Clinical trial NCT05027919: Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
Official title: Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Opioid Withdrawal
Opioid Use Disorder
Opioid Craving
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

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

Primary outcomes:
measure: Withdrawal severity during lofexidine taper
timeFrame: Days 6 through 10
measure: Withdrawal severity during naloxone challenge
timeFrame: Days 1 through 5
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University Bayview Medical Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kelly E Dunn, Ph.D, M.B.A.
role: PRINCIPAL_INVESTIGATOR
References: