Nicotinic Agonist Effects on BMI and Neuronal Response

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: DMXB-A; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jason Tregellas, Ph.D., University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2016
• Primary Completion (Actual): December 13, 2021
• Study Completion (Actual): December 13, 2021

Study Registration Dates

• First Submitted: May 21, 2015
• First Submitted That Met QC Criteria: May 27, 2015
• First Posted (Estimated): June 1, 2015

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; 3-(2,4-dimethoxybenzylidene)anabaseine
• Other Study ID Numbers: 15-0650; UL1TR001082 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO