Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
University of Maryland, Baltimore
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.
Description
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 tap…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 w…
Interventions
- DrugHydromorphone
Up to 120mg oral per day in q4 dosing to manage withdrawal
- DrugNaloxone + 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)
- DrugNaloxone + placebo pretreatment
0.2-0.4mg naloxone injection during the Naloxone challenge
- DrugLofexidine
Oral Lofexidine dosed per FDA label (4 times daily) on days 6 through 10.
Location
- University of MarylandBaltimore, Maryland