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New treatment option for Tobacco Use Disorder
Official title An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction
ClinicalTrials.gov ID: NCT03713424
What this study is testing
What is Clavulanic Acid?
Clavulanic Acid is an investigational medicine, being studied as a potential treatment for tobacco use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Entry criteria: all people:
- 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...
You likely can't join if
- all people:
- 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...
- Any physical or intellectual disability affecting completion of assessments
- Any contraindication to MRI
- Use of antidepressants medications with smoking cessation how well it works
See the full eligibility criteria
- Entry criteria: all people:
- 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
- all people:
- 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 how well it works
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbia, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbia, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.