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Clavulanic Acid for the Treatment of Cocaine Use Disorder

Primary Purpose

Cocaine Dependence

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Clavulanic Acid Only Product

Placebo

About this trial

This is an interventional treatment trial for Cocaine Dependence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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)

Sites / Locations

University of PennsylvaniaRecruiting
MUSCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clavulanic Acid

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Abstinence from cocaine by week will be measured by self report and urine drug screen

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

Cocaine-free visits are measured by self-report using TLFB confirmed by urine drug screen

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

Medical Outcomes Study Quality of Life Scale short form 36, will determine whether CLAV treatment is associated with improved QOL

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

Safety and tolerability as assessed by the rates of occurrence of adverse events (AEs) and the severity

Cocaine craving will be decreased more by CLAV vs. PBO

Changes in craving will be greater in the CLAV group compared with PBO group, as measured by the cocaine craving questionnaire (CCQ), adjusted for baseline and sex

Full Information

NCT ID

NCT05562349

First Posted

September 15, 2022

Last Updated

May 3, 2023

Sponsor

Temple University

Collaborators

University of Pennsylvania, Medical University of South Carolina, Research Foundation for Mental Hygiene, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05562349

Brief Title

Clavulanic Acid for the Treatment of Cocaine Use Disorder

Official Title

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Pilot Study to Assess the Efficacy and Safety of Clavulanic Acid vs. Placebo for the Treatment of Cocaine Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 3, 2023 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Temple University

Collaborators

University of Pennsylvania, Medical University of South Carolina, Research Foundation for Mental Hygiene, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized, double-blind, placebo-controlled, parallel group study

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clavulanic Acid

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Clavulanic Acid Only Product

Intervention Description

Drug will be given in 250mg capsules

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

microcrystalline cellulose

Intervention Description

Capsule with no active medication - identical to drug capsule

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Last 3 weeks of 12 week study

Secondary Outcome Measure Information:

Title

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

Description

Abstinence from cocaine by week will be measured by self report and urine drug screen

Time Frame

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

Title

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

Description

Cocaine-free visits are measured by self-report using TLFB confirmed by urine drug screen

Time Frame

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

Title

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

Description

Medical Outcomes Study Quality of Life Scale short form 36, will determine whether CLAV treatment is associated with improved QOL

Time Frame

Baseline, week 4, week 8, week 12

Title

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

Description

Safety and tolerability as assessed by the rates of occurrence of adverse events (AEs) and the severity

Time Frame

1-3 times per week and at follow-up

Title

Cocaine craving will be decreased more by CLAV vs. PBO

Description

Changes in craving will be greater in the CLAV group compared with PBO group, as measured by the cocaine craving questionnaire (CCQ), adjusted for baseline and sex

Time Frame

1-3 times per week and at follow-up

Other Pre-specified Outcome Measures:

Title

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

Description

Withdrawal symptoms will be measured using the Cocaine Selective Severity Assessment (CSSA)

Time Frame

Weekly for 3 weeks

Title

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

Description

Delay discounting will measure executive control

Time Frame

Baseline, week 4, week 8, week 12

Title

Adverse Childhood Experiences (ACE) may correlate with cocaine relapse

Description

Relationship between baseline scores from the ACE scale and abstinence outcomes in CLAV group will be compared to PBO group

Time Frame

Baseline, week 12, follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yaminah Carter

Phone

2157078980

yaminah.carter@tuhs.temple.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Morrison, MD, MS

Organizational Affiliation

Temple University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matt Taylor

Phone

215-746-0467

matthew.taylor@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name & Degree

Kyle Kampman, MD

Facility Name

MUSC

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29403

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lisa Nunn

Phone

843-792-0476

jenkinli@musc.edu

First Name & Middle Initial & Last Name & Degree

Aimee McRae-Clark

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26543027

Citation

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.

Results Reference

result

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Clavulanic Acid for the Treatment of Cocaine Use Disorder

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