Status:
COMPLETED
Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid
Lead Sponsor:
Temple University
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
University of Pennsylvania
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
A dose-escalation study to determine the optimum dose of Clavulanic Acid (CLAV) for effects on craving and efficacy.
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel group inpatient study of clavulanic acid for 10 days in adults (18-65) seeking treatment for cocaine use disorder. For those subjects w...
Eligibility Criteria
Inclusion
- Be able to verbalize understanding of consent form
- Be male or female adult volunteers ages 18-65 inclusive.
- Have a Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of cocaine use disorder, moderate to severe in early remission
- Have a Body Mass Index (BMI) of 17.5 to 39.9 kg/m2; and a total body weight of at least 45 kg (99 lbs.)
- Have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, and/ or significant or unstable medical or psychiatric illness.
Exclusion
- Have a current DSM-5 substance use disorder, mild, moderate, or severe, on any drug of abuse other than nicotine, caffeine, and cocaine use disorder in early remission verified by Urine Drug Screen (UDS). Alcohol use disorder and marijuana use disorder, mild without withdrawal symptoms, will be permitted.
- Have any previous medically adverse reaction to CLAV, Augmentin, penicillin, Ticarcillin, cephalosporin, or any beta-lactam drug.
- Have any illness, condition, and use of medications, in the opinion of the principal investigator, sub-investigators which would preclude safe and/or successful completion of the study.
- Report having human immunodeficiency virus (HIV) infection or test positive for HIV during screening
- Be pregnant (females).
- Unable to tolerate MRI scan for duration of 60 minutes for physical or psychological reasons.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04411914
Start Date
September 1 2020
End Date
March 31 2022
Last Update
June 22 2023
Active Locations (1)
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1
Temple University Episcopal Hospital
Philadelphia, Pennsylvania, United States, 19125