Nicotinic Agonist Effects on BMI and Neuronal Response

Study Overview
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Brief Summary
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Obesity is a serious and growing health problem in the United States. Obesity is associated with health problems such as type-2 diabetes and cardiovascular disease, leading to decreased quality of life and increased mortality. Given the health and quality-of-life effects of obesity, developing effective treatments clearly is an important goal. This study plans to learn more about the effects of an investigational new drug (DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine)) and its effects on obesity. The study drug has similar effects to nicotine. Since nicotine has been found to affect appetite, the investigators are interested in studying effects of the study drug, which has some similarities to nicotine, on how your brain responds to such things as pictures of food. The study drug has not been approved by the Food and Drug Administration (FDA), and is considered experimental.

Official Title
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Nicotinic Agonist Effects on BMI and Neuronal Response in Overweight/Obese Adults

Conditions
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Obesity

Intervention / Treatment
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* Drug: DMXB-A
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight/obese (BMI > 27) Between 21-65 years old Exclusion Criteria: Known cardiovascular disease (e.g., coronary artery disease, uncontrolled hypertension Women capable of conception (must be post-menopausal, surgically sterilized, or have adhered to an anti-contraception birth control regimen for at least 1 year) Nicotine use Significant endocrine/metabolic disease Kidney disease Neurological illness Liver disease Medication use affecting appetite and/or metabolism MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMXB-A<br>150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks. | Drug: DMXB-A<br>* 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.<br>* Other names: 3-(2,4-dimethoxybenzylidene anabaseine;|
| Placebo Comparator: Placebo<br>Placebo capsules b.i.d. for 12 weeks. | Other: Placebo<br>* Placebo capsules b.i.d. for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuronal Response to Visual Food Cues | Neuronal response (insula) while viewing visual food cues | 14 weeks | 
| Resting-state Neuronal Response | Neuronal response (default mode network) during rest | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | Body weight | 14 weeks | 
| Fat Mass | Fat mass | 14 weeks | 
| Appetite Rating | Hunger ratings via VAS scale (0-100) | 14 weeks |