 risky drinking weeks Standard Deviation 0.65

PRIMARY outcome

Timeframe: weeks 40 - 52

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

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants 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	Prevention Intervention n=23 Participants 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
Rates of Risky Drinking, Week 52	3.85 risky drinking weeks Standard Deviation 1.03	2.50 risky drinking weeks Standard Deviation 0.66

PRIMARY outcome

Timeframe: weeks 53 - 78

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

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants 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	Prevention Intervention n=23 Participants 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
Rates of Risky Drinking, Week 78	4.60 risky drinking weeks Standard Deviation 1.31	2.70 risky drinking weeks Standard Deviation 0.91

Adverse Events

Standard Care

Serious events: 4 serious events

Other events: 0 other events

Deaths: 3 deaths

Prevention Intervention

Serious events: 8 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Care n=50 participants at risk 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	Prevention Intervention n=58 participants at risk 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
Surgical and medical procedures Hospitalized	2.0% 1/50 • Number of events 2 • Adverse event data was collected for 18 months.	6.9% 4/58 • Number of events 6 • Adverse event data was collected for 18 months.
Gastrointestinal disorders hospitalized	2.0% 1/50 • Number of events 1 • Adverse event data was collected for 18 months.	0.00% 0/58 • Adverse event data was collected for 18 months.
Respiratory, thoracic and mediastinal disorders Hospitalized	0.00% 0/50 • Adverse event data was collected for 18 months.	1.7% 1/58 • Number of events 1 • Adverse event data was collected for 18 months.
General disorders hospitalized	2.0% 1/50 • Number of events 1 • Adverse event data was collected for 18 months.	0.00% 0/58 • Adverse event data was collected for 18 months.
General disorders ED visit	2.0% 1/50 • Number of events 1 • Adverse event data was collected for 18 months.	0.00% 0/58 • Adverse event data was collected for 18 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) hospitalized	0.00% 0/50 • Adverse event data was collected for 18 months.	1.7% 1/58 • Number of events 1 • Adverse event data was collected for 18 months.
Injury, poisoning and procedural complications hospitalized	0.00% 0/50 • Adverse event data was collected for 18 months.	1.7% 1/58 • Number of events 1 • Adverse event data was collected for 18 months.
Cardiac disorders Hospitalized	0.00% 0/50 • Adverse event data was collected for 18 months.	1.7% 1/58 • Number of events 2 • Adverse event data was collected for 18 months.

Other adverse events

Other adverse events
Measure	Standard Care n=50 participants at risk 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	Prevention Intervention n=58 participants at risk 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
Social circumstances emotional distress	0.00% 0/50 • Adverse event data was collected for 18 months.	1.7% 1/58 • Number of events 1 • Adverse event data was collected for 18 months.

Additional Information

James McKay

University of Pennsylvania

Phone: 215-746-7704

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place