Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study

Temple University

Status and phase: Completed; Phase 1

Conditions: Cocaine Dependence; Cocaine Addiction; Cocaine-Related Disorders; Cocaine Abuse

Treatments: Drug: Clavulanic acid; Drug: Placebo; Drug: Intravenous cocaine

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

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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: Placebo

Drug: Intravenous cocaine

Drug: Clavulanic acid

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: Placebo

Drug: Intravenous cocaine

Drug: Clavulanic acid

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: Placebo

Drug: Intravenous cocaine

Drug: Clavulanic acid