Nicotinic Agonist Effects on BMI and Neuronal Response

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-14

Study Completion Date

2021-12-13

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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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DMXB-A

150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.

Group Type EXPERIMENTAL

DMXB-A

Intervention Type DRUG

150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.

Placebo

Placebo capsules b.i.d. for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo capsules b.i.d. for 12 weeks

Interventions

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DMXB-A

150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.

Intervention Type DRUG

Placebo

Placebo capsules b.i.d. for 12 weeks

Intervention Type OTHER

Other Intervention Names

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3-(2,4-dimethoxybenzylidene anabaseine

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes