Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05027919
PHASE2

Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-12-01

Completion Date

2027-02-28

Last Updated

2025-09-12

Healthy Volunteers

No

Interventions

DRUG

Hydromorphone

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

DRUG

Naloxone + lofexidine pretreatment

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

DRUG

Naloxone + placebo pretreatment

0.2-0.4mg naloxone injection during the Naloxone challenge

DRUG

Lofexidine

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

Locations (1)

University of Maryland

Baltimore, Maryland, United States