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Nicotinic Agonist Effects on BMI and Neuronal Response

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT02458313
Collaborator
(none)
114
Enrollment
1
Location
2
Arms
68
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Nicotinic Agonist Effects on BMI and Neuronal Response in Overweight/Obese Adults
Actual Study Start Date :
Apr 14, 2016
Actual Primary Completion Date :
Dec 13, 2021
Actual Study Completion Date :
Dec 13, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Neuronal response to visual food cues [14 weeks]

      Neuronal response (insula) while viewing visual food cues

    2. Resting-state neuronal response [14 weeks]

      Neuronal response (default mode network) during rest

    Secondary Outcome Measures

    1. Body weight [14 weeks]

      Body weight

    2. Fat mass [14 weeks]

      Fat mass

    3. Appetite Rating [14 weeks]

      Hunger ratings via VAS scale (0-100)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Denver Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT02458313
    Other Study ID Numbers:
    • 15-0650
    • UL1TR001082
    First Posted:
    Jun 1, 2015
    Last Update Posted:
    Dec 20, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    3-(2,4-dimethoxybenzylidene)anabaseine

    Study Results

    No Results Posted as of Dec 20, 2021