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Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study

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Temple University

Status and phase

Completed
Phase 1

Conditions

Cocaine Dependence
Cocaine Addiction
Cocaine-Related Disorders
Cocaine Abuse

Treatments

Drug: Intravenous cocaine
Drug: Placebo
Drug: Clavulanic acid

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02563769
1U54DA039002-01 (U.S. NIH Grant/Contract)
23222

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

10 participants in 3 patient groups

Clavulanic Acid (CLAV) 250mg; CLAV 500mg then Placebo (PBO)
Experimental group
Description:
Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Clavulanic Acid 500 mg; Day #4: Placebo
Treatment:
Drug: Clavulanic acid
Drug: Placebo
Drug: Intravenous cocaine
CLAV 250mg; PBO; then CLAV 500mg
Experimental group
Description:
Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Placebo; Day #4: Clavulanic Acid 500 mg
Treatment:
Drug: Clavulanic acid
Drug: Placebo
Drug: Intravenous cocaine
PBO; CLAV 250mg; then CLAV 500mg
Experimental group
Description:
Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Placebo; Day #3: Clavulanic Acid 250 mg (low dose); Day #4: Clavulanic Acid 500 mg
Treatment:
Drug: Clavulanic acid
Drug: Placebo
Drug: Intravenous cocaine

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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