Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

ConditionsOpioid Withdrawal Opioid Use Disorder Opioid Craving

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Maryland, Baltimore

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years - 65 year old

Opioid-positive urine sample

Current opioid use disorder with evidence of physical dependence

Interest in undergoing opioid taper

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 1 treatment group

Group A: Within-subject designOther 4 interventions

Trial outcomes

Primary outcomes

Withdrawal severity during lofexidine taper

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

Time frame

Days 6 through 10

Withdrawal severity during naloxone challenge

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).

Time frame

Days 1 through 5

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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