Trial Outcomes & Findings for Methadone Monitoring for Insights Into Adverse Events (NCT NCT01191242)

NCT ID: NCT01191242

Last Updated: 2017-03-29

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 31 participants
• Primary outcome timeframe: Day 1, Day 7, Day 21
• Results posted on: 2017-03-29

Participant Flow

Participant milestones

Measure	Methadone Maintenance Observation Group A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
Overall Study STARTED	31
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Methadone Monitoring for Insights Into Adverse Events

Baseline characteristics by cohort

Measure	Methadone Maintenance Observation Group n=31 Participants A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
Age, Continuous	30.3 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	23 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants
Region of Enrollment United States	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, Day 7, Day 21

Outcome measures

Measure	Methadone Maintenance Observation Group n=31 Participants A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
Total Methadone Peak Plasma Concentration Day 1	107.3 ng/mL Standard Deviation 50.6
Total Methadone Peak Plasma Concentration Day 7	315.4 ng/mL Standard Deviation 129.6
Total Methadone Peak Plasma Concentration Day 21	362.2 ng/mL Standard Deviation 213.1

PRIMARY outcome

Timeframe: Day 1, Day 7, Day 21

Outcome measures

Measure	Methadone Maintenance Observation Group n=31 Participants A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
Total Methadone Trough Plasma Concentration Day 1	53.0 ng/mL Standard Deviation 27.3
Total Methadone Trough Plasma Concentration Day 7	162.6 ng/mL Standard Deviation 68.5
Total Methadone Trough Plasma Concentration Day 21	211.1 ng/mL Standard Deviation 119.5

PRIMARY outcome

Timeframe: Day 1, Day 7, Day 21

Outcome measures

Measure	Methadone Maintenance Observation Group n=31 Participants A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
(S)- Methadone Peak Plasma Concentration Day 1	65.6 ng/mL Standard Deviation 29.9
(S)- Methadone Peak Plasma Concentration Day 7	178.8 ng/mL Standard Deviation 76.9
(S)- Methadone Peak Plasma Concentration Day 21	215.1 ng/mL Standard Deviation 103.1

PRIMARY outcome

Timeframe: Day 1, Day 7, Day 21

Outcome measures

Measure	Methadone Maintenance Observation Group n=31 Participants A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
(S)- Methadone Trough Plasma Concentration Day 1	32.2 ng/mL Standard Deviation 14.4
(S)- Methadone Trough Plasma Concentration Day 7	84.2 ng/mL Standard Deviation 39.5
(S)- Methadone Trough Plasma Concentration Day 21	106.1 ng/mL Standard Deviation 60.1

PRIMARY outcome

Timeframe: Day 1, Day 7, Day 21

Outcome measures

Measure	Methadone Maintenance Observation Group n=31 Participants A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
(R)-Methadone Peak Plasma Concentration Day 1	41.8 ng/mL Standard Deviation 21.1
(R)-Methadone Peak Plasma Concentration Day 7	136.6 ng/mL Standard Deviation 55.3
(R)-Methadone Peak Plasma Concentration Day 21	178.6 ng/mL Standard Deviation 90.8

PRIMARY outcome

Timeframe: Day 1, Day 7, Day 21

Outcome measures

Measure	Methadone Maintenance Observation Group n=31 Participants A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
(R)-Methadone Trough Plasma Concentration Day 1	23.0 ng/mL Standard Deviation 11.8
(R)-Methadone Trough Plasma Concentration Day 7	78.4 ng/mL Standard Deviation 31.8
(R)-Methadone Trough Plasma Concentration Day 21	105.0 ng/mL Standard Deviation 61.4

PRIMARY outcome

Timeframe: Day 1, Day 7, Day 21

Outcome measures

Measure	Methadone Maintenance Observation Group n=31 Participants A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration Day 1	11.0 ng/mL Standard Deviation 8.6
Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration Day 7	39.8 ng/mL Standard Deviation 33.4
Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration Day 21	45.3 ng/mL Standard Deviation 27.0

PRIMARY outcome

Timeframe: Day 1, Day 7, Day 21

Outcome measures

Measure	Methadone Maintenance Observation Group n=31 Participants A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
Total EDDP Trough Plasma Concentration Day 1	4.8 ng/mL Standard Deviation 4.5
Total EDDP Trough Plasma Concentration Day 7	17.7 ng/mL Standard Deviation 10.0
Total EDDP Trough Plasma Concentration Day 21	26.6 ng/mL Standard Deviation 16.7

PRIMARY outcome

Timeframe: Day 1, Day 7, Day 21

Outcome measures

Measure	Methadone Maintenance Observation Group n=31 Participants A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
(S)-EDDP Peak Plasma Concentration Day 7	20.6 ng/mL Standard Deviation 15.5
(S)-EDDP Peak Plasma Concentration Day 21	30.3 ng/mL Standard Deviation 19.0
(S)-EDDP Peak Plasma Concentration Day 1	5.8 ng/mL Standard Deviation 3.8

PRIMARY outcome

Timeframe: Day 1, Day 7, Day 21

Outcome measures

Measure	Methadone Maintenance Observation Group n=31 Participants A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
(S)-EDDP Trough Plasma Concentration Day 1	3.8 ng/mL Standard Deviation 2.3
(S)-EDDP Trough Plasma Concentration Day 7	9.1 ng/mL Standard Deviation 6.7
(S)-EDDP Trough Plasma Concentration Day 21	13.7 ng/mL Standard Deviation 9.4

PRIMARY outcome

Timeframe: Day 1, Day 7, Day 21

Outcome measures

Measure	Methadone Maintenance Observation Group n=31 Participants A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
(R)-EDDP Peak Plasma Concentration Day 1	3.4 ng/mL Standard Deviation 3.1
(R)-EDDP Peak Plasma Concentration Day 7	13.5 ng/mL Standard Deviation 10.3
(R)-EDDP Peak Plasma Concentration Day 21	18.2 ng/mL Standard Deviation 9.0

PRIMARY outcome

Timeframe: Day 1, Day 7, Day 21

Outcome measures

Measure	Methadone Maintenance Observation Group n=31 Participants A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
(R)-EDDP Trough Plasma Concentration Day 1	1.2 ng/mL Standard Deviation 1.7
(R)-EDDP Trough Plasma Concentration Day 7	6.6 ng/mL Standard Deviation 3.7
(R)-EDDP Trough Plasma Concentration Day 21	10.5 ng/mL Standard Deviation 6.9

Adverse Events

Methadone Maintenance Observation Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Carlquist, PhD

Intermountain Heart Institute

Phone: 8014081028

Email: john.carlquist@imail.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place