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)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
Drug will be given in 250mg capsules
Capsule with no active medication - identical to drug capsule
University of Pennsylvania
Philadelphia, Pennsylvania, United States
MUSC
Charleston, South Carolina, United States
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.
Time frame: Last 3 weeks of 12 week study
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
Time frame: 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
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
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
Time frame: Baseline, week 4, week 8, week 12
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
Time frame: 1-3 times per week and at follow-up
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
Time frame: 1-3 times per week and at follow-up
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