Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
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
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
Treatments tested in this trial
- Hydromorphone
- Naloxone + lofexidine pretreatment
- Naloxone + placebo pretreatment
- Lofexidine
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Maryland, Baltimore
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov