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

NCT03575273 | Completed

• 2 other identifiers: IRB00092798P30DK072488
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Opioid Dependence; Obesity

Keywords

methadone; opioid dependence; obesity; food reward; olfactory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Chemosensory Processing

  At baseline visit

• Food Preferences Task

  At baseline visit

• Progressive Ratio Task

  At baseline visit

Study Arms (3)

Opioid dependence receiving methadone

EXPERIMENTAL

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; 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

Opioid dependence not on methadone

EXPERIMENTAL

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; 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

Healthy controls

ACTIVE COMPARATOR

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; 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

Interventions

Sniffin' Sticks Odor Identification and Hedonic Scale BEHAVIORAL

This task measures odor identification accuracy and perceived pleasantness of odors.

Healthy controls; Opioid dependence not on methadone; Opioid dependence receiving methadone

Sucrose Taste Preference Assessment BEHAVIORAL

This task measures participant ratings of sucrose preference.

Healthy controls; Opioid dependence not on methadone; Opioid dependence receiving methadone

Food Preferences Task BEHAVIORAL

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

Healthy controls; Opioid dependence not on methadone; Opioid dependence receiving methadone

Progressive Ratio (PR) Task BEHAVIORAL

In the PR task, the subject is required to make an increasing number of operant responses for each successive reward

Healthy controls; Opioid dependence not on methadone; Opioid dependence receiving methadone

Clinical Electrophysiology PROCEDURE

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.

Healthy controls; Opioid dependence not on methadone; Opioid dependence receiving methadone

Standardized Meal and Hunger and Satiety Ratings DIETARY_SUPPLEMENT

Participants will receive a standardized meal and complete hunger and satiety ratings.

Healthy controls; Opioid dependence not on methadone; Opioid dependence receiving methadone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Mid-Atlantic Nutrition Obesity Research Center: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Broadway Center for Addictions

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Obesity; Anosmia

Interventions

potassium channel subfamily K member 3; Hunger

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Vidya Kamath, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 2, 2018
• Study Start: February 12, 2018
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)