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Midwest Clinical Research Center
Opioid Withdrawal Case Study
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety, and Dose-Response Study of XXXXX in the Treatment of Opioid Withdrawal (Days 1-7) Followed by Open-Label, Variable Dose XXXXX Treatment (Days 8-14)
Key Elements
- Rescue Site
- High Enrollment
- Inpatient
60
Subjects
7 Days
Inpatient period
66
Vitals per subject
Phase: 3
Indication: Opioid Withdrawal
# of Subjects: 60
Inpatient Period: 7 days
Objectives
Primary
Investigate the efficacy, safety, and dose-response of XXXXX (2.4 mg or 3.2mg per day) in reducing withdrawal signs and symptoms and facilitating completion of detoxification/extending treatment retention in subjects undergoing detoxification
Secondary
Compare safety measures in the 2.4 mg and 3.2 mg total daily dose groups to assess whether the lower dose results in fewer and less severe adverse events than does the higher dose.
Assessments
Subjective Opiate Withdrawal Scale (SOWS) Clinical Opiate Withdrawal Scale (COWS)Modified Clinical Global Impressions Scale (MCGI) Mini International Neuropsychiatric Interview (M.I.N.I.)Columbia-Suicide Severity Rating Scale (C-SSRS)Objective Opiate Withdrawal Scale (OOWS-Handelsman) Visual Analog Scale for Efficacy (VAS-E)
Pharmacokinetic Sampling - 32 per subject
ECGs – 17 per subject Day -6 – 4 readings to be time-matched to the post randomization schedule Day 1 and 7 – 4 readings per day Day 2 and 4 – 1 reading per day Day 8 – 2 readings Day 14 – 1 reading
Vitals – 66 per subject
