Trial Outcomes & Findings for Assessment of Methadone and Buprenorphine in Interstitial Fluid (NCT NCT05546229)
NCT ID: NCT05546229
Last Updated: 2023-06-28
Results Overview
ISF collected from the surface of the skin along with blood plasma by venipuncture will be tested for methadone using LC-MS analysis.
COMPLETED
11 participants
1 day
2023-06-28
Participant Flow
15 patients recruited. 4 patients not eligible do to screening results that resulted in exclusion based on documented exclusion criteria. 1 extra control recruited instead of expected 2 due to initial 2 controls both of the same sex and the desire to have at least one female and one male control
Participant milestones
| Measure |
Controls
Subjects not taking medications for opioid use disorder
Microneedle based interstitial fluid collection: Interstitial fluid will be collected from the skin using microneedles and suction.
|
Methadone
Subjects taking methadone for opioid use disorder
Microneedle based interstitial fluid collection: Interstitial fluid will be collected from the skin using microneedles and suction.
|
Buprenorphine
Subjects taking buprenorphine for opioid use disorder
Microneedle based interstitial fluid collection: Interstitial fluid will be collected from the skin using microneedles and suction.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
2
|
|
Overall Study
COMPLETED
|
3
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Controls
n=3 Participants
Subjects not taking medications for opioid use disorder
Microneedle based interstitial fluid collection: Interstitial fluid will be collected from the skin using microneedles and suction.
|
Methadone
n=6 Participants
Subjects taking methadone for opioid use disorder
Microneedle based interstitial fluid collection: Interstitial fluid will be collected from the skin using microneedles and suction.
|
Buprenorphine
n=2 Participants
Subjects taking buprenorphine for opioid use disorder
Microneedle based interstitial fluid collection: Interstitial fluid will be collected from the skin using microneedles and suction.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
10 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
6 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
6 participants
n=6 Participants
|
2 participants
n=2 Participants
|
11 participants
n=11 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Patients that met the inclusion and exclusion criteria of the study. Only the methadone taking cohort included in this measure. Data collected prior to daily dose of methadone and 3 Hours after taking daily dose of methadone.
ISF collected from the surface of the skin along with blood plasma by venipuncture will be tested for methadone using LC-MS analysis.
Outcome measures
| Measure |
Plasma Level of Methadone Prior to Daily Dose of Methadone
n=6 Participants
Plasma level of methadone from patient treated with methadone for opioid use disorder: Plasma is collected by venipuncture prior to subject taking their daily dose of greater than or equal to 60 mg methadone.
|
Plasma Level of Methadone 3 Hours After Taking Daily Dose
n=6 Participants
Measure methadone levels in plasma 3 hours after taking daily dose of 60 mg or more of methadone
|
Interstitial Fluid Level of Methadone Pre Dose
n=6 Participants
Measurement of methadone from microneedle-based collection of interstitial fluid prior to daily dose of methadone.
|
Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose
n=6 Participants
Measurement of interstitial fluid level of methadone 3 hours after taking daily dose
|
|---|---|---|---|---|
|
Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose
Participant E
|
796 ng/ml
|
831 ng/ml
|
4300 ng/ml
|
5800 ng/ml
|
|
Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose
Participant C
|
96 ng/ml
|
353 ng/ml
|
990 ng/ml
|
1200 ng/ml
|
|
Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose
Participant D
|
330 ng/ml
|
526 ng/ml
|
1700 ng/ml
|
3300 ng/ml
|
|
Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose
Participant F
|
207 ng/ml
|
382 ng/ml
|
420 ng/ml
|
1300 ng/ml
|
|
Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose
Participant A
|
565 ng/ml
|
640 ng/ml
|
760 ng/ml
|
2000 ng/ml
|
|
Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose
Participant B
|
240 ng/ml
|
441 ng/ml
|
14319 ng/ml
|
17418 ng/ml
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Patients that met the inclusion and exclusion criteria of the study. Only methadone taking cohort included in this measure, including patient taking gabapentin. Data collected prior to daily dose of Methadone and 3 hours after taking daily dose of methadone.
Plasma and ISF collected from the surface of the skin will be tested for methadone metabolite /eddp using LC-MS analysis. Detection will be performed before and 3 hours after taking prescribed dose of methadone.
Outcome measures
| Measure |
Plasma Level of Methadone Prior to Daily Dose of Methadone
n=6 Participants
Plasma level of methadone from patient treated with methadone for opioid use disorder: Plasma is collected by venipuncture prior to subject taking their daily dose of greater than or equal to 60 mg methadone.
|
Plasma Level of Methadone 3 Hours After Taking Daily Dose
n=6 Participants
Measure methadone levels in plasma 3 hours after taking daily dose of 60 mg or more of methadone
|
Interstitial Fluid Level of Methadone Pre Dose
n=6 Participants
Measurement of methadone from microneedle-based collection of interstitial fluid prior to daily dose of methadone.
|
Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose
n=6 Participants
Measurement of interstitial fluid level of methadone 3 hours after taking daily dose
|
|---|---|---|---|---|
|
Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone
Patient A
|
135 ng/ml
|
137 ng/ml
|
260 ng/ml
|
400 ng/ml
|
|
Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone
Patient B
|
10 ng/ml
|
38 ng/ml
|
290 ng/ml
|
370 ng/ml
|
|
Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone
Patient C
|
21 ng/ml
|
41 ng/ml
|
14 ng/ml
|
62 ng/ml
|
|
Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone
Patient D
|
45 ng/ml
|
40.5 ng/ml
|
0 ng/ml
|
76 ng/ml
|
|
Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone
Patient E
|
54 ng/ml
|
57 ng/ml
|
0 ng/ml
|
280 ng/ml
|
|
Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone
Patient F
|
46 ng/ml
|
74 ng/ml
|
98 ng/ml
|
120 ng/ml
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Patients not taking methadone that met the inclusion and exclusion criteria of the study. Includes only control and buprenorphine (BUP) cohorts.
Plasma collected from subjects not taking methadone by venipuncture and ISF collected from the surface of the skin. Samples tested for methadone and methadone metabolite /eddp using Liquid Chromatography-Mass Spec (LC-MS) analysis .
Outcome measures
| Measure |
Plasma Level of Methadone Prior to Daily Dose of Methadone
n=5 Participants
Plasma level of methadone from patient treated with methadone for opioid use disorder: Plasma is collected by venipuncture prior to subject taking their daily dose of greater than or equal to 60 mg methadone.
|
Plasma Level of Methadone 3 Hours After Taking Daily Dose
n=5 Participants
Measure methadone levels in plasma 3 hours after taking daily dose of 60 mg or more of methadone
|
Interstitial Fluid Level of Methadone Pre Dose
n=5 Participants
Measurement of methadone from microneedle-based collection of interstitial fluid prior to daily dose of methadone.
|
Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose
n=5 Participants
Measurement of interstitial fluid level of methadone 3 hours after taking daily dose
|
|---|---|---|---|---|
|
Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone
Patient Control 1
|
0 ng/ml
|
0 ng/ml
|
0 ng/ml
|
0 ng/ml
|
|
Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone
Patient Control 2
|
0 ng/ml
|
0 ng/ml
|
0 ng/ml
|
0 ng/ml
|
|
Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone
Patient Control 3
|
0 ng/ml
|
0 ng/ml
|
0 ng/ml
|
0 ng/ml
|
|
Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone
Patient Bup 1
|
0 ng/ml
|
0 ng/ml
|
0 ng/ml
|
0 ng/ml
|
|
Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone
Patient Bup 2
|
0 ng/ml
|
0 ng/ml
|
0 ng/ml
|
0 ng/ml
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Patients that met the criteria for inclusion and lacked exclusions as per protocol. We also excluded one patient that was taking 800mg of gabapentin qid due to the known effect of gabapentin on methadone clearance and drug-drug interactions. Only methadone taking cohort included in this measure.
The Pearson correlation coefficient of blood and ISF methadone levels was calculated using the Least Squared Method from Microsoft Excel software.
Outcome measures
| Measure |
Plasma Level of Methadone Prior to Daily Dose of Methadone
n=5 Participants
Plasma level of methadone from patient treated with methadone for opioid use disorder: Plasma is collected by venipuncture prior to subject taking their daily dose of greater than or equal to 60 mg methadone.
|
Plasma Level of Methadone 3 Hours After Taking Daily Dose
Measure methadone levels in plasma 3 hours after taking daily dose of 60 mg or more of methadone
|
Interstitial Fluid Level of Methadone Pre Dose
Measurement of methadone from microneedle-based collection of interstitial fluid prior to daily dose of methadone.
|
Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose
Measurement of interstitial fluid level of methadone 3 hours after taking daily dose
|
|---|---|---|---|---|
|
Pearson Correlation for Methadone Levels in ISF and Blood
|
.805 Pearson Correlation Coefficient
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Patients that met the criteria for inclusion and lacked exclusions as per protocol. We also excluded one patient that was taking 800mg of gabapentin qid due to the known effect of gabapentin on methadone clearance and drug-drug interactions. Only methadone taking cohort included in this data.
The Pearson correlation coefficient between the ISF and blood levels of EDDP were calculated using the Least Squared Method by Microsoft Excel software.
Outcome measures
| Measure |
Plasma Level of Methadone Prior to Daily Dose of Methadone
n=5 Participants
Plasma level of methadone from patient treated with methadone for opioid use disorder: Plasma is collected by venipuncture prior to subject taking their daily dose of greater than or equal to 60 mg methadone.
|
Plasma Level of Methadone 3 Hours After Taking Daily Dose
Measure methadone levels in plasma 3 hours after taking daily dose of 60 mg or more of methadone
|
Interstitial Fluid Level of Methadone Pre Dose
Measurement of methadone from microneedle-based collection of interstitial fluid prior to daily dose of methadone.
|
Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose
Measurement of interstitial fluid level of methadone 3 hours after taking daily dose
|
|---|---|---|---|---|
|
Pearson Correlation Coefficient for Methadone Metabolite / EDDP Levels in ISF and Blood
|
.84 Pearson Correlation Coefficient
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Patients on 16mg or more of buprenorphine for Opioid Use Disorder. Only the buprenorphine taking cohort included in this outcome measure.
Plasma collected by venipuncture and ISF collected from the surface of the skin will be tested for buprenorphine using LC-MS analysis before and after a dose of buprenorphine has been taken
Outcome measures
| Measure |
Plasma Level of Methadone Prior to Daily Dose of Methadone
n=2 Participants
Plasma level of methadone from patient treated with methadone for opioid use disorder: Plasma is collected by venipuncture prior to subject taking their daily dose of greater than or equal to 60 mg methadone.
|
Plasma Level of Methadone 3 Hours After Taking Daily Dose
n=2 Participants
Measure methadone levels in plasma 3 hours after taking daily dose of 60 mg or more of methadone
|
Interstitial Fluid Level of Methadone Pre Dose
n=2 Participants
Measurement of methadone from microneedle-based collection of interstitial fluid prior to daily dose of methadone.
|
Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose
n=2 Participants
Measurement of interstitial fluid level of methadone 3 hours after taking daily dose
|
|---|---|---|---|---|
|
Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken
Participant G
|
2339 ng/ml
|
22459 ng/ml
|
6509 ng/ml
|
0 ng/ml
|
|
Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken
Participant H
|
0 ng/ml
|
15663 ng/ml
|
0 ng/ml
|
0 ng/ml
|
Adverse Events
Controls
Methadone
Buprenorphine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place