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

Primary Purpose

Tobacco Use Disorder

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Clavulanic Acid

Placebo oral capsule

About this trial

This is an interventional basic science trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Entry criteria:

Inclusion Criteria all subjects:

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

Exclusion Criteria all subjects:

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

Sites / Locations

University of Missouri - ColumbiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Clav

Placebo

Arm Description

4-day 125 bid oral capsule administration

4-day, twice-daily oral capsule administration

Outcomes

Primary Outcome Measures

Cigarette Smoking

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

Magnitude of change in fMRI brain response to 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

Magnitude of change in 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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03713424

First Posted

October 17, 2018

Last Updated

May 31, 2023

Sponsor

University of Missouri-Columbia

1. Study Identification

Unique Protocol Identification Number

NCT03713424

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 26, 2019 (Actual)

Primary Completion Date

August 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Use Disorder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clav

Arm Type

Active Comparator

Arm Description

4-day 125 bid oral capsule administration

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

4-day, twice-daily oral capsule administration

Intervention Type

Drug

Intervention Name(s)

Clavulanic Acid

Intervention Description

Beta lactamase inhibitor for smoking cessation

Intervention Type

Drug

Intervention Name(s)

Placebo oral capsule

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Cigarette Smoking

Description

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

Time Frame

5 days

Title

Magnitude of change in fMRI brain response to images

Description

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

Time Frame

4 days

Title

Magnitude of change in fMRI brain connectivity

Description

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.

Time Frame

4 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Entry criteria: Inclusion Criteria all subjects: 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 Exclusion Criteria all subjects: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Madhura Athreya, MS

Phone

573-882-2977

athreyam@health.missouri.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Brett E Froeliger, PhD

Phone

573-882-4785

froeligerb@health.missouri.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brett Froeliger, PhD

Organizational Affiliation

University of Missouri-Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Missouri - Columbia

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65211

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brett Froeliger, PhD

Phone

513-882-4785

froeligerb@health.missouri.edu

First Name & Middle Initial & Last Name & Degree

Madhura Athreya, MS

Phone

573-882-2977

athreyam@health.missouri.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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