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Completed

NCT Number: NCT02563769

Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study

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.

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Key information

Conditions

Cocaine Dependence Chemically-Induced Disorders Cocaine Abuse Cocaine Addiction Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Temple University Hospital - Episcopal Campus

Philadelphia, Pennsylvania, 19125, United States

About this study

This is a prospective, placebo controlled inpatient crossover safety study of 3 doses (250 mg/day, 500 mg/day, 750 mg/day) of CLAV with an intravenous infusion of cocaine 40 mg. Subjects will be non-treatment seeking experienced cocaine dependent adults, ages 18-65 (N=12 completers, 21 estimated to enroll). Subjects will undergo a washout of the study drug for 5 half-lives between study drug administration sessions.

The primary objective will be to determine whether there are clinically significant adverse interactions between CLAV (250 mg/day; 500 mg/day; 750 mg/day) and intravenously administered cocaine in healthy, non-treatment seeking adults with cocaine use disorder.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Clavulanic Acid

Drug

Clavulanic acid will be administered orally in 250mg capsules

Other names: CLAV

Intravenous cocaine

Drug

20/40mg Cocaine will be administered by IV

Other names: Coc

Placebo

Drug

Placebo will be administered orally in capsules identical to CLAV and be filled with crystalline microcellulose

Other names: PBO

Primary outcomes

  1. Number of Participants With Severe Adverse Events (AEs)

    Time frame: 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.

  2. Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing

    Time frame: 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.

  3. Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing

    Time frame: 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.

  4. Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing

    Time frame: 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 outcomes

  1. Pharmacokinetic (PK) Parameter of Cocaine-concentration

    Time frame: 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).

  2. Clavulanic Acid (CLAV) Concentrations Following CLAV 250mg and CLAV 500mg Doses

    Time frame: 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.

  3. Difference in CLAV Concentrations Between the 250mg and 500mg CLAV Doses

    Time frame: 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

  4. Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Pennsylvania

Registry information

Official study title

Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Clavulanic Acid

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 30, 2015
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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