Clavulanic Acid for the Treatment of Cocaine Use Disorder

NCT ID: NCT05562349

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-03
• Study Completion Date: 2024-07-31

Brief Summary

A dose escalation study to assess the efficacy and safety of Clavulanic Acid (CLAV) vs. placebo (PBO) for the treatment of cocaine use disorder (CUD)

Detailed Description

This pilot study is indicated for treatment of moderate to severe cocaine use disorder. It is a randomized, placebo-controlled, parallel group, multi-center pilot study to compare the efficacy of 500-750mg/day clavulanic acid vs. placebo in addition to weekly medication management therapy. Subjective, cognitive, and adverse effect assessments, blood pressure and pulse will be performed 1-3 times weekly.

Conditions

Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Clavulanic Acid

Participants may receive 500 mg of CLAV at baseline. Subjects who are using cocaine once per week or more and who can tolerate 500 mg/day for 4 weeks, will have a dose escalation to 750 mg/day. If tolerated, 750mg/day will be maintained for 8 weeks, otherwise the dose will decrease to 500mg/day.

Group Type: EXPERIMENTAL

Clavulanic Acid Only Product

Intervention Type: DRUG

Drug will be given in 250mg capsules

Placebo

Participants may receive placebo and serve as a control group. They will be blinded to their condition and will have a "dose" escalation at the same time as the experimental group, and be given additional placebo pills to match the number given to the experimental group.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Capsule with no active medication - identical to drug capsule

Interventions

Clavulanic Acid Only Product

Drug will be given in 250mg capsules

Intervention Type: DRUG

Placebo

Capsule with no active medication - identical to drug capsule

Intervention Type: DRUG

Other Intervention Names

Potassium clavulanate; microcrystalline cellulose

Eligibility Criteria

Inclusion Criteria

• Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
• Be male or female adult volunteers ages 18-70 inclusive.
• Have a Diagnostic and Statistical Manual (DSM-V) diagnosis of cocaine use disorder, moderate to severe in early remission with a duration of regular (weekly or more) cocaine (either snorted, smoked or injected) for at least one year.
• Have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, and/ or significant or unstable medical or psychiatric illness.

Exclusion Criteria

• Meets DSM-V criteria for dependence on any substance other than cocaine and mild to moderate alcohol or marijuana (except nicotine or caffeine), determined by the structured clinical interview for DSM-V.
• Allergy to clavulanic acid, penicillin, or any beta-lactam drug.
• Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder. Subject meets current DSM-V diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation.
• Severe physical or medical illnesses such as AIDS or active hepatitis.
• If female, tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Morrison, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

MUSC

Charleston, South Carolina, United States

Countries

United States

References

Kim J, John J, Langford D, Walker E, Ward S, Rawls SM. Clavulanic acid enhances glutamate transporter subtype I (GLT-1) expression and decreases reinforcing efficacy of cocaine in mice. Amino Acids. 2016 Mar;48(3):689-696. doi: 10.1007/s00726-015-2117-8. Epub 2015 Nov 5.

Reference Type: RESULT

PMID: 26543027 (View on PubMed)

Other Identifiers

30076

Identifier Type: -

Identifier Source: org_study_id