Trial · NCT02563769
Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study
NCT02563769, Phase 1, Completed, Temple University; results first posted 2023-11-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study. Trials, record NCT02563769. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02563769
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study
- NCT number
- NCT02563769
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Temple University
- Conditions
- Cocaine Dependence, Cocaine Addiction, Cocaine Abuse, Cocaine-Related Disorders
- Interventions
- Clavulanic acid, Intravenous cocaine, Placebo
- First posted
- 2015-09-30
- Last updated
- 2023-11-03
- Results first posted
- 2023-11-03
- Limitations and caveats
- The sample size was relatively small (n=10) and the current study was not powered to adequately explore efficacy.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Severe Adverse Events (AEs) | 6 Days (Study Days 1, 2, 3, 4, 5, 10) | Rates of occurrence of serious adverse events across the different treatments: Day 1-IV cocaine only; Day 2.3 and 4 treatment with either PBO, CLAV 250mg or CLAV 500mg depending on randomization; Day 5 CLAV 750mg, Day 10 Follow-up appointment See Adverse Event section for reporting of mild-moderate AEs. |
| Primary | Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing | 4 Days (Study Days 2, 3, 4, 5) | IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min preinfusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean heart rate (HR) at 2 minutes post IV cocaine infusion and the maximum (max) change in heart rate from baseline pre-infusion are reported (peak heart rate post-infusion minus baseline heart rate pre-infusion) are reported. |
| Primary | Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing | 4 Days (Study Days 2, 3, 4, 5) | IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min pre-infusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 2 minutes post IV cocaine infusion are reported. Also, the maximum (max) change in SBP snd DBP from baseline pre-infusion are reported (peak SBP or DBP post-infusion minus baseline SBP or DBP pre-infusion) are reported. |
| Primary | Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing | 4 Days (Study Days 2, 3, 4, 5) | ECG was done 15 min after IV cocaine infusion (following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg). The interval between the Q wave and the T wave, corrected (QTc) is reported. |
| Secondary | Pharmacokinetic (PK) Parameter of Cocaine-concentration | 3 Days (Study Days 2, 3, 4) | Cocaine concentrations are reported at 10 min and 30 minutes after cocaine infusion (70 and 90 minutes after administration of placebo (PBO), CLAV 250mg or CLAV 500mg). |
| Secondary | Clavulanic Acid (CLAV) Concentrations Following CLAV 250mg and CLAV 500mg Doses | 3 Days (Study Days 2, 3, 4) | CLAV concentrations were measured 40 min and 70 min after ingestion of CLAV 250 mg or 500 mg. (The 70 min time point is 10 min after the IV cocaine infusion).The 250mg dose and the 500mg dose were given on different days per the randomization protocol: the 250mg dose was given on either day 2 or 3 and the 500mg dose was given on either day 3 or 4. The lowest level of detection of CLAV is 40ng/ml. A non-detectable level is reported as 0. |
| Secondary | Difference in CLAV Concentrations Between the 250mg and 500mg CLAV Doses | 3 days (Day 2, 3, 4) | The CLAV concentration after ingestion of 250mg CLAV minus the CLAV PK level after the 500 mg dose is reported at 40min and 70 min after ingestion |
| Secondary | Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid | 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion on Study Days 2, 3, and 4 | Pupil Diameter (mm) was measured 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion. Cocaine infusion was done 1 hour following ingestion of placebo (day 2), CLAV 250 mg (day3), or CLAV 500 mg (day 4). Results are reported as median pupil diameter (mm) with interquartile range at different time points relative to the cocaine infusion as noted. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Severe Adverse Events (AEs) | 6 Days (Study Days 1, 2, 3, 4, 5, 10) | Participants were adults (18-65) with current cocaine use disorder who were recruited from the greater Philadelphia area. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing | 4 Days (Study Days 2, 3, 4, 5) | 10 participants were randomized to receive PBO or CLAV 250mg or 500mg on days 2,3 and 4 followed one hour later by IV infusion of cocaine. Part way through the study, a 5th day was added giving CLAV 750mg 1hr before the cocaine infusion (Protocol V2.3). Five participants were eligible for Day 5 but one had technical issues with the cocaine infusion and did not receive the full cocaine dose, so that subject is excluded from the report of day 5 effects. | beats per minute | MEAN |
| PRIMARY | Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing | 4 Days (Study Days 2, 3, 4, 5) | 10 participants were randomized to receive PBO or CLAV 250mg or 500mg on days 2,3 and 4 followed one hour later by IV infusion of cocaine. Part way through the study, a 5th day was added giving CLAV 750mg 1hr before the cocaine infusion (Protocol V2.3). Five participants were eligible for Day 5 but one had technical issues with the cocaine infusion and did not receive the full cocaine dose, so that subject is excluded from the report of day 5 effects. | mm Hg | MEAN |
| PRIMARY | Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing | 4 Days (Study Days 2, 3, 4, 5) | 10 participants were randomized to receive PBO or CLAV 250mg or 500mg on days 2,3 and 4 followed one hour later by IV infusion of cocaine. Part way through the study, a 5th day was added giving CLAV 750mg 1hr before the cocaine infusion (Protocol V2.3). Five participants were eligible for Day 5 but one had technical issues with the cocaine infusion and did not receive the full cocaine dose, so that subject is excluded from the report of day 5 effects. | ms | MEAN |
| SECONDARY | Pharmacokinetic (PK) Parameter of Cocaine-concentration | 3 Days (Study Days 2, 3, 4) | All 10 participants received PBO, CLAV 250mg or 500mg over 3 days in different order according to randomization. One participant is not included in the analysis due to inadequate samples obtained. | mg/L | MEAN |
| SECONDARY | Clavulanic Acid (CLAV) Concentrations Following CLAV 250mg and CLAV 500mg Doses | 3 Days (Study Days 2, 3, 4) | 10 subjects received 250mg and 500mg (randomized to different days) but samples for one subject was unusable. A second subject vomited 5 min after both the 250mg dose and the 500mg dose and levels were undetectable; this subject was excluded from analysis. This reports results of 8 subjects. | mg/L | MEDIAN |
| SECONDARY | Difference in CLAV Concentrations Between the 250mg and 500mg CLAV Doses | 3 days (Day 2, 3, 4) | 10 subjects were randomized and received 250mg and 500mg on different days based on their randomization. One subject's samples were unusable. A second subject vomited after each dose (250mg and 500mg), had nondetectable levels and was excluded in the calculation. This analysis is based on 8 subjects. | mg/L | MEDIAN |
| SECONDARY | Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid | 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion on Study Days 2, 3, and 4 | 10 subjects receiving IV cocaine infusion were randomized to receive either PBO, CLAV 250mg or CLAV 500mg on days 2, 3,and 4 depending on randomization | mm | MEDIAN |
Source ClinicalTrials.gov
Results by group61
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Severe Adverse Events (AEs) | Day 1 - IV Cocaine Only | 0 | Participants | ||
| Number of Participants With Severe Adverse Events (AEs) | Placebo (PBO) | 0 | Participants | ||
| Number of Participants With Severe Adverse Events (AEs) | CLAV 250mg | 0 | Participants | ||
| Number of Participants With Severe Adverse Events (AEs) | CLAV 500mg | 0 | Participants | ||
| Number of Participants With Severe Adverse Events (AEs) | Day 5--CLAV 750mg | 0 | Participants | ||
| Number of Participants With Severe Adverse Events (AEs) | Day 10--Follow up | 0 | Participants | ||
| Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing | Placebo (PBO) | HR at 2 min | 82.2 | Standard Deviation 14.7 | beats per minute |
| Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing | CLAV 250mg | HR at 2 min | 78.0 | Standard Deviation 5.7 | beats per minute |
| Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing | CLAV 500mg | HR at 2 min | 86.8 | Standard Deviation 13.0 | beats per minute |
| Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing | Day 5--CLAV 750mg | HR at 2 min | 91.0 | Standard Deviation 14.7 | beats per minute |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| IV Cocaine Only (Day 1) | STARTED | Placebo; Clav 250mg, Then Clav 500mg | 3 | |
| IV Cocaine Only (Day 1) | STARTED | Clav 250mg; Placebo; Then Clav 500mg | 3 | |
| IV Cocaine Only (Day 1) | STARTED | Clav 250mg; Clav 500mg; Then Placebo | 4 | |
| IV Cocaine Only (Day 1) | COMPLETED | Placebo; Clav 250mg, Then Clav 500mg | 3 | |
| IV Cocaine Only (Day 1) | COMPLETED | Clav 250mg; Placebo; Then Clav 500mg | 3 | |
| IV Cocaine Only (Day 1) | COMPLETED | Clav 250mg; Clav 500mg; Then Placebo | 4 | |
| IV Cocaine Only (Day 1) | NOT COMPLETED | Placebo; Clav 250mg, Then Clav 500mg | 0 | |
| IV Cocaine Only (Day 1) | NOT COMPLETED | Clav 250mg; Placebo; Then Clav 500mg | 0 | |
| IV Cocaine Only (Day 1) | NOT COMPLETED | Clav 250mg; Clav 500mg; Then Placebo | 0 | |
| FIrst Treatment (Day 2) | STARTED | Placebo; Clav 250mg, Then Clav 500mg | 3 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events126
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | upper respiratory infection (URI) | Infections and infestations | Day 1-IV Cocaine Infusion Only | 0 | 10 | |
| other | upper respiratory infection (URI) | Infections and infestations | Placebo + IV Cocaine | 0 | 10 | |
| other | upper respiratory infection (URI) | Infections and infestations | CLAV 250mg + IV Cocaine | 0 | 10 | |
| other | upper respiratory infection (URI) | Infections and infestations | CLAV 500mg + IV Cocaine | 0 | 10 | |
| other | upper respiratory infection (URI) | Infections and infestations | Day 5--CLAV 750mg + IV Cocaine | 0 | 5 | |
| other | upper respiratory infection (URI) | Infections and infestations | Discharge Day | 0 | 10 | |
| other | upper respiratory infection (URI) | Infections and infestations | Day 10-Follow-up | 2 | 10 | 2 |
| other | Ventricular tachycardia | Cardiac disorders | Day 1-IV Cocaine Infusion Only | 1 | 10 | 1 |
| other | Ventricular tachycardia | Cardiac disorders | Placebo + IV Cocaine | 0 | 10 | 0 |
| other | Ventricular tachycardia | Cardiac disorders | CLAV 250mg + IV Cocaine | 0 | 10 | 0 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Day 1-IV Cocaine Infusion Only | 0 | 10 |
| Total, all-cause mortality | Placebo + IV Cocaine | 0 | 10 |
| Total, all-cause mortality | CLAV 250mg + IV Cocaine | 0 | 10 |
| Total, all-cause mortality | CLAV 500mg + IV Cocaine | 0 | 10 |
| Total, all-cause mortality | Day 5--CLAV 750mg + IV Cocaine | 0 | 5 |
| Total, all-cause mortality | Discharge Day | 0 | 10 |
| Total, all-cause mortality | Day 10-Follow-up | 0 | 10 |
| Total, other adverse events | Day 1-IV Cocaine Infusion Only | 5 | 10 |
| Total, other adverse events | Placebo + IV Cocaine | 4 | 10 |
| Total, other adverse events | CLAV 250mg + IV Cocaine | 3 | 10 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U54DA039002 | Center for the Development of Novel Medications for Cocaine Dependence | KAMPMAN, KYLE MATTHEW | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE ON DRUG ABUSE | 2014 to 2018 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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