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

NCT ID: NCT03575273

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2020-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Opioid Dependence Obesity

Keywords

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methadone opioid dependence obesity food reward olfactory

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Sniffin' Sticks Odor Identification and Hedonic Scale

Intervention Type BEHAVIORAL

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

Sucrose Taste Preference Assessment

Intervention Type BEHAVIORAL

This task measures participant ratings of sucrose preference.

Food Preferences Task

Intervention Type BEHAVIORAL

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

Progressive Ratio (PR) Task

Intervention Type BEHAVIORAL

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

Clinical Electrophysiology

Intervention Type 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.

Standardized Meal and Hunger and Satiety Ratings

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type EXPERIMENTAL

Sniffin' Sticks Odor Identification and Hedonic Scale

Intervention Type BEHAVIORAL

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

Sucrose Taste Preference Assessment

Intervention Type BEHAVIORAL

This task measures participant ratings of sucrose preference.

Food Preferences Task

Intervention Type BEHAVIORAL

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

Progressive Ratio (PR) Task

Intervention Type BEHAVIORAL

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

Clinical Electrophysiology

Intervention Type 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.

Standardized Meal and Hunger and Satiety Ratings

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type ACTIVE_COMPARATOR

Sniffin' Sticks Odor Identification and Hedonic Scale

Intervention Type BEHAVIORAL

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

Sucrose Taste Preference Assessment

Intervention Type BEHAVIORAL

This task measures participant ratings of sucrose preference.

Food Preferences Task

Intervention Type BEHAVIORAL

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

Progressive Ratio (PR) Task

Intervention Type BEHAVIORAL

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

Clinical Electrophysiology

Intervention Type 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.

Standardized Meal and Hunger and Satiety Ratings

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Sniffin' Sticks Odor Identification and Hedonic Scale

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

Intervention Type BEHAVIORAL

Sucrose Taste Preference Assessment

This task measures participant ratings of sucrose preference.

Intervention Type BEHAVIORAL

Food Preferences Task

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

Intervention Type 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

Intervention Type BEHAVIORAL

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.

Intervention Type PROCEDURE

Standardized Meal and Hunger and Satiety Ratings

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mid-Atlantic Nutrition Obesity Research Center

UNKNOWN

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vidya Kamath, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Broadway Center for Addictions

Baltimore, Maryland, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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P30DK072488

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00092798

Identifier Type: -

Identifier Source: org_study_id