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The Effects of Clavulanic Acid on Tobacco Use Disorder (CLAV)

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ClinicalTrials.gov Identifier: NCT03713424
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Brett Froeliger, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Clavulanic Acid Drug: Placebo oral capsule Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: An fMRI Pilot Study of the Effects of Clavulanic Acid on Cigarette Withdrawal
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Active Comparator: Clav
4-day 125 bid oral capsule administration
Drug: Clavulanic Acid
Beta lactamase inhibitor for smoking cessation

Placebo Comparator: Placebo
4-day, twice-daily oral capsule administration
Drug: Placebo oral capsule
placebo




Primary Outcome Measures :
  1. Cigarette Smoking [ Time Frame: 5 days ]
    Biochemical smoking assessment (breath carbon monoxide) at each study visit.

  2. Magnitude of change in fMRI brain response to images [ Time Frame: 4 days ]
    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

  3. Magnitude of change in fMRI brain connectivity [ Time Frame: 4 days ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Entry criteria:

Inclusion Criteria all subjects:

  1. Age 18-65 years
  2. Right Handed
  3. English fluency
  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);

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. Any use of psychotropic substances through positive drug screen (such as marijuana or cocaine) or abuse of prescription medications (such as benzodiazepines or opiates) within the last month. Diagnosis of substance use disorder (SUD; other than nicotine)
  6. Presence of an untreated illness
  7. Current or past psychosis
  8. Positive pregnancy test (Urine pregnancy testing at screening and prior to fMRI scan).
  9. Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713424


Contacts
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Contact: Madhura Athreya, MS 843-792-1608 athreya@Musc.edu
Contact: Brett E Froeliger, PhD 843-7926018 froelige@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Brett Froeliger, PhD    843-792-6018    athreya@musc.edu   
Contact: Madhura Athreya, MS    8437921608    athreya@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Brett Froeliger, PhD Medical University of South Carolina

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Responsible Party: Brett Froeliger, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03713424     History of Changes
Other Study ID Numbers: 00078213
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Clavulanic Acids
Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors