An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · Oct 17, 2018

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called clavulanic acid may help adult smokers reduce their smoking behavior. Researchers want to see if taking clavulanic acid can help people smoke less compared to those who do not receive the medication (they would receive a placebo, which is a harmless sugar pill). The study is looking for adults aged 18 to 65 who smoke more than 10 cigarettes a day and have been smoking for at least two years. Participants must also be able to communicate in English and have good vision, with corrective lenses if needed.

If you join the study, you will need to stop using all other tobacco and nicotine products during the trial. Before participating, you will go through some screenings to make sure you are healthy enough for the study. During the trial, you can expect to complete various assessments, including brain scans using MRI technology, to help researchers understand how clavulanic acid might affect smoking habits. It's important to know that there are certain health conditions and medications that may exclude someone from participating, so the research team will assess your eligibility carefully.

Gender

ALL

Eligibility criteria

• Entry criteria:
• Inclusion Criteria all subjects:
• • 1. Age 18-65 years
• • 2. English fluency
• • 3. Functional vision (with corrective lenses as needed) to complete assigned assessments and tasks
• • 4. Smoke \> 10 cigarettes/day for a minimum of 2 yrs. and have an expired carbon monoxide (CO) concentration of ≥ 10 ppm (to confirm inhalation at screening and scanning)
• • 5. If female, provide a negative urine pregnancy test.
• • 6. Agrees to refrain from all other tobacco (i.e., dip/chew, cigars, cigarillos) and/or nicotine products (i.e., e-cigs, patches, gum/lozenges, inhalers/sprays) for the duration of study participation
• Exclusion Criteria all subjects:
• • 1. Sensitivity or allergy to clavulanic acid/antibiotics
• • 2. Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
• • 3. Any physical or intellectual disability affecting completion of assessments
• • 4. Any contraindication to MRI
• • 5. Use of antidepressants medications with smoking cessation efficacy
• • 6. Presence of an untreated illness or serious medical condition
• • 7. Current or past psychosis
• • 8. Electroconvulsive therapy in last 6 months
• • 9. Positive pregnancy test (Urine pregnancy testing at screening and prior to fMRI scan) or currently breast feeding or BAC greater than 0.0
• • 10. Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with CLAV) within 14 days of study participation
• • 11. Abnormal liver function determined by Complete Metabolic Panel - liver enzymes outside normal ranges of AST (SGOT) 5-40 unites/L and ALT( SGPT) 7-56units/L
• • 12. Abnormal renal function determined by Complete Metabolic Panel - outside normal ranges of BUN 6-24 mg /dl and Creatinine level 0.6 -1.2 mg /dl male, 0.5-1.1mg /dl female
• • 13. Any other condition or concern that in the investigator's opinion would impact participant safety, compliance with study instructions, or potentially confound the interpretation of the study results