Clinical trial NCT03575273: The Impact of Methadone Maintenance Therapy on Food Reward Processing in Opioid Dependence
Official title: The Impact of Methadone Maintenance Therapy on Food Intake and Food Reward Processing in Opioid Dependence: An Event-related Brain Potential Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Dependence
Obesity
Keywords: methadone
opioid dependence
obesity
food reward
olfactory
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Mid-Atlantic Nutrition Obesity Research Center
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-07-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Event-related potentials measured via BrainVision actiCHamp system
timeFrame: At baseline visit
Secondary outcomes:
measure: Chemosensory Processing
timeFrame: At baseline visit
measure: Food Preferences Task
timeFrame: At baseline visit
measure: Progressive Ratio Task
timeFrame: At baseline visit
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Broadway Center for Addictions
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Vidya Kamath, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: