Healthy VolunteersNCT01648283
CYP2B6 Polymorphisms in Methadone Disposition
A study testing IV racemic methadone HCl and Oral racemic methadone HCl in people with Healthy Volunteers, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes methadone. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- IV racemic methadone HCl and Oral racemic methadone HCl
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Each subject must meet all of the following criteria:
- 18-50 yr old
- CYP2B6*1/*1, CYP2B6*1/*6 or CYP2B6*6/*6 genotype
- Good general health with no remarkable medical conditions
- BMI < 33
- Provided informed consent
Who cannot join
- Subjects will not be enrolled if any of the following criteria exist:
- Known history of liver or kidney disease
- Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affect CYP2B6
- 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 (this is a routine exclusion from studies of drugs with addiction potential)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Schoool of Medicine
St Louis, Missouri, 63110
About this study
Official title: Role of CYP2B6 Polymorphisms in Methadone Metabolism and Clearance
This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes methadone.
Read the detailed description
This investigation determined the influence of CYP2B6 genetic variation, specifically CYP2B6*6 polymorphism, on clinical methadone plasma concentrations, clearance, and metabolism. The hypothesis was that CYP2B6*6 heterozygotes or homozygotes would have reduced metabolism and clearance. A secondary objective was to evaluate other less common genotypic variants, when encountered. Healthy volunteers in genotype cohorts CYP2B6*1/*1, CYP2B6*1/*6 , and CYP2B6*6/*6, and also CYP2B6*4 and CYP2B6*5 carriers, received single doses of IV and oral methadone. Plasma and urine methadone and metabolite concentrations were determined by tandem mass spectrometry. The primary outcome measure was methadone metabolism, measured as plasma metabolite/patent area under the concentration-time curve ratio and metabolite formation clearance.
- Conditions
- Healthy Volunteers
- Being tested
- IV racemic methadone HCl, Oral racemic methadone HCl
- Keywords
- methadone polymorphisms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV racemic methadone HClDrug
IV racemic Methadone HC1 6 mg
Oral racemic methadone HClDrug
oral d5-methadone HCl 11 mg
| Study group | Role | What they receive |
|---|---|---|
| Methadone arm | Experimental | 1. Intravenous racemic methadone HCl, 6.0 mg bolus
2. Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511) Receives: Drug: IV racemic methadone HCl; Drug: Oral racemic methadone HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methadone Metabolism
Plasma metabolite EDDP/methadone area under the concentration-time curve (AUC0-96) ratio
Measured: up to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evan Kharasch, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648283
- Sponsor's protocol ID
- 201203105
- Status last verified
- Jun 2018
- First submitted
- 6 Jun 2012
- Last updated
- 20 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kharasch ED, Regina KJ, Blood J, Friedel C. Methadone Pharmacogenetics: CYP2B6 Polymorphisms Determine Plasma Concentrations, Clearance, and Metabolism. Anesthesiology. 2015 Nov;123(5):1142-53. doi: 10.1097/ALN.0000000000000867.
PubMed 26389554
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of CYP2B6 Polymorphisms in Methadone Metabolism and Clearance
- ClinicalTrials.gov ID
- NCT01648283
- Acronym / sponsor ID
- 201203105
- Conditions
- Healthy Volunteers
- Keywords
- methadone polymorphisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Posted 20 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes methadone.
Detailed description
This investigation determined the influence of CYP2B6 genetic variation, specifically CYP2B6*6 polymorphism, on clinical methadone plasma concentrations, clearance, and metabolism. The hypothesis was that CYP2B6*6 heterozygotes or homozygotes would have reduced metabolism and clearance. A secondary objective was to evaluate other less common genotypic variants, when encountered. Healthy volunteers in genotype cohorts CYP2B6*1/*1, CYP2B6*1/*6 , and CYP2B6*6/*6, and also CYP2B6*4 and CYP2B6*5 carriers, received single doses of IV and oral methadone. Plasma and urine methadone and metabolite concentrations were determined by tandem mass spectrometry. The primary outcome measure was methadone metabolism, measured as plasma metabolite/patent area under the concentration-time curve ratio and metabolite formation clearance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methadone arm | Experimental | Drug: IV racemic methadone HCl, Drug: Oral racemic methadone HCl1. Intravenous racemic methadone HCl, 6.0 mg bolus 2. Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-50 yr old
- CYP2B6*1/*1, CYP2B6*1/*6 or CYP2B6*6/*6 genotype
- Good general health with no remarkable medical conditions
- BMI < 33
- Provided informed consent
Key exclusion criteria (6 listed)
- Known history of liver or kidney disease
- Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affect CYP2B6
- 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 (this is a routine exclusion from studies of drugs with addiction potential)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV racemic methadone HClIV racemic Methadone HC1 6 mg | Drug | Methadone arm |
| Oral racemic methadone HCloral d5-methadone HCl 11 mg | Drug | Methadone arm |
Primary outcome
Methadone Metabolism
Time frame: up to 96 hours
Plasma metabolite EDDP/methadone area under the concentration-time curve (AUC0-96) ratio
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26389554Kharasch ED, Regina KJ, Blood J, Friedel C. Methadone Pharmacogenetics: CYP2B6 Polymorphisms Determine Plasma Concentrations, Clearance, and Metabolism. Anesthesiology. 2015 Nov;123(5):1142-53. doi: 10.1097/ALN.0000000000000867.
Related trials for Healthy Volunteers
RecruitingObservational study
Adaptive Optics Retinal Imaging
Eye Diseases, Healthy Volunteers
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Kharasch, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV racemic methadone HCl and Oral racemic methadone HCl in people with Healthy Volunteers, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methadone Metabolism (time frame: up to 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01648283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018; AzTrials last refreshed its copy on 28 Oct 2026.