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Alpha-2 Adrenergic Receptor Agonist

Opioid Withdrawal Management for Opioid Use Disorder

Phase 2
Recruiting
Led By Kelly E Dunn, Ph.D, M.B.A.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years - 65 year old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 6 through 10
Awards & highlights

Study Summary

This trial will evaluate how different people experience opioid withdrawal symptoms when tapering off medication, in order to better understand and treat opioid use disorder.

Who is the study for?
This trial is for adults aged 18-65 with opioid use disorder who are physically dependent on opioids and interested in tapering off. It's not for those dependent on alcohol or benzodiazepines, pregnant or breastfeeding women, people on methadone/buprenorphine treatment, or those with significant heart issues, mental health disorders, active hepatitis B/C infections with abnormal liver tests.Check my eligibility
What is being tested?
The study is testing how different treatments affect opioid withdrawal symptoms during a medication taper. Treatments include Naloxone combined with a placebo or lofexidine (a non-opioid medication), and Morphine as comparisons to understand individual responses to withdrawal.See study design
What are the potential side effects?
Possible side effects may include low blood pressure and slow heart rate from lofexidine; nausea, vomiting, sweating from naloxone-induced withdrawal; and typical opioid side effects like drowsiness and constipation from morphine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 6 through 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 6 through 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Withdrawal severity during lofexidine taper
Naloxone

Trial Design

1Treatment groups
Experimental Treatment
Group I: Within-subject designExperimental Treatment4 Interventions
All participants will undergo the same study design, which includes morphine stabilization (days 1-5), two naloxone challenges (scheduled during morphine stabilization), lofexidine-assisted taper (days 6-10), and transition to aftercare (day 11).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Morphine
2013
Completed Phase 4
~2230
Lofexidine
2010
Completed Phase 4
~1100

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,823,161 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,670 Total Patients Enrolled
Kelly E Dunn, Ph.D, M.B.A.Principal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Lofexidine (Alpha-2 Adrenergic Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05027919 — Phase 2
Opioid Use Disorder Research Study Groups: Within-subject design
Opioid Use Disorder Clinical Trial 2023: Lofexidine Highlights & Side Effects. Trial Name: NCT05027919 — Phase 2
Lofexidine (Alpha-2 Adrenergic Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027919 — Phase 2

Frequently Asked Questions

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

What are the common reasons why this medication is given to patients?

"Buprenorphine is most often used to manage opioid addiction. That said, it can also help to alleviate pain, pruritus, and septic shock."

Answered by AI

Is this a new treatment or has it been studied before?

"At the moment, there are one hundred and six ongoing trials researching this treatment. Out of those, 27 are in Phase 3. The majority of these trials are centred in Boston, but there are 269 locations in total running these studies."

Answered by AI

Has this medication been federally sanctioned?

"While Phase 2 trials don't have data supporting efficacy, there is some evidence backing the safety of this treatment. Therefore, it received a score of 2."

Answered by AI

For individuals that are in their 70s, does this research study still accept participants?

"The inclusion criteria for this study requires that participants are above the age of 18 and below the age of 65."

Answered by AI

If a patient were interested, could they presently enroll in this clinical trial?

"The trial, which is still recruiting patients, was first posted on February 1st, 2022 and has had an 18 February update according to the clinicaltrials.gov website."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
Johns Hopkins University Bayview Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
2022. "Assessing a Clinically-meaningful Opioid Withdrawal Phenotype". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05027919.
~25 spots leftby Nov 2025
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