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

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03713424
• Other study ID #: 2022247
• Status: Recruiting
• Phase: Phase 2
• Start date: March 26, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Missouri-Columbia
• Contact: Madhura Athreya, MS
• Phone: 573-882-2977
• Email: athreyam[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is looking into the effects of clavulanic on smoking behavior in adult cigarette smokers. The primary study hypothesis is that, compared to placebo, clavulanic acid will reduce smoking over the course of the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance-Related Disorders
• Tobacco Use Disorder

Intervention

Drug:
• Clavulanic Acid
Beta lactamase inhibitor for smoking cessation
• Placebo oral capsule
placebo

Locations

Country	Name	City	State
United States	University of Missouri - Columbia	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarette Smoking	Biochemical smoking assessment (breath carbon monoxide) at each study visit.	5 days
Primary	Self Reported Side Effects	Number of reported side effects	5 Days
Secondary	Magnitude of change in BOLD fMRI brain response to smoking related images	Measure the effects of Clavulanic Acid on fMRI BOLD response to images (change from baseline to end of study) while participants undergo functional magnetic resonance imaging	4 days
Secondary	Magnitude of change in resting-stated fMRI brain connectivity	Measure the effects of Clavulanic Acid on resting-state functional connectivity (change from baseline to end of study) while participants undergo functional magnetic resonance imaging.	4 days