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The Impact of Methadone Maintenance Therapy on Food Reward Processing in Opioid Dependence

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ClinicalTrials.gov Identifier: NCT03575273
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Mid-Atlantic Nutrition Obesity Research Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Methadone maintenance therapy (MMT) has shown clear efficacy for relieving opioid withdrawal symptoms and reducing the morbidity and mortality of opioid dependence. A notable phenomenon associated with MMT is increased food intake, enhanced sweet preferences, and weight gain. The underlying neural mechanisms for opioid-related overconsumption are not well understood but are thought to arise from role in 1) increasing the palatability and hedonic aspects of food and 2) diminishing satiety signaling systems. In the proposed project, the investigators will examine methadone's potential role in opioid-related overconsumption of food. The investigators propose to examine eating behavior, sucrose preferences, and an event-related potential (ERP) component that is induced by appetitive motivation for highly rewarding foods in patients with a history of opioid dependence receiving methadone maintenance therapy (O+MMT) and not receiving opioid agonist therapy (O-MMT). A matched sample of obese and overweight adults without history of opioid use (HOC) will also be examined.

Condition or disease Intervention/treatment Phase
Opioid Dependence Obesity Behavioral: Sniffin' Sticks Odor Identification and Hedonic Scale Behavioral: Sucrose Taste Preference Assessment Behavioral: Food Preferences Task Behavioral: Progressive Ratio (PR) Task Procedure: Clinical Electrophysiology Dietary Supplement: Standardized Meal and Hunger and Satiety Ratings Not Applicable

Detailed Description:
Methadone maintenance therapy (MMT) has shown clear efficacy for relieving opioid withdrawal symptoms and reducing the morbidity and mortality of opioid dependence. A notable phenomenon associated with MMT is increased food intake, enhanced sweet preferences, and weight gain. The underlying neural mechanisms for opioid-related overconsumption are not well understood but are thought to arise from role in 1) increasing the palatability and hedonic aspects of food and 2) diminishing satiety signaling systems. In the proposed project, the investigators will examine methadone's potential role in opioid-related overconsumption of food. The investigators propose to examine eating behavior, sucrose preferences, and an event-related potential (ERP) component that is induced by appetitive motivation for highly rewarding foods in patients with a history of opioid dependence receiving methadone maintenance therapy (O+MMT) and not receiving opioid agonist therapy (O-MMT). A matched sample of obese and overweight adults without history of opioid use (HOC) will also be examined. Specifically, group differences in food intake and eating behaviors in the O+MMT group relative to individuals in the O-MMT and HOC group will be examined. Individuals will complete 24-hour dietary food recalls and inventories to characterize eating behavior and food addiction. Participants will complete psychophysical measures of chemosensory functioning of sucrose preference and pleasantness and identification ratings for odors varying in participants' hedonic characteristics. Individuals will also complete validated computer tasks to assess food preferences. Differences in cortical ERPs for high-reward food relative to low-reward food and non-food items will be examined. Event-related potentials will be recorded as participants view photos of rewarding and non-rewarding food items, as well as non-food items. ERP components that index sustained attentional engagement will be measured and compared.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The investigators will recruit thirty individuals meeting criteria for opioid dependence of which 15 will be receiving MMT (O+MMT) and 15 will be on no opioid agonist therapy (O-MMT). The investigators will attempt to match the O-MMT group to the O+MMT group for clinical characteristics and smoking burden. Fifteen obese/overweight adults without history of opioid/substance use will be matched to the patient groups for age, gender, education, smoking and BMI.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Impact of Methadone Maintenance Therapy on Food Intake and Food Reward Processing in Opioid Dependence: An Event-related Brain Potential Study
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Opioid dependence receiving methadone
Patients with a history of opioid dependence receiving methadone maintenance therapy will be administered Sniffin' Sticks Odor Identification and Hedonic Scale, Sucrose Taste Preference Assessment, Food Preferences Task, Progressive Ratio Task, Clinical Electrophysiology, and Standardized Meal and Hunger and Satiety Ratings
Behavioral: Sniffin' Sticks Odor Identification and Hedonic Scale
This task measures odor identification accuracy and perceived pleasantness of odors.

Behavioral: Sucrose Taste Preference Assessment
This task measures participant ratings of sucrose preference.

Behavioral: Food Preferences Task
Participants rate images of various food stimuli. Variables derived include relative preferences and reaction time (in milliseconds).

Behavioral: Progressive Ratio (PR) Task
In the PR task, the subject is required to make an increasing number of operant responses for each successive reward

Procedure: Clinical Electrophysiology
To examine motivated attention in response to food stimuli, brain electrophysiology via event related potentials (ERPs) will be assessed while participants view and rate images of food and non-food items.

Dietary Supplement: Standardized Meal and Hunger and Satiety Ratings
Participants will receive a standardized meal and complete hunger and satiety ratings.

Experimental: Opioid dependence not on methadone
Patients with a history of opioid dependence not current receiving methadone maintenance therapy will be administered Sniffin' Sticks Odor Identification and Hedonic Scale, Sucrose Taste Preference Assessment, Food Preferences Task, Progressive Ratio Task, Clinical Electrophysiology, and Standardized Meal and Hunger and Satiety Ratings
Behavioral: Sniffin' Sticks Odor Identification and Hedonic Scale
This task measures odor identification accuracy and perceived pleasantness of odors.

Behavioral: Sucrose Taste Preference Assessment
This task measures participant ratings of sucrose preference.

Behavioral: Food Preferences Task
Participants rate images of various food stimuli. Variables derived include relative preferences and reaction time (in milliseconds).

Behavioral: Progressive Ratio (PR) Task
In the PR task, the subject is required to make an increasing number of operant responses for each successive reward

Procedure: Clinical Electrophysiology
To examine motivated attention in response to food stimuli, brain electrophysiology via event related potentials (ERPs) will be assessed while participants view and rate images of food and non-food items.

Dietary Supplement: Standardized Meal and Hunger and Satiety Ratings
Participants will receive a standardized meal and complete hunger and satiety ratings.

Active Comparator: Healthy controls
Healthy controls without history of opioid use will be administered Sniffin' Sticks Odor Identification and Hedonic Scale, Sucrose Taste Preference Assessment, Food Preferences Task, Progressive Ratio Task, Clinical Electrophysiology, and Standardized Meal and Hunger and Satiety Ratings
Behavioral: Sniffin' Sticks Odor Identification and Hedonic Scale
This task measures odor identification accuracy and perceived pleasantness of odors.

Behavioral: Sucrose Taste Preference Assessment
This task measures participant ratings of sucrose preference.

Behavioral: Food Preferences Task
Participants rate images of various food stimuli. Variables derived include relative preferences and reaction time (in milliseconds).

Behavioral: Progressive Ratio (PR) Task
In the PR task, the subject is required to make an increasing number of operant responses for each successive reward

Procedure: Clinical Electrophysiology
To examine motivated attention in response to food stimuli, brain electrophysiology via event related potentials (ERPs) will be assessed while participants view and rate images of food and non-food items.

Dietary Supplement: Standardized Meal and Hunger and Satiety Ratings
Participants will receive a standardized meal and complete hunger and satiety ratings.




Primary Outcome Measures :
  1. Event-related potentials measured via BrainVision actiCHamp system [ Time Frame: At baseline visit ]
    Cortical ERPs for high-reward food relative to low-reward food and non-food items will be measured using a BrainVision actiCHamp system (32-channel amplifier). For each group, the grand averages and standard deviations for the late positive potential will be calculated. Group differences in LPP will be assessed within and between picture categories for each arm of the study.


Secondary Outcome Measures :
  1. Chemosensory Processing [ Time Frame: At baseline visit ]
    For the odorants, participants provide a rating of intensity and pleasantness based on a -5 to 5 point scale for each of the 16 markers. Afterwards, averages of all 16 marker scores will be calculated for the mean ratings of intensity and pleasantness. Odor identification accuracy will be assessed for each marker, with the score representing the total items correct out of 16.

  2. Food Preferences Task [ Time Frame: At baseline visit ]
    Participants are showed images of high fat savory, low fat savory, high fat sweet, and low fat sweet foods. Participants must select one of the two pictures to answer the question "which food item do you most want to eat right now." Selection averages of each category and time for selection, for each arm of the study, are automatically calculated by E-Prime software.

  3. Progressive Ratio Task [ Time Frame: At baseline visit ]
    Participants begin with 20 M&Ms and a computer prompt that specifies how many times the mouse must be clicked to earn a piece of candy. Participants can earn as little as desired. The click ratio starts at 10 and geometrically increases in increments of 2 (i.e., 10, 20, 40, 80, etc.). The computer program E-Prime automatically records the participant's work capacity and the administrator records the number of M&Ms left in the cup.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • English-speaking individuals
  • Must be between 18 and 60 years of age
  • For the O+MMT group, participants must be receiving MMT for at least 3 months
  • For the O-MMT group, participants must have concluded their MMT (if applicable) at least three months prior to the date of the screening visit.

Exclusion criteria:

  • Individuals may not have a history of major neurological disorders
  • No unstable medical issues that would affect appetite or blood glucose
  • No pervasive developmental disorder or intellectual disability
  • No significant visual/auditory impairment
  • No history or current episode of psychosis
  • No current opioid abuse
  • No current antipsychotic medication use
  • No major conditions that affect chemosensory function (e.g., history of nasal fracture or respiratory infection)
  • Individuals with contraindication for the EEG will be excluded
  • Individuals who are current pregnant or breastfeeding will not be enrolled
  • For HOC, individuals with history of opioid dependence or current or past psychiatric disorders will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575273


Contacts
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Contact: Vidya Kamath, Ph.D. 410-614-6342 vkamath@jhmi.edu
Contact: Denis Antoine, M.D. 410-550-2796 dantoin1@jhmi.edu

Locations
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United States, Maryland
Broadway Center for Addictions Recruiting
Baltimore, Maryland, United States, 21205
Contact: Kenneth Stoller, M.D.    410-955-5439    kstolle@jhmi.edu   
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Vidya Kamath, Ph.D.    410-614-6342    vkamath@jhmi.edu   
Contact: Denis Antoine, M.D.    410-550-2796    dantoin1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Mid-Atlantic Nutrition Obesity Research Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Vidya Kamath, Ph.D. Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03575273     History of Changes
Other Study ID Numbers: IRB00092798
P30DK072488 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
methadone
opioid dependence
obesity
food reward
olfactory
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Methadone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents