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Clavulanic Acid for Cocaine Use Disorder

Verified Trial
Phase 2
Recruiting
Led By Mary Morrison, MD, MS
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week 8, week 12
Awards & highlights

Study Summary

This trial tested a drug to treat cocaine addiction, finding it was both effective and safe.

Who is the study for?
Adults aged 18-70 with a diagnosis of moderate to severe cocaine use disorder in early remission, who understand the study and consent to participate. They must not have significant medical or psychiatric conditions that could interfere with the trial, no severe substance dependence other than cocaine or mild alcohol/marijuana, and no allergies to clavulanic acid or similar drugs.Check my eligibility
What is being tested?
The trial is testing Clavulanic Acid (CLAV) against a placebo (PBO) to see if it's effective and safe for treating people with cocaine use disorder. It's a dose escalation study where participants will receive increasing doses of CLAV or PBO.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions related to allergy history such as those associated with penicillin or beta-lactam drugs. Other common drug-related side effects might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a medical diagnosis of cocaine addiction and have been using the drug weekly or more often for at least one year, but are in the early stages of recovery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 8, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, week 8, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in relapse to cocaine use in CLAV group vs PBO group
Secondary outcome measures
Changes in subject health and function, quality-of-life, will be greater in the CLAV group vs. PBO group
Changes in weekly abstinence in the CLAV group vs. PBO group
Changes in weekly cocaine use will be greater in the CLAV group vs. PBO group
+2 more
Other outcome measures
Adverse Childhood Experiences (ACE) may correlate with cocaine relapse
Withdrawal Symptoms
Executive control will change more in the CLAV group compared with the PBO group after 12 weeks

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Clavulanic AcidExperimental Treatment1 Intervention
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 II: PlaceboPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Pennsylvania Perelman School of MedicineUNKNOWN
3 Previous Clinical Trials
1,791 Total Patients Enrolled
Medical University of South CarolinaOTHER
932 Previous Clinical Trials
7,394,195 Total Patients Enrolled
Research Foundation for Mental Hygiene, Inc.OTHER
66 Previous Clinical Trials
20,853 Total Patients Enrolled

Media Library

Clavulanic Acid (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05562349 — Phase 2
Cocaine Dependence Research Study Groups: Placebo, Clavulanic Acid
Cocaine Dependence Clinical Trial 2023: Clavulanic Acid Highlights & Side Effects. Trial Name: NCT05562349 — Phase 2
Clavulanic Acid (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05562349 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being included in this research?

"According to the eligibility requirements, individuals aged 18-70 are eligible for enrolment in this study."

Answered by AI

To what extent does the use of Clavulanic Acid pose a hazard for those involved in this treatment?

"Although there is some evidence of Clavulanic Acid's safey, the lack of clinical data on efficacy resulted in a score of 2."

Answered by AI

How many participants are eligible to join this clinical experiment?

"Yes, the clinicaltrials.gov website indicates that this trial is currently open for patient recruitment. It was first advertised on April 10th 2023 and has been updated recently as of April 11th 2023. There are 65 patients needed from two distinct locations."

Answered by AI

Is participation in this trial still possible at this juncture?

"Indeed, the clinical trial is open to new participants. First posted on April 10th 2023, it has been recently updated as of April 11th 2023 according to data hosted on clinicaltrials.gov"

Answered by AI

For which demographic does this clinical trial have the most relevance?

"This trial seeks to admit 65 individuals aged 18-70 who suffer from a DSM-V diagnosed cocaine use disorder in early remission. Participants must demonstrate the ability to comprehend and agree with the consent form, provide written informed consent, be willing to complete all study protocols, have no medical or psychiatric contraindications that would prohibit them from participation, and show a one year history of regular (weekly) consumption of snorted, smoked or injected cocaine."

Answered by AI

Who else is applying?

What site did they apply to?
Segal Trials - Lauderhill, FL
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

It appears I'm a good fit for this trial.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Clavulanic Acid for the Treatment of Cocaine Use Disorder
2023. "Clavulanic Acid for the Treatment of Cocaine Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05562349.
~34 spots leftby Apr 2025
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