Trial Outcomes & Findings for Buprenorphine Disposition and Cyclosporine (NCT NCT01648270)
NCT ID: NCT01648270
Last Updated: 2020-01-22
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
96 hours
Results posted on
2020-01-22
Participant Flow
Participant milestones
| Measure |
Buprenorphine
Subjects will be studied on four occasions. Sessions and drugs are:
1. Intravenous buprenorphine
2. Sublingual buprenorphine
3. Cyclosporine plus intravenous buprenorphine
4. Cyclosporine plus sublingual buprenorphine
|
|---|---|
|
Intravenous Buprenorphine
STARTED
|
25
|
|
Intravenous Buprenorphine
COMPLETED
|
13
|
|
Intravenous Buprenorphine
NOT COMPLETED
|
12
|
|
Sublingual Buprenorphine
STARTED
|
13
|
|
Sublingual Buprenorphine
COMPLETED
|
13
|
|
Sublingual Buprenorphine
NOT COMPLETED
|
0
|
|
Cyclosporine Plus IV Buprenorphine
STARTED
|
13
|
|
Cyclosporine Plus IV Buprenorphine
COMPLETED
|
13
|
|
Cyclosporine Plus IV Buprenorphine
NOT COMPLETED
|
0
|
|
Cyclosporine + Sublingual Buprenorphine
STARTED
|
13
|
|
Cyclosporine + Sublingual Buprenorphine
COMPLETED
|
13
|
|
Cyclosporine + Sublingual Buprenorphine
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Buprenorphine
Subjects will be studied on four occasions. Sessions and drugs are:
1. Intravenous buprenorphine
2. Sublingual buprenorphine
3. Cyclosporine plus intravenous buprenorphine
4. Cyclosporine plus sublingual buprenorphine
|
|---|---|
|
Intravenous Buprenorphine
Withdrawal by Subject
|
12
|
Baseline Characteristics
Buprenorphine Disposition and Cyclosporine
Baseline characteristics by cohort
| Measure |
Study Arm
n=13 Participants
Subjects will be studied on four occasions. Sessions and drugs are:
1. Intravenous buprenorphine
2. Sublingual buprenorphine
3. Cyclosporine plus intravenous buprenorphine
4. Cyclosporine plus sublingual buprenorphine
|
|---|---|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 96 hoursPopulation: 0 Participants Analyzed. The PI has left the institution. Sincere efforts were made to contact the PI but were unsuccessful. No study data are available.
Outcome measures
Outcome data not reported
Adverse Events
Intravenous Buprenorphine
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Sublingual Buprenorphine
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Cyclosporine Plus Intravenous Buprenorphine
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Cyclosporine Plus Sublingual Buprenorphine
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intravenous Buprenorphine
n=18 participants at risk
Intravenous buprenorphine: 0.2 mg infused over 1 hr
|
Sublingual Buprenorphine
n=18 participants at risk
Sublingual buprenorphine: 2 mg
|
Cyclosporine Plus Intravenous Buprenorphine
n=18 participants at risk
Cyclosporine (2.5mg/kg/hr infused over 2 hr), then intravenous buprenor-phine 0.2 mg infused over 1 hr beginning 1 hr after starting cyclosporine. Subjects then take oral cyclosporine 4.5 mg/kg twice daily
|
Cyclosporine Plus Sublingual Buprenorphine
n=18 participants at risk
Sublingual buprenorphine: 2 mg; continue oral cyclosporine 4.5 mg/kg twice daily for 5 days
|
|---|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
55.6%
10/18 • Number of events 10 • Up to 12 weeks
|
72.2%
13/18 • Number of events 13 • Up to 12 weeks
|
55.6%
10/18 • Number of events 10 • Up to 12 weeks
|
50.0%
9/18 • Number of events 9 • Up to 12 weeks
|
|
General disorders
itch
|
66.7%
12/18 • Number of events 12 • Up to 12 weeks
|
77.8%
14/18 • Number of events 14 • Up to 12 weeks
|
44.4%
8/18 • Number of events 8 • Up to 12 weeks
|
61.1%
11/18 • Number of events 11 • Up to 12 weeks
|
|
Nervous system disorders
Headache
|
33.3%
6/18 • Number of events 6 • Up to 12 weeks
|
16.7%
3/18 • Number of events 3 • Up to 12 weeks
|
11.1%
2/18 • Number of events 2 • Up to 12 weeks
|
22.2%
4/18 • Number of events 4 • Up to 12 weeks
|
|
Nervous system disorders
Dizzyness
|
22.2%
4/18 • Number of events 4 • Up to 12 weeks
|
27.8%
5/18 • Number of events 5 • Up to 12 weeks
|
16.7%
3/18 • Number of events 3 • Up to 12 weeks
|
5.6%
1/18 • Number of events 1 • Up to 12 weeks
|
|
Product Issues
Other
|
11.1%
2/18 • Number of events 2 • Up to 12 weeks
|
5.6%
1/18 • Number of events 1 • Up to 12 weeks
|
55.6%
10/18 • Number of events 10 • Up to 12 weeks
|
27.8%
5/18 • Number of events 5 • Up to 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place