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NCT Number: NCT05027919

Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

Evaluate individual differences in the expression of opioid withdrawal symptoms in persons with opioid use disorder (OUD) while completing a clinically-indicated medication taper.

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Key information

Conditions

Opioid Withdrawal Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Craving Opioid Use Disorder Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Maryland

Baltimore, Maryland, 21201, United States

Location status: Recruiting

Location contact

Kelly E Dunn, PhD, MBA

CONTACT

[email protected]

802-922-1682

Kelly E Dunn, PhD, MBA

PRINCIPAL_INVESTIGATOR

About this study

Individuals who have opioid use disorder and are interested in being tapered off of opioids will be admitted to a residential research unit for an 11-day period. All participants will be maintained on morphine for 5 days. During this period participants will complete 2 sessions (on two different days) wherein participants will receive an intramuscular injection of naloxone to precipitate a short withdrawal syndrome. Participants will take a capsule prior to both sessions that will contain either placebo or the opioid withdrawal medication lofexidine. Beginning on day 6 participants will be tapered off of morphine using lofexidine (as clinically indicated). At the end of the study all participants will be able to transition to buprenorphine maintenance or receive oral naltrexone and an injection of Vivitrol (extended release naltrexone), consistent with standard of care practices. Investigators will collect a variety of biological samples and questionnaire ratings during the study and primary outcomes will be measures of withdrawal collected throughout the study. Investigators will use these data to learn more about why individuals express opioid withdrawal symptoms differently, which will help inform how to change current treatment practices to be more effective for persons with OUD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years - 65 year old
  • Opioid-positive urine sample
  • Current opioid use disorder with evidence of physical dependence
  • Interest in undergoing opioid taper

Exclusion criteria

  • Evidence of physical dependence on alcohol or benzodiazepines that requires medical intervention
  • Being pregnant or breastfeeding
  • Enrolled in methadone or buprenorphine maintenance treatment
  • Clinically significant hypotension (<90/60mmHg) or bradycardia (<45bpm)
  • History of myocardial infarction
  • Subjects who are positive for hepatitis B surface antigen and/or hepatitis C antibody with liver function tests outside the normal range (persons with a positive hepatitis C antibody and normal liver functions tests are NOT excluded from the study)
  • Significant mental health or physical disorder, or life circumstances, that is expected to interfere with study participation

Treatment and study plan

Hydromorphone

Drug

Up to 120mg oral per day in q4 dosing to manage withdrawal

Naloxone + lofexidine pretreatment

Drug

0.2-0.4mg naloxone injection during the Naloxone challenge + pretreatment with oral lofexidine (25% of max daily dose scheduled during lofexidine taper)

Naloxone + placebo pretreatment

Drug

0.2-0.4mg naloxone injection during the Naloxone challenge

Lofexidine

Drug

Oral Lofexidine dosed per FDA label (4 times daily) on days 6 through 10.

Primary outcomes

  1. Withdrawal severity during lofexidine taper

    Time frame: Days 6 through 10

    Withdrawal severity as assessed by the Subjective Opioid Withdrawal Scale. (The score range is 0 through 64) with higher score indicating more severe withdrawal.

  2. Withdrawal severity during naloxone challenge

    Time frame: Days 1 through 5

    Withdrawal severity as assessed by the Subjective Opioid Withdrawal scale scores (The range is 0 through 64) with higher score indicating more severe withdrawal. Collected during two naloxone challenges (pretreatment with lofexidine and pretreatment with placebo).

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly E Dunn, Ph.D, M.B.A.

CONTACT

[email protected]

802-922-1682

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Aug 31, 2021
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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