Clavulanic Acid for the Treatment of Cocaine Use Disorder

Cocaine Dependence Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05562349
• Other study ID #: 30076
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 3, 2023
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Clavulanic Acid Only Product
Drug will be given in 250mg capsules
• Placebo
Capsule with no active medication - identical to drug capsule

Locations

Country	Name	City	State
United States	MUSC	Charleston	South Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Temple University	Medical University of South Carolina, Research Foundation for Mental Hygiene, Inc., University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in withdrawal symptoms over weeks 1, 2, 3 will occur in CLAV vs PBO group	Withdrawal symptoms will be measured using the Cocaine Selective Severity Assessment (CSSA)	Weekly for 3 weeks
Other	Executive control will change more in the CLAV group compared with the PBO group after 12 weeks	Delay discounting will measure executive control	Baseline, week 4, week 8, week 12
Other	Adverse Childhood Experiences (ACE) may correlate with cocaine relapse	Relationship between baseline scores from the ACE scale and abstinence outcomes in CLAV group will be compared to PBO group	Baseline, week 12, follow-up
Primary	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	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	Self reported cocaine use and Urine Drug Screen (UDS) will be administered 1-3 times per week and at follow-up
Secondary	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	TLFB and UDS will be administered 1-3 times per week and at follow-up
Secondary	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	Baseline, week 4, week 8, week 12
Secondary	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	1-3 times per week and at follow-up
Secondary	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	1-3 times per week and at follow-up