Phase 1
Completed N=10
Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study
Cocaine Dependence · Cocaine Addiction · Cocaine Abuse · Cocaine-Related Disorders
Source: ClinicalTrials.gov NCT02563769 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Number of Participants With Severe Adverse Events (AEs) — 0; 0; 0; 0 Participants
Summary
The main purpose of this study is to determine if it is safe to use the study drug, clavulanic acid, in combination with cocaine. In this study, subjects will receive intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic acid is being studied so future studies can be done to find out if this drug is helpful in treating cocaine dependence. Currently, there is no available medication treatment for cocaine dependence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Severe Adverse Events (AEs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing |
82.2; 78.0; 86.8; 91.0; 26.3; 29.8 | — |
| PRIMARY Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing |
138.8; 135.0; 140.0; 137.8; 21.6; 23.5 | — |
| PRIMARY Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing |
431.8; 432.3; 430.5; 431.3 | — |
| SECONDARY Pharmacokinetic (PK) Parameter of Cocaine-concentration |
0.355; 0.240; 0.372; 0.215; 0.344; 0.209 | — |
| SECONDARY Clavulanic Acid (CLAV) Concentrations Following CLAV 250mg and CLAV 500mg Doses |
0.036; 0.506; 0.394; 1.912 | — |
| SECONDARY Difference in CLAV Concentrations Between the 250mg and 500mg CLAV Doses |
0.227; 0.331 | 0.69 |
| SECONDARY Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid |
3.1; 3.10; 3.20; 3.55; 3.70; 3.90 | — |
Eligibility Criteria
Inclusion Criteria
- Meet Diagnostic and Statistical Manual of Mental Disorders Fifth Edition criteria for cocaine use disorder, moderate to severe.
- Be a non-treatment seeking cocaine user.
- If female and of childbearing potential, must have a negative pregnancy test within 48 hours of beginning the study and be willing to use acceptable contraception or be abstinent for 14 days prior to study, through the entire study and 30 days after study participation.
Exclusion Criteria
- Be seeking treatment for substance abuse.
(For full inclusion/exclusion criteria or for more information, please contact the site directly.)
Data sourced from ClinicalTrials.gov (NCT02563769). 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.