Search > Opioid Use Disorder
12 Participants NeededMy employer runs this trial

Naloxone and Buprenorphine for Opioid Use Disorder

Recruiting at 1 trial location
JW
Overseen ByJames Wong, MSc
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Pouya Azar
Must not be taking: Benzodiazepines, Naltrexone, CYP3A4 inhibitors, others
Disqualifiers: Severe medical conditions, Pregnancy, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical study is to evaluate a new treatment approach called symptom inhibited naloxone induction (SINI) for people with opioid use disorder. In this study, participants will receive small doses of intravenous (IV) naloxone at intervals until they feel mild opioid withdrawal symptoms. At this point, they will be given buprenorphine/naloxone under the tongue to help with the withdrawal symptoms. One hour after, they will receive a injection of long acting buprenorphine under the skin if they choose to.

The main questions this study aims to answer are:

Is it feasible to use the SINI protocol in inpatient and outpatient settings? Is the SINI protocol safe and tolerable for individuals with opioid use disorder?

Who Is on the Research Team?

PA

Pouya Azar, MD

Principal Investigator

Department of Psychiatry, Faculty of Medicine, University of British Columbia and Vancouver General Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

Participants must be willing and able to provide written informed consent for study participation
Participants must have opioid use disorder as confirmed by DSM 5 diagnostic criteria
Participants must be willing and able to have and maintain IV access for the duration of the SINI
See 4 more

Exclusion Criteria

Participants with known allergy or sensitivity to naloxone or buprenorphine will be excluded
I have not used BUP-XR in the past 43 weeks.
Participants who have used BUP/NLX within the past 9 days will be excluded
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Induction

Participants undergo symptom inhibited naloxone induction (SINI) to initiate buprenorphine/naloxone treatment

1 day
Inpatient visit

Treatment

Participants receive sublingual buprenorphine/naloxone and may opt for extended-release buprenorphine injection

1 day
Inpatient visit

Follow-up

Participants are monitored for safety, effectiveness, and retention on treatment

28 days
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Symptom-Inhibited Naloxone Induction (SINI)

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pouya Azar

Lead Sponsor

Trials
1
Recruited
50+

Vancouver General Hospital

Collaborator

Trials
42
Recruited
19,700+

VGH and UBC Hospital Foundation

Collaborator

Trials
4
Recruited
330+

British Columbia Centre for Excellence in HIV/AIDS

Collaborator

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