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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clav | Active Comparator | 4-day 125 bid oral capsule administration |
|
| Placebo | Placebo Comparator | 4-day, twice-daily oral capsule administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clavulanic Acid | Drug | Beta lactamase inhibitor for smoking cessation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Magnitude of change in resting-stated fMRI brain connectivity |
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Entry criteria:
Inclusion Criteria all subjects:
Exclusion Criteria all subjects:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madhura Athreya, MS | Contact | 573-882-2977 | athreyam@health.missouri.edu | |
| Brett E Froeliger, PhD | Contact | 573-882-4785 | froeligerb@health.missouri.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brett Froeliger, PhD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri - Columbia | Recruiting | Columbia | Missouri | 65211 | United States |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| ID | Term |
|---|---|
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Placebo oral capsule |
| Drug |
placebo |
|
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 |
| Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |