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Opioid Partial Agonist

Buprenorphine Induction for Opioid Dependence

Phase < 1
Recruiting
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients willing to start buprenorphine at the onset of treatment (e.g., clinical intake)
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Study Summary

This trial will help assess if people who are dependent on opioids, specifically fentanyl, will have difficulty being inducted onto buprenorphine. The primary outcome measure is retention on buprenorphine at seven days post induction, with secondary outcome measures of objective precipitated withdrawal and the rate of patients requiring or requesting to initiate methadone due to intolerance of buprenorphine.

Who is the study for?
This trial is for adults over 18 who test positive for fentanyl, can read and write English, are willing to start buprenorphine treatment, and have a smartphone or tablet with video capability. It's not for those unable to stay in the clinic during induction, seeking non-MAT treatments or higher care levels like residential treatment, pregnant women, or those wanting methadone/naltrexone initially.Check my eligibility
What is being tested?
The study tests how well people dependent on fentanyl respond to standard buprenorphine induction versus a modified approach. The main goal is seeing if they stick with buprenorphine after seven days. They'll also check for withdrawal symptoms and if patients switch to methadone due to not tolerating buprenorphine.See study design
What are the potential side effects?
Buprenorphine may cause side effects such as nausea, headaches, sweating, drug withdrawal syndrome (like shaking), insomnia (trouble sleeping), pain and tingling in limbs. Each person might experience these differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am willing to start buprenorphine at the beginning of my treatment.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients on Buprenorphine at the end of 7 day induction period
Secondary outcome measures
Opioid withdrawal assessment
Other outcome measures
Attrition rate measures

Side effects data

From 2010 Phase 4 trial • 1269 Patients • NCT00315341
48%
infections and infestations
41%
investigations
33%
gastrointestinal disorders
24%
injury, poisoning, and procedural complications
23%
nasopharyngitis
20%
nervous system disorders
19%
musculoskeletal and connective tissue disorders
17%
psychiatric disorders
16%
general disorders and administration site conditions
14%
skin and subcutaneous tissue disorders
13%
alanine aminotransferase increased
12%
aspartate aminotransferase increased
12%
respiratory, thoracic, and mediastinal disorders
11%
toothache
11%
gamma glutamyltransferase increased
10%
headache
9%
constipation
9%
hospitalization
7%
back pain
7%
hyperhidrosis
7%
influenza
6%
vomiting
5%
weight increased
5%
upper respiratory tract infection
1%
life-threatening
1%
disability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Methadone
Buprenorphine/Nx

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Micro or Low DoseExperimental Treatment1 Intervention
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).
Group II: Macro or High DoseExperimental Treatment1 Intervention
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).
Group III: Standard DoseActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buprenorphine/naloxone
2010
Completed Phase 4
~2460

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
491 Previous Clinical Trials
2,798,775 Total Patients Enrolled

Media Library

Buprenorphine/naloxone (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04794790 — Phase < 1
Opioid Dependence Research Study Groups: Micro or Low Dose, Standard Dose, Macro or High Dose
Opioid Dependence Clinical Trial 2023: Buprenorphine/naloxone Highlights & Side Effects. Trial Name: NCT04794790 — Phase < 1
Buprenorphine/naloxone (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04794790 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I join this clinical trial?

"Candidates between the age of majority and 99 who suffer from opioid addiction are invited to apply for this clinical trial. 30 individuals in total will be selected as test subjects."

Answered by AI

Are the slots for this research endeavor still accessible to participants?

"Patients looking to volunteer for this medical experiment can find relevant information on clinicaltrials.gov; the trial was initially published on May 9th 2022 and last revised on December 1st 2022."

Answered by AI

Does this experiment offer participation for individuals over the age of fifty?

"To qualify for inclusion, participants must meet the age range of 18-99. For patients outside this demographic, there are 26 research projects specifically targeting those under 18 and 286 studies centering on elderly individuals aged 65 and above."

Answered by AI

What medical symptoms can be treated by administering Buprenorphine/naloxone?

"Buprenorphine/naloxone is the preferred treatment for opioid addiction, and also has applications in treating pruritus, pain conditions, and septic shock."

Answered by AI

How many people are enrolled in this clinical research?

"Affirmative. As evidenced on the clinicaltrials.gov database, this research trial is currently recruiting patients who were initially posted by May 9th 2022 and last updated on December 1st 2022. A total of 30 participants are required across a single medical centre."

Answered by AI

Has Buprenorphine/naloxone been tested in previous clinical investigations?

"At present, there are 56 active Buprenorphine/naloxone trials with 13 of them in the final stage. Of all these studies, most are situated in Gainesville, Florida; however, a total of 236 sites across the USA are offering this drug to patients."

Answered by AI
~11 spots leftby Mar 2025