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CompletedNCT01648270Updated Jan 22, 2020Results posted

Buprenorphine Disposition and Cyclosporine

An interventional study of buprenorphine in Healthy, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-22.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
25
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The determine the effect of cyclosporine on buprenorphine disposition

Read the detailed description

Subjects studied on four occasions:

  1. Intravenous buprenorphine
  2. Sublingual buprenorphine
  3. Cyclosporine, then intravenous buprenorphine. Subjects then take oral cyclosporine twice daily, until
  4. Sublingual buprenorphine; continue oral cyclosporine twice daily for 5 days
02

Conditions studied

  • Healthy

Keywords

  • buprenorphine
  • CYP3A
03

In context

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 271 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.

Browse Washington University School of Medicine studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18-50 yr old
  • Good general health with no remarkable medical conditions
  • BMI \< 33
  • Provide informed consent

Exclusion criteria

Exclusion Criteria:

  • Known history of liver or kidney disease
  • Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affecting CYP3A
  • Females who are pregnant or nursing
  • Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
  • Direct physical access to and routine handling of addicting drugs in the regular course of duty (a routine exclusion from studies of drugs with addiction potential)
05

Study design

Phase
Not applicable
Primary purpose
Other
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Study Arm

    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

    Drug: buprenorphine

Interventions

  • Drugbuprenorphine

    Session 1 Intravenous buprenorphine: 0.2 mg over 1 hr Session 2 Sublingual buprenorphine: 2 mg Session 3 Intravenous buprenorphine 0.2 mg over 1 hr beginning 1 hr after starting cyclosporine Session 4 Sublingual buprenorphine: 2 mg after cyclosporine.

06

What researchers measure

Primary outcomes

  1. Buprenorphine Plasma Cmax

    Time frame: 96 hours

07

Results

Posted Jan 22, 2020

Participant flow

Intravenous Buprenorphine
Participant flow — Intravenous Buprenorphine
MilestoneBuprenorphine
Started25
Completed13
Not completed12
Withdrew: Withdrawal by subject12
Sublingual Buprenorphine
Participant flow — Sublingual Buprenorphine
MilestoneBuprenorphine
Started13
Completed13
Not completed0
Cyclosporine Plus IV Buprenorphine
Participant flow — Cyclosporine Plus IV Buprenorphine
MilestoneBuprenorphine
Started13
Completed13
Not completed0
Cyclosporine + Sublingual Buprenorphine
Participant flow — Cyclosporine + Sublingual Buprenorphine
MilestoneBuprenorphine
Started13
Completed13
Not completed0

Outcome measures

PrimaryBuprenorphine Plasma Cmax
Time frame:
96 hours

No measurements were reported for this outcome.

Adverse events

Collected over Up to 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intravenous Buprenorphine0/18 (0%)0/18 (0%)16/18 (88.9%)
Sublingual Buprenorphine0/18 (0%)0/18 (0%)17/18 (94.4%)
Cyclosporine Plus Intravenous Buprenorphine0/18 (0%)0/18 (0%)17/18 (94.4%)
Cyclosporine Plus Sublingual Buprenorphine0/18 (0%)0/18 (0%)18/18 (100%)
Most frequent other events
Most frequent other events
EventIntravenous BuprenorphineSublingual BuprenorphineCyclosporine Plus Intravenous BuprenorphineCyclosporine Plus Sublingual Buprenorphine
itchGeneral disorders12/1814/188/1811/18
nauseaGastrointestinal disorders10/1813/1810/189/18
OtherProduct Issues2/181/1810/185/18
HeadacheNervous system disorders6/183/182/184/18
DizzynessNervous system disorders4/185/183/181/18

Baseline characteristics

Age, Continuous
Age, Continuous(years)Study Arm
Mean29 ± 7
Sex: Female, Male
Sex: Female, Male(Participants)Study Arm
Female5
Male8
08

Study locations

1 site
  • Washington University School of Medicine
    St Louis, Missouri 63012, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2012, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2020, 3 years 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2012
First posted
Jul 24, 2012
Start
Apr 2012
Primary completionActual
Dec 2016
CompletionActual
Dec 2016
Results first posted
Jan 22, 2020
Last update
Jan 22, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01648270
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Jul 24, 2012
Start date
Apr 2012
Primary completion
Dec 2016
Completion
Dec 2016
Results posted
Jan 22, 2020
Last update
Jan 22, 2020

Study contacts

Evan Kharasch, MD, PhD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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