Adults 18 to 70, any sex, with Cocaine Dependence. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Brain Glutamate Concentration in the Anterior Cingulate Cortex (ACC) in Subjects With Cocaine Use Disorder (CUD) Treated With Escalating Doses of Clavulanate (CLAV)Primary· ACC glutamate and CCQ will be measured and correlated on Day 10 of treatment with CLAV compared with baseline.
Brain glutamate concentration in the ACC (based on Magnetic Resonance Spectroscopy (MRS)) will be correlated with cocaine craving (measured by Cocaine Craving Questionnaire (CCQ)) in subjects receiving escalating doses of CLAV for 10 days. Measurement will be made at baseline and Day 10 of CLAV (1000 mg/day) in subjects with cocaine use disorder.
Group
Value
95% CI
Clavulanic Acid Day 10
-0.9000
Clavulanic Acid Baseline
0.3333
Changes in Resting State Network Connectivity From BaselineSecondary· Assessment was done at the end of Period 1, 2 and 3 detailed above. Data from the end of Period 3 (Day 10, 1000mg CLAV) are reported.
Craving-associated neurocircuitry (frontal-striatal-thalamic connectivity) will be examined with resting state functional Magnetic Resonance Imaging (rs-fMRI) and Cocaine Craving Questionnaire (CCQ-45). The CCQ is comprised of five 9-item sub-scales (desire to use cocaine, intention and planning to use cocaine, anticipation of positive outcome from use, anticipation of relief from withdrawal or dysphoria, and lack of control over use) measured on a scale of 1 to 7, total scores ranging from 45 to 315 with higher numbers indicating increased craving.. The rs-fMRI activity and CCQ were assessed
Group
Value
95% CI
Rs-fMRI and CCQ on Day 10 CLAV
-0.8333
CravingSecondary· CCQ-45 questionnaires were completed daily during the study. Data from day 10 adjusted for baseline score are reported.
Craving will be evaluated by Cocaine Craving Questionnaire (CCQ-45). The CCQ is comprised of five 9-item sub-scales (desire to use cocaine, intention and planning to use cocaine, anticipation of positive outcome from use, anticipation of relief from withdrawal or dysphoria, and lack of control over use) measured on a scale of 1 to 7, total scores ranging from 45 to 315 with higher numbers indicating increased craving. The results are the CCQ scores on day 10 minus the baseline scores before starting study drug.
Group
Value
95% CI
Male CLAV Subjects--CCQ on Day 10
7
± 16
Male PBO Subjects--CCQ Score Day 10
-22
± 10
Female CLAV Subjects--CCQ Score Day 10
-15
± 21
Femaile PBO Subjects--CCQ Scores Day 10
49
± 0
Change in Brain Glutamine From BaselineSecondary· Brain glutamine will be analyzed at baseline (Day 1 prior to CLAV or PBO dose) and at Day 10 day (having completed Periods 1, 2 and 3 (CLAV 500mg/day for 3 days, 750 mg/day for 3 days and 1000 mg/day for 4 days).
Change in brain glutamine (Gln) concentration in the ACC at Day 10 compared to baseline as assessed by MRS in the ACC.
Group
Value
95% CI
Clavulanic Acid (CLAV) Group Baseline
1.5
± 1.0
Clavulanic Acid Day 10
2.1
± 2.0
Placebo Group Baseline
0.8
± 0.3
Placebo Group Day 10
0.7
± 0.6
Number of Participants With Treatment-related Adverse Events (AEs)Secondary· 1-24 days (during and up to 2 weeks after study dosing period)
Adverse events (AES) will be defined as any clinically significant changes in vital signs, clinically significant change in Electrocardiogram (EKG) from baseline measurement, clinically significant changes in laboratory bloodwork (Complete blood count, comprehensive metabolic panel, urinalysis), or any self reported side effects compared with baseline. AEs will be collected throughout the study and reviewed by a physician. An evaluation of AE severity (mild, moderate, severe) will be evaluated by a physician based on participant self-report. AEs per subject will be listed by organ system, and
Group
Value
95% CI
Clavulanic Acid
6
Placebo
1
Adverse events — posted to ClinicalTrials.gov
Time frame: 24 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Temple University
Last refreshed: 22 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04411914.