Trial Outcomes & Findings for Remote Observed Dosing of Suboxone to Improve Clinical Practice (NCT NCT03769025)
NCT ID: NCT03769025
Last Updated: 2023-07-27
Results Overview
compare the mean urinary buprenorphine level obtained over 12 weeks between the two groups
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
Remote Observed Dosing
One group will be assigned to Remote Observed Dosing (ROD) and will have all of their Suboxone® doses remotely observed. The intervention is remote observed dosing
Suboxone Remote Observed Dosing: The remote observed dosing group will use the provided smartphone to video record themselves taking their Suboxone dose each day
|
Attention Control
The attention control (AC) group will not have their dosing observed but will send a text message confirming they have taken their study medication to the study team daily matching contact with the study team. Text message confirming that they have taken their study medication is the intervention
Suboxone Attention Control: Attention control group will send a text message daily confirming that they have taken their Suboxone dose
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Remote Observed Dosing
One group will be assigned to Remote Observed Dosing (ROD) and will have all of their Suboxone® doses remotely observed. The intervention is remote observed dosing
Suboxone Remote Observed Dosing: The remote observed dosing group will use the provided smartphone to video record themselves taking their Suboxone dose each day
|
Attention Control
The attention control (AC) group will not have their dosing observed but will send a text message confirming they have taken their study medication to the study team daily matching contact with the study team. Text message confirming that they have taken their study medication is the intervention
Suboxone Attention Control: Attention control group will send a text message daily confirming that they have taken their Suboxone dose
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
Baseline Characteristics
Remote Observed Dosing of Suboxone to Improve Clinical Practice
Baseline characteristics by cohort
| Measure |
Remote Observed Dosing
n=8 Participants
One group will be assigned to Remote Observed Dosing (ROD) and will have all of their Suboxone® doses remotely observed. The intervention is remote observed dosing
Suboxone Remote Observed Dosing: The remote observed dosing group will use the provided smartphone to video record themselves taking their Suboxone dose each day
|
Attention Control
n=8 Participants
The attention control (AC) group will not have their dosing observed but will send a text message confirming they have taken their study medication to the study team daily matching contact with the study team. Text message confirming that they have taken their study medication is the intervention
Suboxone Attention Control: Attention control group will send a text message daily confirming that they have taken their Suboxone dose
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
34 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
34 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 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
|
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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weekscompare the mean urinary buprenorphine level obtained over 12 weeks between the two groups
Outcome measures
| Measure |
Remote Observed Dosing
n=8 Participants
One group will be assigned to Remote Observed Dosing (ROD) and will have all of their Suboxone® doses remotely observed. The intervention is remote observed dosing
Suboxone Remote Observed Dosing: The remote observed dosing group will use the provided smartphone to video record themselves taking their Suboxone dose each day
|
Attention Control
n=8 Participants
The attention control (AC) group will not have their dosing observed but will send a text message confirming they have taken their study medication to the study team daily matching contact with the study team. Text message confirming that they have taken their study medication is the intervention
Suboxone Attention Control: Attention control group will send a text message daily confirming that they have taken their Suboxone dose
|
|---|---|---|
|
Mean Urinary Buprenorphine Levels
|
861 ng/ml
Standard Deviation 1656
|
287 ng/ml
Standard Deviation 253
|
SECONDARY outcome
Timeframe: 12 weeksPercent of urine drug screens positive for opiates
Outcome measures
| Measure |
Remote Observed Dosing
n=8 Participants
One group will be assigned to Remote Observed Dosing (ROD) and will have all of their Suboxone® doses remotely observed. The intervention is remote observed dosing
Suboxone Remote Observed Dosing: The remote observed dosing group will use the provided smartphone to video record themselves taking their Suboxone dose each day
|
Attention Control
n=8 Participants
The attention control (AC) group will not have their dosing observed but will send a text message confirming they have taken their study medication to the study team daily matching contact with the study team. Text message confirming that they have taken their study medication is the intervention
Suboxone Attention Control: Attention control group will send a text message daily confirming that they have taken their Suboxone dose
|
|---|---|---|
|
Percent of Urine Positive Drug Screens
|
.3 percent of urine positive drug screens
Standard Deviation .36
|
.29 percent of urine positive drug screens
Standard Deviation .49
|
Adverse Events
Remote Observed Dosing
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Attention Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Remote Observed Dosing
n=8 participants at risk
One group will be assigned to Remote Observed Dosing (ROD) and will have all of their Suboxone® doses remotely observed. The intervention is remote observed dosing
Suboxone Remote Observed Dosing: The remote observed dosing group will use the provided smartphone to video record themselves taking their Suboxone dose each day
|
Attention Control
n=8 participants at risk
The attention control (AC) group will not have their dosing observed but will send a text message confirming they have taken their study medication to the study team daily matching contact with the study team. Text message confirming that they have taken their study medication is the intervention
Suboxone Attention Control: Attention control group will send a text message daily confirming that they have taken their Suboxone dose
|
|---|---|---|
|
Endocrine disorders
Diabetic ketoacidosis
|
12.5%
1/8 • Number of events 1 • 12 week
|
0.00%
0/8 • 12 week
|
|
Renal and urinary disorders
nephrolithiasis
|
12.5%
1/8 • Number of events 1 • 12 week
|
0.00%
0/8 • 12 week
|
Other adverse events
| Measure |
Remote Observed Dosing
n=8 participants at risk
One group will be assigned to Remote Observed Dosing (ROD) and will have all of their Suboxone® doses remotely observed. The intervention is remote observed dosing
Suboxone Remote Observed Dosing: The remote observed dosing group will use the provided smartphone to video record themselves taking their Suboxone dose each day
|
Attention Control
n=8 participants at risk
The attention control (AC) group will not have their dosing observed but will send a text message confirming they have taken their study medication to the study team daily matching contact with the study team. Text message confirming that they have taken their study medication is the intervention
Suboxone Attention Control: Attention control group will send a text message daily confirming that they have taken their Suboxone dose
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
37.5%
3/8 • Number of events 3 • 12 week
|
25.0%
2/8 • Number of events 2 • 12 week
|
|
Skin and subcutaneous tissue disorders
flushing
|
12.5%
1/8 • Number of events 1 • 12 week
|
12.5%
1/8 • Number of events 1 • 12 week
|
|
Musculoskeletal and connective tissue disorders
arthralgias
|
50.0%
4/8 • Number of events 4 • 12 week
|
25.0%
2/8 • Number of events 2 • 12 week
|
|
General disorders
fatigue
|
12.5%
1/8 • Number of events 1 • 12 week
|
25.0%
2/8 • Number of events 2 • 12 week
|
|
Infections and infestations
upper respiratory infection
|
0.00%
0/8 • 12 week
|
25.0%
2/8 • Number of events 2 • 12 week
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • 12 week
|
25.0%
2/8 • Number of events 2 • 12 week
|
|
Skin and subcutaneous tissue disorders
edema
|
25.0%
2/8 • Number of events 2 • 12 week
|
0.00%
0/8 • 12 week
|
|
General disorders
drug withdrawal
|
25.0%
2/8 • Number of events 2 • 12 week
|
0.00%
0/8 • 12 week
|
|
Skin and subcutaneous tissue disorders
skin infection
|
25.0%
2/8 • Number of events 2 • 12 week
|
12.5%
1/8 • Number of events 1 • 12 week
|
Additional Information
Kyle M Kampman MD Principal Investigator
Perelman School of Medicine
Phone: 215 746 2764
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place