Cocaine Dependence
Conditions
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.
Interventions
DRUGClavulanic Acid Only Product
Drug will be given in 250mg capsules
DRUGPlacebo
Capsule with no active medication - identical to drug capsule
Sponsors
University of Pennsylvania
Medical University of South Carolina
Research Foundation for Mental Hygiene, Inc.
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blind, placebo-controlled, parallel group study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in relapse to cocaine use in CLAV group vs PBO group | Last 3 weeks of 12 week study | Cocaine-free weeks are measured by self-report using Timeline Follow Back (TLFB) and confirmed by urine drug screen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in weekly cocaine use will be greater in the CLAV group vs. PBO group | TLFB and UDS will be administered 1-3 times per week and at follow-up | 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 | Baseline, week 4, week 8, week 12 | 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 | 1-3 times per week and at follow-up | 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 | 1-3 times per week and at follow-up | 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 |
| Changes in weekly abstinence in the CLAV group vs. PBO group | Self reported cocaine use and Urine Drug Screen (UDS) will be administered 1-3 times per week and at follow-up | Abstinence from cocaine by week will be measured by self report and urine drug screen |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Childhood Experiences (ACE) may correlate with cocaine relapse | Baseline, week 12, follow-up | Relationship between baseline scores from the ACE scale and abstinence outcomes in CLAV group will be compared to PBO group |
| Changes in withdrawal symptoms over weeks 1, 2, 3 will occur in CLAV vs PBO group | Weekly for 3 weeks | Withdrawal symptoms will be measured using the Cocaine Selective Severity Assessment (CSSA) |
| Executive control will change more in the CLAV group compared with the PBO group after 12 weeks | Baseline, week 4, week 8, week 12 | Delay discounting will measure executive control |
Countries
United States
Outcome results
None listed