Nicotinic Agonist Effects on BMI and Neuronal Response

Phase 1

Completed

• Conditions: Obesity
• Interventions: Other: Placebo; Drug: DMXB-A

• Registration Number: NCT02458313
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-21
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-06-01
• Study Start: 2016-04-14
• Primary Completion: 2021-12-13
• Study Completion: 2021-12-13
• Results First Submitted: 2023-02-21
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-17
• Last Update Submitted: 2023-05-17
• Results First Posted: 2023-06-12
• Last Update Posted: 2023-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Overweight/obese (BMI > 27)
• Between 21-65 years old

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Neuronal Response to Visual Food Cues	14 weeks	Neuronal response (insula) while viewing visual food cues
Resting-state Neuronal Response	14 weeks	Neuronal response (default mode network) during rest

Secondary Outcome Measures

Name	Time	Method
Body Weight	14 weeks	Body weight
Fat Mass	14 weeks	Fat mass
Appetite Rating	14 weeks	Hunger ratings via VAS scale (0-100)

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Denver, Colorado, United States