Opioid DependenceNCT03575273
The Impact of Methadone Maintenance Therapy on Food Reward Processing in Opioid Dependence
A study testing Sniffin' Sticks Odor Identification and Hedonic Scale, Sucrose Taste Preference Assessment and Food Preferences Task in people with Opioid Dependence and Obesity, run by Johns Hopkins University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Dependence, Obesity
- What is being tested?
- Sniffin' Sticks Odor Identification and Hedonic Scale, Sucrose Taste Preference Assessment and Food Preferences Task
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2018to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Broadway Center for Addictions
Baltimore, Maryland, 21205
Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Dependence, Obesity
- Being tested
- Sniffin' Sticks Odor Identification and Hedonic Scale, Sucrose Taste Preference Assessment, Food Preferences Task, Progressive Ratio (PR) Task, Clinical Electrophysiology
- Keywords
- methadone, opioid dependence, obesity, food reward, olfactory
- Medical subject headings
- Opioid-Related Disorders, Obesity, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sniffin' Sticks Odor Identification and Hedonic ScaleBehavioural
This task measures odor identification accuracy and perceived pleasantness of odors.
Sucrose Taste Preference AssessmentBehavioural
This task measures participant ratings of sucrose preference.
Food Preferences TaskBehavioural
Participants rate images of various food stimuli. Variables derived include relative preferences and reaction time (in milliseconds).
Progressive Ratio (PR) TaskBehavioural
In the PR task, the subject is required to make an increasing number of operant responses for each successive reward
Clinical ElectrophysiologyProcedure or surgery
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 RatingsDietary supplement
Participants will receive a standardized meal and complete hunger and satiety ratings.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline visit
Secondary outcomes (3)
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.
Measured: At baseline visit
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.
Measured: At baseline visit
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.
Measured: At baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start12 Feb 2018
- Primary completion1 Dec 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Mid-Atlantic Nutrition Obesity Research Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Vidya Kamath, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575273
- Sponsor's protocol ID
- IRB00092798
- Other IDs
- P30DK072488
- Status last verified
- Dec 2020
- First submitted
- 21 Jun 2018
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Methadone Maintenance Therapy on Food Intake and Food Reward Processing in Opioid Dependence: An Event-related Brain Potential Study
- ClinicalTrials.gov ID
- NCT03575273
- Acronym / sponsor ID
- IRB00092798
- Conditions
- Opioid Dependence, Obesity
- Keywords
- methadone, opioid dependence, obesity, food reward, olfactory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Mid-Atlantic Nutrition Obesity Research Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Opioid dependence receiving methadone | Experimental | 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 RatingsPatients 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 |
| Opioid dependence not on methadone | Experimental | 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 RatingsPatients 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 |
| Healthy controls | Active comparator | 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 RatingsHealthy 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sniffin' Sticks Odor Identification and Hedonic ScaleThis task measures odor identification accuracy and perceived pleasantness of odors. | Behavioural | Healthy controls, Opioid dependence not on methadone, Opioid dependence receiving methadone |
| Sucrose Taste Preference AssessmentThis task measures participant ratings of sucrose preference. | Behavioural | Healthy controls, Opioid dependence not on methadone, Opioid dependence receiving methadone |
| Food Preferences TaskParticipants rate images of various food stimuli. Variables derived include relative preferences and reaction time (in milliseconds). | Behavioural | Healthy controls, Opioid dependence not on methadone, Opioid dependence receiving methadone |
| Progressive Ratio (PR) TaskIn the PR task, the subject is required to make an increasing number of operant responses for each successive reward | Behavioural | Healthy controls, Opioid dependence not on methadone, Opioid dependence receiving methadone |
| Clinical ElectrophysiologyTo 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. | Procedure or surgery | Healthy controls, Opioid dependence not on methadone, Opioid dependence receiving methadone |
| Standardized Meal and Hunger and Satiety RatingsParticipants will receive a standardized meal and complete hunger and satiety ratings. | Dietary supplement | Healthy controls, Opioid dependence not on methadone, Opioid dependence receiving methadone |
Primary outcome
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.
3 secondary outcomes
Chemosensory Processing
Time frame: At baseline visit
Food Preferences Task
Time frame: At baseline visit
Progressive Ratio Task
Time frame: At baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vidya Kamath, Ph.D. principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sniffin' Sticks Odor Identification and Hedonic Scale, Sucrose Taste Preference Assessment and Food Preferences Task in people with Opioid Dependence and Obesity, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-related potentials measured via BrainVision actiCHamp system (time frame: At baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.