Trial Outcomes & Findings for Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT) (NCT NCT04180020)
NCT ID: NCT04180020
Last Updated: 2025-04-03
Results Overview
Enrollment in effective medication treatment for OUD (either buprenorphine maintenance, methadone maintenance, or extended-release naltrexone) will be ascertained through interview of the participant at each assessment point, using a modified, brief version of the Treatment Services Review that records type and dose of medication treatment, contact information on the treatment program, and psychosocial treatment modalities accessed since the previous visit (e.g. professional counseling, 12-step group participation). The primary outcome will be a binary indicator of whether or not the patient is enrolled on buprenorphine maintenance treatment or other effective medication (methadone maintenance or extended-release naltrexone) at 12 weeks after randomization, verified by either report from the treatment program, or if the treatment program does not respond, prescription drug monitoring report or EMR.
COMPLETED
NA
171 participants
12 weeks
2025-04-03
Participant Flow
Participant milestones
| Measure |
Treatment as Usual (TAU).
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
86
|
|
Overall Study
Missed 12 Week Visit
|
18
|
16
|
|
Overall Study
COMPLETED
|
63
|
59
|
|
Overall Study
NOT COMPLETED
|
22
|
27
|
Reasons for withdrawal
| Measure |
Treatment as Usual (TAU).
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Overall Study
missed visit
|
18
|
16
|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
incarcerated
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT)
Baseline characteristics by cohort
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
n=5 Participants
|
38 years
n=7 Participants
|
39 years
n=5 Participants
|
|
Sex/Gender, Customized
Men
|
42 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Women
|
43 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender women
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=5 Participants
|
86 participants
n=7 Participants
|
171 participants
n=5 Participants
|
|
Housing Status
Unhoused
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Housing Status
Unstable Housing
|
37 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Housing Status
Stable Housing
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Housing Status
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
High School or above
|
68 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Education
Less than high school
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Education
Did not respond
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Marital Status
Living with partner
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Marital Status
Married
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Marital Status
Never married
|
40 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Marital Status
Separated
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Marital Status
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Income group
Less than $5,000
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Income group
$5,000-9,999
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Income group
$10.000-24,999
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Income group
$25,000-49,999
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Income group
$50,000 or more
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Income group
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Type of insurance
Medicaid
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Type of insurance
Medicare
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Type of insurance
Private insurance
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Type of insurance
Other insurance
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Type of insurance
None
|
39 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Type of insurance
Did not respond
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Engaged in condomless sex
Yes
|
48 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Engaged in condomless sex
No
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Engaged in condomless sex
Did not respond
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Median number of condomless sex partners
|
1 partners
n=5 Participants
|
1 partners
n=7 Participants
|
1 partners
n=5 Participants
|
|
WHO Quality of Life-BREF (WHOQOL-BREF)
Physical Health
|
42.9 score on a scale
n=5 Participants
|
39.3 score on a scale
n=7 Participants
|
39.3 score on a scale
n=5 Participants
|
|
WHO Quality of Life-BREF (WHOQOL-BREF)
Psychological
|
45.8 score on a scale
n=5 Participants
|
45.8 score on a scale
n=7 Participants
|
45.8 score on a scale
n=5 Participants
|
|
WHO Quality of Life-BREF (WHOQOL-BREF)
Social Relationships
|
45.8 score on a scale
n=5 Participants
|
54.2 score on a scale
n=7 Participants
|
50.0 score on a scale
n=5 Participants
|
|
WHO Quality of Life-BREF (WHOQOL-BREF)
Environmental
|
53.1 score on a scale
n=5 Participants
|
56.7 score on a scale
n=7 Participants
|
56.3 score on a scale
n=5 Participants
|
|
Provisional Post-traumatic stress disorder (PTSD) Diagnosis
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Depression Severity
None or mild
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Depression Severity
Moderate or above
|
57 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Depression Severity
Did not answer
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Provisional Attention-deficit/hyperactivity disorder (ADHD)
|
50 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Pain Scale score via Pain, Enjoyment of Life and General Activity (PEG) Scale
|
6.0 score on a scale
n=5 Participants
|
6.0 score on a scale
n=7 Participants
|
6.0 score on a scale
n=5 Participants
|
|
Opioid Craving Scale
|
1.00 score on a scale
n=5 Participants
|
1.00 score on a scale
n=7 Participants
|
1.00 score on a scale
n=5 Participants
|
|
Opioid withdrawal (mild or greater)
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Hazardous/Harmful Drinking
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Co-occurring stimulant use disorder
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Prescribed MOUD in past 30 days
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Opiates · Negative
|
71 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Opiates · Positive
|
11 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Opiates · Missing
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Oxycodone · Negative
|
62 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Oxycodone · Positive
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Oxycodone · Missing
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Fentanyl · Negative
|
42 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Fentanyl · Positive
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Fentanyl · Missing
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Methadone · Negative
|
67 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Methadone · Positive
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Methadone · Missing
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Buprenorphine · Negative
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Buprenorphine · Positive
|
51 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Buprenorphine · Missing
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Cocaine · Negative
|
77 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Cocaine · Positive
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Cocaine · Missing
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Methamphetamine · Negative
|
70 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Methamphetamine · Positive
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Methamphetamine · Missing
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Benzodiazepine · Negative
|
62 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Benzodiazepine · Positive
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Positive urine toxicology screen at time of enrollment
Benzodiazepine · Missing
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Heroin · No
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Heroin · Yes
|
57 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Heroin · Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Prescription opioids · No
|
68 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Prescription opioids · Yes
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Prescription opioids · Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Fentanyl · No
|
45 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Fentanyl · Yes
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Fentanyl · Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Other opioids · No
|
78 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Other opioids · Yes
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Other opioids · Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Cocaine · No
|
56 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Cocaine · Yes
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Cocaine · Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Methamphetamine · No
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Methamphetamine · Yes
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Self-reported substances used 30 days prior to hospitalization
Methamphetamine · Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Visited health care provider in last 12 months, excluding urgent care
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Covered by health insurance 30 days before interview
|
46 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Engaged in injection drug use
No
|
31 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Engaged in injection drug use
Yes
|
53 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Engaged in injection drug use
Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Shared injection drug equipment
No
|
35 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Shared injection drug equipment
Yes
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Shared injection drug equipment
Missing
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Shared injection drug equipment
Does not apply
|
31 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Index Infection
HIV diagnosis
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Index Infection
HIV viral load ≥ 200
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Index Infection
Hepatitis C, Ab positive
|
53 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Index Infection
Hepatitis C, with detectable viral load
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Index Infection
Hepatitis B
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Index Infection
Bloodstream infection
|
36 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Index Infection
Endocarditis
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Index Infection
Septic arthritis
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Index Infection
Osteomyelitis
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Index Infection
Pneumonia/respiratory infection (non-COVID-19)
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Index Infection
Septic thrombophlebitis
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Index Infection
Skin/skin structure infection
|
11 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Index Infection
Abscess including skin/soft tissue, intra-abdominal, epidural, and other
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Index Infection
COVID-19 Infection
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Index Infection
Sexually transmitted infection
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Index Infection
Other
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksEnrollment in effective medication treatment for OUD (either buprenorphine maintenance, methadone maintenance, or extended-release naltrexone) will be ascertained through interview of the participant at each assessment point, using a modified, brief version of the Treatment Services Review that records type and dose of medication treatment, contact information on the treatment program, and psychosocial treatment modalities accessed since the previous visit (e.g. professional counseling, 12-step group participation). The primary outcome will be a binary indicator of whether or not the patient is enrolled on buprenorphine maintenance treatment or other effective medication (methadone maintenance or extended-release naltrexone) at 12 weeks after randomization, verified by either report from the treatment program, or if the treatment program does not respond, prescription drug monitoring report or EMR.
Outcome measures
| Measure |
Treatment as Usual (TAU).
n=85 Participants
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 Participants
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Number of Participants With Retention in Medication Treatment for OUD
|
46 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: 4 weeksThis outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug, for the 30 days before baseline, and for each day over the follow up period, using calendars and memory aids to enhance recall.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksThis outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug, for the 30 days before baseline, and for each day over the follow up period, using calendars and memory aids to enhance recall.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksThis outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug, for the 30 days before baseline, and for each day over the follow up period, using calendars and memory aids to enhance recall.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksThis outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug, for the 30 days before baseline, and for each day over the follow up period, using calendars and memory aids to enhance recall.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksThis outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksThis outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksThis outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksThis outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksThis outcome is assessed by the Medical/Infectious Disease/TAU questionnaire. This form documents the completion of antimicrobial therapy and re-hospitalization for infection. The initial evaluation documents the relevant infection and medical details such as infection site, organism, and stage. It also extracts the type of ant-infective, route of administration, dose, and planned duration. Information on follow-up is collected alteration of treatment plan, infection related adverse events (e.g. PICC complications, drug reaction/toxicity to anti-infective agent prescribed by non-study clinicians, etc), and intervening hospitalizations. Completion success is defined as appropriate completion of antimicrobial therapy, as documented in the initial assessment, without interruption or unexpected prolongation of therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksThis outcome is assessed by the Medical/Infectious Disease/TAU questionnaire. This form documents the completion of antimicrobial therapy and re-hospitalization for infection. The initial evaluation documents the relevant infection and medical details such as infection site, organism, and stage. It also extracts the type of ant-infective, route of administration, dose, and planned duration. Information on follow-up is collected alteration of treatment plan, infection related adverse events (e.g. PICC complications, drug reaction/toxicity to anti-infective agent prescribed by non-study clinicians, etc), and intervening hospitalizations. Completion success is defined as appropriate completion of antimicrobial therapy, as documented in the initial assessment, without interruption or unexpected prolongation of therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksThis outcome is assessed by the Medical/Infectious Disease/TAU questionnaire. This form documents the completion of antimicrobial therapy and re-hospitalization for infection. The initial evaluation documents the relevant infection and medical details such as infection site, organism, and stage. It also extracts the type of ant-infective, route of administration, dose, and planned duration. Information on follow-up is collected alteration of treatment plan, infection related adverse events (e.g. PICC complications, drug reaction/toxicity to anti-infective agent prescribed by non-study clinicians, etc), and intervening hospitalizations. Completion success is defined as appropriate completion of antimicrobial therapy, as documented in the initial assessment, without interruption or unexpected prolongation of therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksThis outcome is assessed by the Medical/Infectious Disease/TAU questionnaire. This form documents the completion of antimicrobial therapy and re-hospitalization for infection. The initial evaluation documents the relevant infection and medical details such as infection site, organism, and stage. It also extracts the type of ant-infective, route of administration, dose, and planned duration. Information on follow-up is collected alteration of treatment plan, infection related adverse events (e.g. PICC complications, drug reaction/toxicity to anti-infective agent prescribed by non-study clinicians, etc), and intervening hospitalizations. Completion success is defined as appropriate completion of antimicrobial therapy, as documented in the initial assessment, without interruption or unexpected prolongation of therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksRe-hospitalizations and emergency room presentations related to either their infectious disease or OUD will be totaled over the intervention duration and 12-week follow-up period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksRe-hospitalizations and emergency room presentations related to either their infectious disease or OUD will be totaled over the intervention duration and 12-week follow-up period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksQuality of life is measured using the WHOQOL-Bref, which is a is a well validated and widely used scale for persons with substance use disorders that measures the quality of social and occupational functioning as well as other domains. Scores are scaled in a positive direction (higher scores indicate a higher quality of life). A total of 500 is the highest score attainable and indicates highest quality of life in respondents.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksQuality of life is measured using the WHOQOL-Bref, which is a is a well validated and widely used scale for persons with substance use disorders that measures the quality of social and occupational functioning as well as other domains. Scores are scaled in a positive direction (higher scores indicate a higher quality of life). A total of 500 is the highest score attainable and indicates highest quality of life in respondents.
Outcome measures
Outcome data not reported
Adverse Events
Treatment as Usual (TAU).
ID/LAB
Serious adverse events
| Measure |
Treatment as Usual (TAU).
n=85 participants at risk
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 participants at risk
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Nervous system disorders
Opioid Withdrawal
|
1.2%
1/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin/soft tissue infection
|
16.5%
14/85 • 24 weeks
|
18.6%
16/86 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Nervous system disorders
Non-fatal opioid overdose
|
2.4%
2/85 • 24 weeks
|
2.3%
2/86 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/85 • 24 weeks
|
3.5%
3/86 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
|
Infections and infestations
Respiratory infection (not including COVID-19)
|
1.2%
1/85 • 24 weeks
|
3.5%
3/86 • 24 weeks
|
Other adverse events
| Measure |
Treatment as Usual (TAU).
n=85 participants at risk
Treatment as Usual (TAU).
TAU: TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
|
ID/LAB
n=86 participants at risk
Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
|
|---|---|---|
|
Nervous system disorders
Opioid Withdrawal
|
10.6%
9/85 • 24 weeks
|
16.3%
14/86 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin/soft tissue infection
|
10.6%
9/85 • 24 weeks
|
8.1%
7/86 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
6/85 • 24 weeks
|
9.3%
8/86 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.9%
5/85 • 24 weeks
|
11.6%
10/86 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.2%
7/85 • 24 weeks
|
8.1%
7/86 • 24 weeks
|
|
Nervous system disorders
Headache
|
4.7%
4/85 • 24 weeks
|
10.5%
9/86 • 24 weeks
|
|
Vascular disorders
Edema
|
7.1%
6/85 • 24 weeks
|
5.8%
5/86 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
6/85 • 24 weeks
|
5.8%
5/86 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.7%
4/85 • 24 weeks
|
7.0%
6/86 • 24 weeks
|
|
General disorders
Injection site reaction
|
0.00%
0/85 • 24 weeks
|
10.5%
9/86 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
4/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.7%
4/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/85 • 24 weeks
|
8.1%
7/86 • 24 weeks
|
|
General disorders
Diaphoresis
|
3.5%
3/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
|
General disorders
Fatigue
|
5.9%
5/85 • 24 weeks
|
2.3%
2/86 • 24 weeks
|
|
Immune system disorders
Fever
|
3.5%
3/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
|
Nervous system disorders
Non-fatal opioid overdose
|
7.1%
6/85 • 24 weeks
|
1.2%
1/86 • 24 weeks
|
|
Nervous system disorders
Insomnia
|
2.4%
2/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/85 • 24 weeks
|
5.8%
5/86 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.7%
4/85 • 24 weeks
|
0.00%
0/86 • 24 weeks
|
|
Infections and infestations
Respiratory infection (not including COVID-19)
|
0.00%
0/85 • 24 weeks
|
4.7%
4/86 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place