PainMEMORIESNCT01191242

Methadone Monitoring for Insights Into Adverse Events

An observational study of Pain and Opiate Addiction, run by Intermountain Health Care, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Opiate Addiction
How many people: 31 participants
Where: 2 sitesUnited States
Study dates: Aug 2010to May 2011
Phase: Observational
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects initiating methadone treatment for opioid addiction who meet elibitility criteria.

Who may be able to join

must be 18 years of age or older; eligible for methadone treatment as judged by Discovery House criteria
must sign informed consent for methadone treatment prior to being approached for this study
must sign a written informed consent for this study
is willing and has a means to return for all scheduled follow-up visits

Who cannot join

pregnancy, participation in any other clinical trial involving investigational or marketed products with 30 days prior to entry into this study; current use of an inducer/inhibitor of known enzymes involved with methadone metabolism
use of methadone in the 30 days prior to study enrollment; concomitant use of QT prolonging drugs
considered by the treatment physician to be ineligible for methadone treatment; hepatic function panel indicates chronic liver disease.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Intermountain Medical Center
Murray, Utah, 84107
Discovery House
Taylorsville, Utah, 84123

Other trials in United States

About this study

Methadone has been an effective and inexpensive therapy in the management of chronic pain and opioid dependence. However it has been associated with sudden, unexpected deaths. Two mechanisms have been suggested, increased drug concentration in the blood, and a change in the heart rhythm. This study will look at blood samples for drug levels and genetic components and EKG's (a noninvasive test which reveals heart rhythm). There will be no intervention.

Conditions: Pain, Opiate Addiction
Keywords: methadone, genetic
Medical subject headings: Pain, Opioid-Related Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Methadone Peak Plasma Concentration
Measured: Day 1, Day 7, Day 21
Total Methadone Trough Plasma Concentration
Measured: Day 1, Day 7, Day 21
(S)- Methadone Peak Plasma Concentration
Measured: Day 1, Day 7, Day 21
(S)- Methadone Trough Plasma Concentration
Measured: Day 1, Day 7, Day 21
(R)-Methadone Peak Plasma Concentration
Measured: Day 1, Day 7, Day 21
(R)-Methadone Trough Plasma Concentration
Measured: Day 1, Day 7, Day 21
Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration
Measured: Day 1, Day 7, Day 21
Total EDDP Trough Plasma Concentration
Measured: Day 1, Day 7, Day 21
(S)-EDDP Peak Plasma Concentration
Measured: Day 1, Day 7, Day 21
(S)-EDDP Trough Plasma Concentration
Measured: Day 1, Day 7, Day 21
(R)-EDDP Peak Plasma Concentration
Measured: Day 1, Day 7, Day 21
(R)-EDDP Trough Plasma Concentration
Measured: Day 1, Day 7, Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010May 2011

First posted30 Aug 2010 (estimated)
Study startAug 2010
Primary completionMar 2011
Study completionMay 2011

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 PainStudies of the same condition, open and under way.
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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01191242
Sponsor's protocol ID: 154-08
Acronym: MEMORIES
Status last verified: Apr 2012
First submitted: 17 Aug 2010
Last updated: 29 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Carlquist JF, Moody DE, Knight S, Johnson EG, Fang WB, Huntinghouse JA, Rollo JS, Webster LR, Anderson JL. A Possible Mechanistic Link Between the CYP2C19 Genotype, the Methadone Metabolite Ethylidene-1,5-Dimethyl-3,3-Diphenylpyrrolidene (EDDP), and Methadone-Induced Corrected QT Interval Prolongation in a Pilot Study. Mol Diagn Ther. 2015 Apr;19(2):131-8. doi: 10.1007/s40291-015-0137-4.
PubMed 25903311

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Methadone Monitoring for Insights Into Adverse Events
ClinicalTrials.gov ID: NCT01191242
Acronym / sponsor ID: MEMORIES / 154-08
Conditions: Pain, Opiate Addiction
Keywords: methadone, genetic
Study type: Observational
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Intermountain Health Care, Inc.University, hospital or other
Study start: Aug 2010
Primary completion: Mar 2011 (actual)
Study completion: May 2011 (actual)
First posted: 30 Aug 2010 (estimated)
Results: Posted 17 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects initiating methadone treatment for opioid addiction who meet elibitility criteria.

Key inclusion criteria (4 listed)

must be 18 years of age or older; eligible for methadone treatment as judged by Discovery House criteria
must sign informed consent for methadone treatment prior to being approached for this study
must sign a written informed consent for this study
is willing and has a means to return for all scheduled follow-up visits

Key exclusion criteria (3 listed)

pregnancy, participation in any other clinical trial involving investigational or marketed products with 30 days prior to entry into this study; current use of an inducer/inhibitor of known enzymes involved with methadone metabolism
use of methadone in the 30 days prior to study enrollment; concomitant use of QT prolonging drugs
considered by the treatment physician to be ineligible for methadone treatment; hepatic function panel indicates chronic liver disease.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Total Methadone Peak Plasma Concentration
Time frame: Day 1, Day 7, Day 21
Total Methadone Trough Plasma Concentration
Time frame: Day 1, Day 7, Day 21
(S)- Methadone Peak Plasma Concentration
Time frame: Day 1, Day 7, Day 21
(S)- Methadone Trough Plasma Concentration
Time frame: Day 1, Day 7, Day 21
(R)-Methadone Peak Plasma Concentration
Time frame: Day 1, Day 7, Day 21
(R)-Methadone Trough Plasma Concentration
Time frame: Day 1, Day 7, Day 21
Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration
Time frame: Day 1, Day 7, Day 21
Total EDDP Trough Plasma Concentration
Time frame: Day 1, Day 7, Day 21
(S)-EDDP Peak Plasma Concentration
Time frame: Day 1, Day 7, Day 21
(S)-EDDP Trough Plasma Concentration
Time frame: Day 1, Day 7, Day 21
(R)-EDDP Peak Plasma Concentration
Time frame: Day 1, Day 7, Day 21
(R)-EDDP Trough Plasma Concentration
Time frame: Day 1, Day 7, Day 21

Results and safety

Results posted to the registry on 17 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Methadone Maintenance Observation Group	31	31

Primary outcome: Total Methadone Peak Plasma Concentration

Time frame: Day 1, Day 7, Day 21. Mean (Standard Deviation). Unit: ng/mL

Measure	Methadone Maintenance Observation Group n = 31
Day 1	107.3 (50.6)
Day 7	315.4 (129.6)
Day 21	362.2 (213.1)

Primary outcome: Total Methadone Trough Plasma Concentration

Time frame: Day 1, Day 7, Day 21. Mean (Standard Deviation). Unit: ng/mL

Measure	Methadone Maintenance Observation Group n = 31
Day 1	53.0 (27.3)
Day 7	162.6 (68.5)
Day 21	211.1 (119.5)

Primary outcome: (S)- Methadone Peak Plasma Concentration

Time frame: Day 1, Day 7, Day 21. Mean (Standard Deviation). Unit: ng/mL

Measure	Methadone Maintenance Observation Group n = 31
Day 1	65.6 (29.9)
Day 7	178.8 (76.9)
Day 21	215.1 (103.1)

Primary outcome: (S)- Methadone Trough Plasma Concentration

Time frame: Day 1, Day 7, Day 21. Mean (Standard Deviation). Unit: ng/mL

Measure	Methadone Maintenance Observation Group n = 31
Day 1	32.2 (14.4)
Day 7	84.2 (39.5)
Day 21	106.1 (60.1)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Methadone Maintenance Observation Group	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): The principal limitations are small sample size and the limited number of genetic variants tested. Also, study endpoints were not examined beyond 21 days of treatment; thus the durability of study findings over longer time periods is not known.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25903311Carlquist JF, Moody DE, Knight S, Johnson EG, Fang WB, Huntinghouse JA, Rollo JS, Webster LR, Anderson JL. A Possible Mechanistic Link Between the CYP2C19 Genotype, the Methadone Metabolite Ethylidene-1,5-Dimethyl-3,3-Diphenylpyrrolidene (EDDP), and Methadone-Induced Corrected QT Interval Prolongation in a Pilot Study. Mol Diagn Ther. 2015 Apr;19(2):131-8. doi: 10.1007/s40291-015-0137-4.

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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.

John F Carlquist, PhD principal investigator

Intermountain Health Care, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pain and Opiate Addiction, run by Intermountain Health Care, Inc. at 2 sites 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 4 inclusion and 3 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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 17 Feb 2017). 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?

Total Methadone Peak Plasma Concentration (time frame: Day 1, Day 7, Day 21). The study lists 12 primary outcomes in all. 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 NCT01191242, 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 29 Mar 2017.