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

December 14, 2020 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
      • Baltimore, Maryland, United States, 21205
        • Broadway Center for Addictions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At baseline visit
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.
At baseline visit
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.
At baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mid-Atlantic Nutrition Obesity Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vidya Kamath, Ph.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00092798
  • P30DK072488 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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