NCT03713424

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
4mo left

Started Mar 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Mar 2019Aug 2026

First Submitted

Initial submission to the registry

October 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 26, 2019

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

October 28, 2025

Status Verified

October 1, 2025

Enrollment Period

7.4 years

First QC Date

October 17, 2018

Last Update Submit

October 24, 2025

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (2)

  • Cigarette Smoking

    Biochemical smoking assessment (breath carbon monoxide) at each study visit.

    5 days

  • Self Reported Side Effects

    Number of reported side effects

    5 Days

Secondary Outcomes (2)

  • Magnitude of change in BOLD fMRI brain response to smoking related images

    4 days

  • Magnitude of change in resting-stated fMRI brain connectivity

    4 days

Study Arms (2)

Clav

ACTIVE COMPARATOR

4-day 125 bid oral capsule administration

Drug: Clavulanic Acid

Placebo

PLACEBO COMPARATOR

4-day, twice-daily oral capsule administration

Drug: Placebo oral capsule

Interventions

Clavulanic AcidDRUG

Beta lactamase inhibitor for smoking cessation

Clav
Placebo oral capsuleDRUG

placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • English fluency
  • Functional vision (with corrective lenses as needed) to complete assigned assessments and tasks
  • 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)
  • If female, provide a negative urine pregnancy test.
  • 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

You may not qualify if:

  • Sensitivity or allergy to clavulanic acid/antibiotics
  • Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
  • Any physical or intellectual disability affecting completion of assessments
  • Any contraindication to MRI
  • Use of antidepressants medications with smoking cessation efficacy
  • Presence of an untreated illness or serious medical condition
  • Current or past psychosis
  • Electroconvulsive therapy in last 6 months
  • Positive pregnancy test (Urine pregnancy testing at screening and prior to fMRI scan) or currently breast feeding or BAC greater than 0.0
  • Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with CLAV) within 14 days of study participation
  • 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
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri - Columbia

Columbia, Missouri, 65211, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Clavulanic Acid

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Clavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Brett Froeliger, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madhura Athreya, MS

CONTACT

573-882-2977athreyam@health.missouri.edu

Brett E Froeliger, PhD

CONTACT

573-882-4785froeligerb@health.missouri.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 19, 2018

Study Start

March 26, 2019

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

October 28, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)