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Clavulanic Acid for the Treatment of Cocaine Use Disorder

Temple University logo

Temple University

Status and phase

Active, not recruiting
Phase 2

Conditions

Cocaine Dependence

Treatments

Drug: Clavulanic Acid Only Product
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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)

Full 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.

Enrollment

65 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

65 participants in 2 patient groups, including a placebo group

Clavulanic Acid
Experimental group
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.
Treatment:
Drug: Clavulanic Acid Only Product
Placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Central trial contact

Yaminah Carter

Data sourced from clinicaltrials.gov

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