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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

Must not have

Evidence of physical dependence on alcohol or benzodiazepines that requires medical intervention

History of myocardial infarction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 6 through 10

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.

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.

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

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need medical help for my alcohol or benzodiazepine dependence.

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I have had a heart attack before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 6 through 10

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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