Buprenorphine Induction for Fentanyl Dependent Opioid Users

NCT04794790 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: STUDY00016153
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this pilot study is to characterize illicit fentanyl and combination fentanyl and opioid dependence explicitly, by assessing physiologic barriers to effective buprenorphine induction. Results from this pilot study may make a case for a larger feasibility study to be conducted through the Clinical Trials Network at the National Institutes of Drug Abuse. The primary hypothesis is that individuals dependent on illicit fentanyl and combination fentanyl and opioids will have difficulty with standard buprenorphine induction, and will need a modified approach. The primary outcome measure will be retention on buprenorphine at seven days post induction. The secondary outcome measures will be objective precipitated withdrawal and the rate of patients requiring or requesting to initiate methadone due to intolerance of buprenorphine.

Conditions

Opioid Dependence Fentanyl

Outcome Measures

Primary Outcomes (1)

• Number of patients on Buprenorphine at the end of 7 day induction period

  Number of patients who are able and willing to receive a prescription for Buprenorphine at the end of a 7 day induction period. This will be measured by manual counts. The patient will be scored as 0 (for not able/willing to receive a prescription for bup) or 1 (for able/willing to receive a prescription for bup)

  7 days

Secondary Outcomes (1)

• Opioid withdrawal assessment

  7 days

Other Outcomes (1)

• Attrition rate measures

  7 days

Study Arms (3)

Standard Dose

NO INTERVENTION

Standard dose induction Visit 1 Day 1 (intake/baseline) Participants will commence induction with a dose of 4mg if COWS is above 7. If COWS is below 7, participant will be instructed to return the next day, so that COWS can be above 7 to start the study.

Macro or High Dose

EXPERIMENTAL

Macro or High Dosing Visit 1 Day 1 (intake/baseline) Participants will commence induction with a dose of 4mg if COWS is above 7. If COWS is below 7, participant will be instructed to return the next day, so that COWS can be above 7 to start the study. (These participants can still be in the study and will only have to re-do a baseline COW's on the day they come back to the clinic, which will then be considered their day 1).

Drug: Buprenorphine/naloxone

Micro or Low Dose

EXPERIMENTAL

Micro or Low Dose Visit 1 Day 1 (intake/baseline) Participants will commence induction with a dose of 4mg if COWS is above 7. If COWS is below 7, participant will be instructed to return the next day, so that COWS can be above 7 to start the study. (These participants can still be in the study and will only have to re-do a baseline COW's on the day they come back to the clinic, which will then be considered their day 1).

Drug: Buprenorphine/naloxone

Interventions

Buprenorphine/naloxone DRUG

Buprenorphine/Naloxone induction via a standard dose protocol

Macro or High Dose; Micro or Low Dose

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Diagnosis of opioid use disorder (OUD) as determined through routine clinical care
• Positive for fentanyl on point of care urine drug screen
• Ability to read, write, and comprehend English
• Patients willing to start buprenorphine at the onset of treatment (e.g., clinical intake)
• Patients who need to initiate a buprenorphine induction at home must have an operating smartphone or tablet device with video capability.

You may not qualify if:

• Initiating maintenance treatment that does not include MAT or switching to a maintenance treatment that does not include MAT (i.e.: detoxification and counseling treatment only without MAT, or planning to enter methadone treatment).
• Judged by the evaluating physician or allied clinician to need a higher level of care (i.e.: residential or inpatient treatment)
• Pregnant
• Patients desiring to start methadone or naltrexone at the onset of treatment (e.g., clinical intake)
• Patients who are unable to stay in the clinic for the induction period.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

The Pennsylvania Psychiatric Institute

Harrisburg, Pennsylvania, 17110, United States

Location

Related Publications (3)

• Mars SG, Rosenblum D, Ciccarone D. Fentanyl: the many challenges ahead. Addiction. 2019 May;114(5):785-786. doi: 10.1111/add.14587. Epub 2019 Mar 15. No abstract available.

  PMID: 30873700 BACKGROUND

• Silverstein SM, Daniulaityte R, Martins SS, Miller SC, Carlson RG. "Everything is not right anymore": Buprenorphine experiences in an era of illicit fentanyl. Int J Drug Policy. 2019 Dec;74:76-83. doi: 10.1016/j.drugpo.2019.09.003. Epub 2019 Sep 25.

  PMID: 31563098 BACKGROUND

• Hser YI, Saxon AJ, Huang D, Hasson A, Thomas C, Hillhouse M, Jacobs P, Teruya C, McLaughlin P, Wiest K, Cohen A, Ling W. Treatment retention among patients randomized to buprenorphine/naloxone compared to methadone in a multi-site trial. Addiction. 2014 Jan;109(1):79-87. doi: 10.1111/add.12333. Epub 2013 Oct 9.

  PMID: 23961726 BACKGROUND

MeSH Terms

Interventions

Buprenorphine, Naloxone Drug Combination

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry and Behavioral Health

Model Details: We are attempting to characterize the particular problem of prolonged precipitated withdrawal in individuals with fentanyl dependence through a quasi-experimental study, which will enroll 20 to 30 individuals at the PPI OTP, who are using fentanyl and/or combination of fentanyl and opioids but desiring buprenorphine naloxone induction. There will be a standard treatment arm, then a micro dose and macro dose arm.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 12, 2021
• Study Start: May 9, 2022
• Primary Completion: February 22, 2024
• Study Completion: June 22, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

US (1)