Trial Outcomes & Findings for Injectable Pharmacotherapy for Opioid Use Disorders (IPOD) (NCT NCT02110264)
NCT ID: NCT02110264
Last Updated: 2020-01-22
Results Overview
The primary objective is to compare outcomes of the three intervention groups, based on self-reports at 6-months post-intervention.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
151 participants
Primary outcome timeframe
6 months
Results posted on
2020-01-22
Participant Flow
Participant milestones
| Measure |
Vivitrol (XR-NTX)
Long-acting naltrexone condition (XR-NTX) which will included monthly injections of study drug.
|
XR-NTX+PN
Long-acting naltrexone (XR-NTX) and assignment of a patient navigator (PN).
|
ETAU
Treatment as usual, along with will receive drug education.
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
50
|
48
|
|
Overall Study
COMPLETED
|
35
|
38
|
39
|
|
Overall Study
NOT COMPLETED
|
18
|
12
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Injectable Pharmacotherapy for Opioid Use Disorders (IPOD)
Baseline characteristics by cohort
| Measure |
Vivitrol (XR-NTX)
n=46 Participants
Long-acting naltrexone condition (XR-NTX) which will include monthly injections of study drug.
|
XR-NTX+PN
n=45 Participants
Long-acting naltrexone (XR-NTX) and assigned to a patient navigator (PN).
|
ETAU
n=44 Participants
Drug-education/treatment-as-usual.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
34 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
33 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
33 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
45 participants
n=7 Participants
|
44 participants
n=5 Participants
|
135 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe primary objective is to compare outcomes of the three intervention groups, based on self-reports at 6-months post-intervention.
Outcome measures
| Measure |
Vivitrol (XR-NTX)
n=37 Participants
Long-acting naltrexone condition (XR-NTX) which included monthly injections of study drug.
|
XR-NTX+PN
n=42 Participants
Long-acting naltrexone (XR-NTX) and assignment of a patient navigator (PN).
|
ETAU
n=41 Participants
Treatment as usual, along with will receive drug education.
|
|---|---|---|---|
|
Opioid Use
|
6 Participants
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants meeting DSM-5 OUD (opioid use disorder) criteria via modified CIDI-2 Substance Abuse Module
Outcome measures
| Measure |
Vivitrol (XR-NTX)
n=37 Participants
Long-acting naltrexone condition (XR-NTX) which included monthly injections of study drug.
|
XR-NTX+PN
n=42 Participants
Long-acting naltrexone (XR-NTX) and assignment of a patient navigator (PN).
|
ETAU
n=41 Participants
Treatment as usual, along with will receive drug education.
|
|---|---|---|---|
|
Opioid Use Disorder
|
4 Participants
|
4 Participants
|
3 Participants
|
Adverse Events
Vivitrol (XR-NTX)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
XR-NTX+PN
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
ETAU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vivitrol (XR-NTX)
n=53 participants at risk
Long-acting naltrexone condition (XR-NTX) which included monthly injections of study drug.
|
XR-NTX+PN
n=50 participants at risk
Long-acting naltrexone (XR-NTX) and assignment of a patient navigator (PN).
|
ETAU
n=48 participants at risk
Treatment as usual, along with will receive drug education.
|
|---|---|---|---|
|
Hepatobiliary disorders
Helpatobiliary disorder
|
0.00%
0/53 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
2.0%
1/50 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
0.00%
0/48 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
Other adverse events
| Measure |
Vivitrol (XR-NTX)
n=53 participants at risk
Long-acting naltrexone condition (XR-NTX) which included monthly injections of study drug.
|
XR-NTX+PN
n=50 participants at risk
Long-acting naltrexone (XR-NTX) and assignment of a patient navigator (PN).
|
ETAU
n=48 participants at risk
Treatment as usual, along with will receive drug education.
|
|---|---|---|---|
|
General disorders
Pain at injection site
|
3.8%
2/53 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
8.0%
4/50 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
0.00%
0/48 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
|
Injury, poisoning and procedural complications
Precipitated withdrawal
|
1.9%
1/53 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
2.0%
1/50 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
0.00%
0/48 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
|
Eye disorders
photophobia
|
1.9%
1/53 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
0.00%
0/50 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
0.00%
0/48 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
|
Eye disorders
Blurred vision
|
1.9%
1/53 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
0.00%
0/50 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
0.00%
0/48 • 6 months for participants in either of the two medication conditions.
AEs were systematically collected from participants in the two medication conditions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place