Effects of clavulanic acid on smoking behavior in adults
An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction
This study tests if clavulanic acid can help adult smokers cut down on their cigarette use compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT03713424 on ClinicalTrials.gov |
What this trial studies
This research investigates how clavulanic acid influences smoking behavior among adult cigarette smokers. The study aims to determine if clavulanic acid can reduce smoking compared to a placebo over the course of the trial. Participants will be monitored for their smoking habits and assessed using functional MRI to evaluate brain activity related to addiction. The study includes adults aged 18-65 who smoke more than 10 cigarettes a day and have been smoking for at least two years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who smoke more than 10 cigarettes per day and have been smoking for at least two years.
Not a fit: Patients with a sensitivity to clavulanic acid or those with neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for individuals struggling with tobacco addiction.
How similar studies have performed: While the specific use of clavulanic acid for smoking cessation is novel, other studies have explored various pharmacological approaches to treat tobacco addiction with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbia, Missouri
- University of Missouri - Columbia — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Brett Froeliger, PhD — University of Missouri-Columbia
- Study coordinator: Madhura Athreya, MS
- Email: athreyam@health.missouri.edu
- Phone: 573-882-2977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.