Clavulanic Acid for the Treatment of Cocaine Use Disorder

NCT05562349 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 30076
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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)

Conditions

Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• Changes in relapse to cocaine use in CLAV group vs PBO group

  Cocaine-free weeks are measured by self-report using Timeline Follow Back (TLFB) and confirmed by urine drug screen.

  Last 3 weeks of 12 week study

Secondary Outcomes (5)

• Changes in weekly abstinence in the CLAV group vs. PBO group

  Self reported cocaine use and Urine Drug Screen (UDS) will be administered 1-3 times per week and at follow-up

• Changes in weekly cocaine use will be greater in the CLAV group vs. PBO group

  TLFB and UDS will be administered 1-3 times per week and at follow-up

• Changes in subject health and function, quality-of-life, will be greater in the CLAV group vs. PBO group

  Baseline, week 4, week 8, week 12

• Clavulanic acid 500-750 mg/day for 12 weeks will be safe and reasonably well tolerated

  1-3 times per week and at follow-up

• Cocaine craving will be decreased more by CLAV vs. PBO

  1-3 times per week and at follow-up

Other Outcomes (3)

• Changes in withdrawal symptoms over weeks 1, 2, 3 will occur in CLAV vs PBO group

  Weekly for 3 weeks

• Executive control will change more in the CLAV group compared with the PBO group after 12 weeks

  Baseline, week 4, week 8, week 12

• Adverse Childhood Experiences (ACE) may correlate with cocaine relapse

  Baseline, week 12, follow-up

Study Arms (2)

Clavulanic Acid

EXPERIMENTAL

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.

Drug: Clavulanic Acid Only Product

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Clavulanic Acid Only Product DRUG

Drug will be given in 250mg capsules

Also known as: Potassium clavulanate

Clavulanic Acid

Placebo DRUG

Capsule with no active medication - identical to drug capsule

Also known as: microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Temple University: lead
• University of Pennsylvania: collaborator
• Medical University of South Carolina: collaborator
• Research Foundation for Mental Hygiene, Inc.: collaborator

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MUSC

Charleston, South Carolina, 29403, United States

Location

Related Publications (1)

• 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.

  PMID: 26543027 RESULT

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Clavulanic Acid; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mary Morrison, MD, MS

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel group study

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 30, 2022
• Study Start: May 3, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)