Methadone Monitoring for Insights Into Adverse Events

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01191242

Acronym

MEMORIES

Enrollment

Registered

2010-08-30

Start date

2010-08-31

Completion date

2011-05-31

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opiate Addiction, Pain

Keywords

methadone, genetic

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Methadone Maintenance Observation Group A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.	31
Total	31

Baseline characteristics

Characteristic	Methadone Maintenance Observation Group
Age, Continuous	30.3 years STANDARD_DEVIATION 9.9
Race/Ethnicity, Customized African American	1 Participants
Race/Ethnicity, Customized Caucasian	23 Participants
Race/Ethnicity, Customized Hispanic	6 Participants
Race/Ethnicity, Customized Native American	1 Participants
Region of Enrollment United States	31 Participants
Sex: Female, Male Female	11 Participants
Sex: Female, Male Male	20 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 0
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0