Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder

Opioid Use Disorder Clinical Trial

Official title:

Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04234191
• Other study ID #: H19-03254
• Status: Recruiting
• Phase: Phase 2
• Start date: August 18, 2021
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: University of British Columbia
• Contact: Pouya Azar, MD, FRCPC, DABAM
• Phone: 604-875-4111
• Email: pouya.rezazadeh-azar[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current first-line treatment for opioid use disorder (OUD) in Canada is buprenorphine/naloxone (bup/nx). The standard induction method of bup/nx requires patients to be abstinent from opioids and thereby experience withdrawal symptoms prior to induction, which can be a major barrier in starting treatment. Rapid micro-induction (also known as micro-dosing, low-dose induction) involves the administration of small, frequent does of bup/nx and removes the need for a period of withdrawal prior to the start of treatment. This study aims to compare the effectiveness and safety of rapid micro-induction versus standard induction of bup/nx in patients with OUD.

Description:

This is a randomized, controlled, open-label superiority trial involving 50 individuals with OUD. Participants will be randomized into two arms: rapid micro-induction and standard induction (based on the American Society of Addiction Medicine Practice Guidelines and product monograph) of bup/nx.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Opioid Use Disorder (OUD) as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria;

2. Individuals seeking Opioid Agonist Treatment (OAT);

3. Be 19 years of age or older;

4. Be willing and able to adhere to the study protocol and follow-up schedule;

5. Be able to provide written informed consent to participate in the clinical trial.

6. If female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study.

Exclusion Criteria:

1. Diagnosis of severe medical or psychiatric conditions contraindicated for buprenorphine/naloxone or hydromorphone treatment;

2. Anticipated deterioration of health due to discontinuation of medications that are contraindicated with buprenorphine/naloxone and/or hydromorphone;

3. Positive pregnancy test for women of childbearing potential;

4. Methadone use in the past 5 days;

5. Buprenorphine use in the past 5 days;

6. Known allergy or sensitivity to buprenorphine/naloxone and/or hydromorphone;

7. Anticipation that the patient may need to initiate pharmacological treatment during the trial that is deemed unsafe by the study physician or could prevent study completion;

8. Unwilling or unable to use an effective method of birth control approved by the study investigators throughout the study.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• Buprenorphine/naloxone
Buprenorphine/naloxone is an opioid agonist treatment for opioid use disorder. It is administered via sublingual tablet form.
• Hydromorphone
Hydromorphone is an opioid used for managing pain, craving, and withdrawal. It is administered orally via tablet or liquid form; or administered intravenously, subcutaneously, or intramuscularly via liquid form.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Hammig R, Kemter A, Strasser J, von Bardeleben U, Gugger B, Walter M, Dursteler KM, Vogel M. Use of microdoses for induction of buprenorphine treatment with overlapping full opioid agonist use: the Bernese method. Subst Abuse Rehabil. 2016 Jul 20;7:99-105. doi: 10.2147/SAR.S109919. eCollection 2016. — View Citation

Kampman K, Jarvis M. American Society of Addiction Medicine (ASAM) National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use. J Addict Med. 2015 Sep-Oct;9(5):358-67. doi: 10.1097/ADM.0000000000000166. — View Citation

Klaire S, Zivanovic R, Barbic SP, Sandhu R, Mathew N, Azar P. Rapid micro-induction of buprenorphine/naloxone for opioid use disorder in an inpatient setting: A case series. Am J Addict. 2019 Jul;28(4):262-265. doi: 10.1111/ajad.12869. Epub 2019 Mar 22. — View Citation

Sandhu R, Zivanovic R, Klaire S, Nikoo M, Rozylo J, Azar P. Buprenorphine/naloxone induction for treatment of acute on chronic pain using a micro-dosing regimen: A case report. Can J Pain. 2019 Apr 25;3(1):79-84. doi: 10.1080/24740527.2019.1599279. eCollection 2019. — View Citation

Vogel M, Kock P, Strasser J, Wiesbeck G, Walter M, Dursteler KM. Chronic High-Dose Buprenorphine Does Not Block Subjective High from Diacetylmorphine in a Patient in Heroin-Assisted Treatment. J Psychoactive Drugs. 2019 Sep-Oct;51(4):377-382. doi: 10.1080/02791072.2019.1610200. Epub 2019 May 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful induction of bup/nx with low levels of withdrawal	This is defined as the following: participants who remain in treatment until they have received a total daily dose of = 8mg of bup/nx (successful induction), and score = 12 on the COWS (low levels of withdrawal) from baseline to when they reach that dose.	Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm)
Secondary	Illicit drug use	Assessed by urine drug screens (UDS) and Treatment Outcomes Profile (TOP).	Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm)
Secondary	Drug use behaviour	Assessed by the Treatment Outcomes Profile (TOP).	Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm)
Secondary	Treatment retention	Participants who pick up their prescription of bup/nx on Day 7. Assessed via the pharmacy database.	Day 7
Secondary	Craving	Assessed by the numeric craving scale.	Baseline to Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm)
Secondary	Pain	Assessed by the numeric pain scale.	Baseline to Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm)
Secondary	Physical health	Assessed by the health section of the Opiate Treatment Index (OTI).	Baseline (both arms)
Secondary	Client satisfaction	Assessed by the Treatment Perceptions Questionnaire (TPQ).	Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm)
Secondary	Appearance of adverse events	Assessed by an adverse events report form.	Baseline to Day 1 (Standard induction Arm) or Day 2 (Rapid Micro-Induction Arm)