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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.
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| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects initiating methadone treatment for opioid addiction who meet elibitility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| John F Carlquist, PhD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84107 | United States | ||
| Discovery House |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25903311 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methadone Maintenance Observation Group | A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methadone Maintenance Observation Group | A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Methadone Peak Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 7, Day 21 |
|
|
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All-cause mortality, serious, and other (not including serious) adverse events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methadone Maintenance Observation Group | A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Carlquist, PhD | Intermountain Heart Institute | 8014081028 | 74707 | john.carlquist@imail.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
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Plasma and DNA
| (R)-EDDP Trough Plasma Concentration | Day 1, Day 7, Day 21 |
| Taylorsville |
| Utah |
| 84123 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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| Primary | Total Methadone Trough Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 7, Day 21 |
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| Primary | (S)- Methadone Peak Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 7, Day 21 |
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| Primary | (S)- Methadone Trough Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 7, Day 21 |
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| Primary | (R)-Methadone Peak Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 7, Day 21 |
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| Primary | (R)-Methadone Trough Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 7, Day 21 |
|
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| Primary | Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 7, Day 21 |
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| Primary | Total EDDP Trough Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 7, Day 21 |
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| Primary | (S)-EDDP Peak Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 7, Day 21 |
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| Primary | (S)-EDDP Trough Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 7, Day 21 |
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| Primary | (R)-EDDP Peak Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 7, Day 21 |
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| Primary | (R)-EDDP Trough Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 7, Day 21 |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |