Phase 1
Completed N=13
Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid
Cocaine Dependence
Source: ClinicalTrials.gov NCT04411914 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Brain Glutamate Concentration in the Anterior Cingulate Cortex (ACC) in Subjects With Cocaine Use Disorder (CUD) Treated With Escalating Doses of Clavulanate (CLAV) — -0.9000; 0.3333 Spearman Correlation Coefficient — p=0.0009
Summary
A dose-escalation study to determine the optimum dose of Clavulanic Acid (CLAV) for effects on craving and efficacy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Glutamate Concentration in the Anterior Cingulate Cortex (ACC) in Subjects With Cocaine Use Disorder (CUD) Treated With Escalating Doses of Clavulanate (CLAV) |
-0.9000; 0.3333 | 0.0009 sig |
| SECONDARY Changes in Resting State Network Connectivity From Baseline |
-0.8333 | 0.0053 sig |
| SECONDARY Craving |
7; -22; -15; 49 | — |
| SECONDARY Change in Brain Glutamine From Baseline |
1.5; 2.1; 0.8; 0.7 | — |
| SECONDARY Number of Participants With Treatment-related Adverse Events (AEs) |
6; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04411914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.