Opioid Use Disorder Clinical Trial
Official title:
Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
Evaluate individual differences in the expression of opioid withdrawal symptoms in persons with opioid use disorder (OUD) while completing a clinically-indicated medication taper.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | February 28, 2026 |
Est. primary completion date | November 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University Bayview Medical Campus | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Days 6 through 10 | |
Primary | 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). | Days 1 through 5 |
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