Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydromorphone, Naloxone + lofexidine pretreatment, Naloxone + placebo pretreatment, Lofexidine.
- Who it may be relevant to
- Registry conditions: Opioid Withdrawal, Opioid Use Disorder, Opioid Craving. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Evaluate individual differences in the expression of opioid withdrawal symptoms in persons with opioid use disorder (OUD) while completing a clinically-indicated medication taper.
Detailed 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 tapered off of morphine using lofexidine (as clinically indicated). At the end of the study all participants will be able to transition to buprenorphine maintenance or receive oral naltrexone and an injection of Vivitrol (extended release naltrexone), consistent with standard of care practices. Investigators will collect a variety of biological samples and questionnaire ratings during the study and primary outcomes will be measures of withdrawal collected throughout the study. Investigators will use these data to learn more about why individuals express opioid withdrawal symptoms differently, which will help inform how to change current treatment practices to be more effective for persons with OUD.
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.
Primary outcome measures
- Withdrawal severity during lofexidine taper [Time frame: Days 6 through 10]
- Withdrawal severity during naloxone challenge [Time frame: Days 1 through 5]
Eligibility criteria
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 with liver function tests outside the normal range (persons with a positive hepatitis C antibody and normal liver functions tests are NOT excluded from the study)
- Significant mental health or physical disorder, or life circumstances, that is expected to interfere with study participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Maryland — Baltimore
Identifiers
NCT: NCT05027919 · IRB00279895 · 1R01DA052937