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

Obesity Clinical Trial

Official title:

The Impact of Methadone Maintenance Therapy on Food Intake and Food Reward Processing in Opioid Dependence: An Event-related Brain Potential Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03575273
• Other study ID #: IRB00092798
• Secondary ID: P30DK072488
• Status: Completed
• Phase: N/A
• Start date: February 12, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: December 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Opioid Dependence
• Opioid-Related Disorders

Intervention

Behavioral:
• Sniffin' Sticks Odor Identification and Hedonic Scale
This task measures odor identification accuracy and perceived pleasantness of odors.
• Sucrose Taste Preference Assessment
This task measures participant ratings of sucrose preference.
• Food Preferences Task
Participants rate images of various food stimuli. Variables derived include relative preferences and reaction time (in milliseconds).
• 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.

Locations

Country	Name	City	State
United States	Broadway Center for Addictions	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Mid-Atlantic Nutrition Obesity Research Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-related potentials measured via BrainVision actiCHamp system	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.	At baseline visit
Secondary	Chemosensory Processing	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.	At baseline visit
Secondary	Food Preferences Task	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.	At baseline visit
Secondary	Progressive Ratio Task	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.	At baseline visit