Assessment of Methadone and Buprenorphine in Interstitial Fluid

NCT05546229 | Completed Results

• 2 other identifiers: 13323565R44DA044905-03
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to determine if common medications for opioid use disorder (i.e., buprenorphine/naloxone, buprenorphine, methadone) and their metabolites (norbuprenorphine \[a metabolite of buprenorphine\], buprenorphine-3-glucuronide \[B3G; a metabolite in buprenorphine\], ethylidene dimethyl diphenyl pyrrolidine \[EDDP; a metabolite of methadone\]) can be detected in the dermal interstitial fluid (i.e., fluid extracted from the surface of the skin). Additional subjects who are not prescribed or taking any of these medications will be included in this study to act as a comparison group

Conditions

Opioid Use Disorder

Keywords

methadone; buprenorphine; interstitial fluid

Outcome Measures

Primary Outcomes (3)

• Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose

  ISF collected from the surface of the skin along with blood plasma by venipuncture will be tested for methadone using LC-MS analysis.

  1 day

• Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a 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.

  1 day

• Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone

  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 .

  1 day

Secondary Outcomes (3)

• Pearson Correlation for Methadone Levels in ISF and Blood

  1 day

• Pearson Correlation Coefficient for Methadone Metabolite / EDDP Levels in ISF and Blood

  1 day

• Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken

  1 day

Study Arms (3)

Controls

Subjects not taking medications for opioid use disorder

Procedure: Microneedle based interstitial fluid collection

Methadone

Subjects taking methadone for opioid use disorder

Procedure: Microneedle based interstitial fluid collection

Buprenorphine

Subjects taking buprenorphine for opioid use disorder

Procedure: Microneedle based interstitial fluid collection

Interventions

Microneedle based interstitial fluid collection PROCEDURE

Interstitial fluid will be collected from the skin using microneedles and suction.

Buprenorphine; Controls; Methadone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving medication assisted treatment for opioid use disorder and control subjects not receiving any treatment for this condition.

You may qualify if:

• Age 18-65.
• A prescription for buprenorphine at dose ≥ 16 mg/4mg, a prescription for buprenorphine/naloxone at dose ≥ 16 mg/4mg, a prescription for methadone at dose ≥ 60mg, or part of the control group.
• Taken buprenorphine, buprenorphine/naloxone, or methadone as prescribed in the last 7 days, or part of the control group

You may not qualify if:

• A condition preventing or complicating ISF collection. Conditions may include dermatological (skin) condition, immunodeficiency, recent blood donation, anemia, cancer, congestive heart failure, HIV, Hepatitis C \[HCV\], or tuberculosis \[TB\].
• Any active severe depression (e.g., suicidal ideation) or mania symptoms.
• Lactation, pregnancy, or intending to become pregnant during the course of the study.
• Alcohol use in the past 7 days.
• Illicit substance use in past 7 days (e.g., heroin, methamphetamines).
• Under a conservatorship.

Sponsors & Collaborators

• Cari Health Inc.: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Synergy San Diego

Lemon Grove, California, 91945, United States

Location

Related Links

• Cari Health Inc.

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Difficulty recruiting subjects taking 16 mg or more of buprenorphine. Buprenorphine study group limited to 2 instead of the goal of 10 subjects. Data on buprenorphine reported as area under the curve and reading less than the level of detection for the assay reported as 0. Subject taking gabapentin 800mg 3 times a day was excluded from analysis of the correlation of blood and isf levels due to known drug-drug interaction with methadone.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Cari Health Inc.

drcarr@carihealth.com

619 2343725

Study Officials

• Mohammad Bari, MD

  Synergy San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 19, 2022
• Study Start: September 14, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: June 28, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)