NCT05027919View on ClinicalTrials.gov

Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

November 30, 2026

Study Completion Date

February 28, 2027

Conditions
Opioid WithdrawalOpioid Use DisorderOpioid Craving
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.

Trial Locations (1)

21201

RECRUITING

University of Maryland, Baltimore

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

University of Maryland, Baltimore

OTHER