Trial Outcomes & Findings for CYP2B6 Polymorphisms in Methadone Disposition (NCT NCT01648283)
NCT ID: NCT01648283
Last Updated: 2018-06-20
Results Overview
Plasma metabolite EDDP/methadone area under the concentration-time curve (AUC0-96) ratio
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
up to 96 hours
Results posted on
2018-06-20
Participant Flow
11 subject withdrawals following consent due to personal reasons and/or conflicts, 3 subjects not evaluable, 64 subjects evaluable and included in analysis
Participant milestones
| Measure |
Methadone Arm
1. Intravenous racemic methadone HCl, 6.0 mg bolus
2. Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511) CYP2B6 is phenotyped by the clearance oral racemic bupropion 150mg
racemic methadone HC1: IV racemic Methadone HC1 6 mg oral d5-methadon HC1 11 mg
Oral deuterated racemic methadone HCl,: 11 mg capsule once
|
|---|---|
|
Overall Study
STARTED
|
78
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Methadone Arm
1. Intravenous racemic methadone HCl, 6.0 mg bolus
2. Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511) CYP2B6 is phenotyped by the clearance oral racemic bupropion 150mg
racemic methadone HC1: IV racemic Methadone HC1 6 mg oral d5-methadon HC1 11 mg
Oral deuterated racemic methadone HCl,: 11 mg capsule once
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
Baseline Characteristics
CYP2B6 Polymorphisms in Methadone Disposition
Baseline characteristics by cohort
| Measure |
Methadone Arm
n=64 Participants
1. Intravenous racemic methadone HCl, 6.0 mg bolus
2. Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511) CYP2B6 is phenotyped by the clearance oral racemic bupropion 150mg
racemic methadone HC1: IV racemic Methadone HC1 6 mg oral d5-methadon HC1 11 mg
Oral deuterated racemic methadone HCl,: 11 mg capsule once
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 96 hoursPopulation: Plasma EDDP/methadone AUC ratio
Plasma metabolite EDDP/methadone area under the concentration-time curve (AUC0-96) ratio
Outcome measures
| Measure |
CYP2B6*1/*1
n=21 Participants
Oral R-methadone HCl
|
CYP2B6*1/*6
n=20 Participants
Oral R-methadone
|
CYP2B6*6/*6
n=17 Participants
Oral R-methadone
|
|---|---|---|---|
|
Methadone Metabolism
|
0.082 ratio
Standard Deviation 0.022
|
0.073 ratio
Standard Deviation 0.026
|
0.054 ratio
Standard Deviation 0.017
|
Adverse Events
Methadone Arm
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Methadone Arm
n=67 participants at risk
1. Intravenous racemic methadone HCl, 6.0 mg bolus
2. Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511) CYP2B6 is phenotyped by the clearance oral racemic bupropion 150mg
racemic methadone HC1: IV racemic Methadone HC1 6 mg oral d5-methadon HC1 11 mg
Oral deuterated racemic methadone HCl,: 11 mg capsule once
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
62.7%
42/67 • Number of events 42
|
|
General disorders
Headache
|
22.4%
15/67 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Itching
|
38.8%
26/67 • Number of events 26
|
|
General disorders
Dizzyness
|
38.8%
26/67 • Number of events 26
|
|
General disorders
syncope
|
1.5%
1/67 • Number of events 1
|
|
General disorders
feeling "hyperactive"
|
1.5%
1/67 • Number of events 1
|
|
General disorders
light senstivity
|
1.5%
1/67
|
Additional Information
Evan D. Kharasch, MD, PhD
Washington University School of Medicine
Phone: 314-362-8796
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place