Effect of mCPP on Cognitive Control, Appetite, and Neural Responses

NCT03962829 | Terminated

• 1 other identifier: RG_16_214
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies have reported that the 5-HT2C receptor agonist meta-chlorophenylpiperazine (mCPP) decreases appetite and food intake in humans1-3. 5-HT2C receptor activation inhibits dopamine and norepinephrine release in the brain4, and has also been linked to diabetes5. The specificity of the effect of mCPP on human appetite is unclear, as previous studies also reported an increase in nausea1,3. The drug has also been reported to increase anxiety and cause panic attacks when given in a bolus dose intravenously6. Previous findings in our laboratory showed that mCPP reduced appetite, increased satiety in women and enhanced memory in the P1vital® Oxford Emotional Test Battery3. Following up on these results a food intake and fMRI study was performed, in which it was observed that mCPP decreased intake of a palatable snack (hedonic eating) and dlPFC and insula BOLD responses to food pictures. Additionally it increased memory and food value responses in brain after mCPP administration (Thomas et al submitted). It is well established that eating behaviour is affected by metabolic signals (e.g. insulin, ghrelin, serotonin) and is also modulated via food reward processes7. More recently it has been proposed that eating is also modulated via higher cognitive processes such as inhibitory control, attention, and memory. However, in humans, eating behaviour seems to be a more complex process, which involves habits, long-term goals and social interaction. Thus, cognitive processes appear to play an important role in food consumption. In the proposed study the researchers investigate the effect of administering mCPP, on eating, and on metabolic, reward and cognitive processes and the potential interplay between these functions.

Conditions

Eating Behavior; Obesity

Outcome Measures

Primary Outcomes (1)

• fMRI brain response during food reward processes

  Brain responses for food stimuli compared to non-food stimuli. The researchers will measure this by showing subjects food and non-food images while preforming and fMRI-scan and subtract activity during non-food images from the activity pattern when looking at food images.

  21 min

Secondary Outcomes (9)

• fMRI brain response during inhibition processes

  20 min

• Emotional categorisation

  10 min

• Emotional recall part 1

  4 min

• Emotional recall part 1

  10 min

• Pasta intake

  20 min

Study Arms (2)

Placebo condition

PLACEBO COMPARATOR

Participants receive placebo capsule

Drug: Placebo oral tablet

mCPP condition

ACTIVE COMPARATOR

Participants receive active (mCPP) capsule

Drug: mCPP

Interventions

mCPP DRUG

Healthy participants administrate one capsule of mCPP (30mg)

Also known as: meta-chlorophenylpiperazine

mCPP condition

Placebo oral tablet DRUG

Healthy participants administrate one capsule of placebo (containing lactose)

Placebo condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: We aim to recruit 50% male and 50% female particpants
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female subjects
• Age 18-65 years at start of the study
• Body Mass Index (BMI) between 18 and 25 kg/m2 for the lean group and between 30 and 40 kg/m2 for the obese group
• Right-handedness (including left-handers could bias the results because of the laterality of brain functions)
• Ability to give informed consent
• Fluent English speaking
• Willingness to be informed about chance findings of pathology

You may not qualify if:

• Subjects who have a non-removable metal object in or at their body, such as, for example: Heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
• Tattoos, that are older than 15 years
• Claustrophobia
• Limited temperature perception and/or increased sensitivity to warming of the body
• Pathological hearing ability or an increased sensitivity to loud noises
• Lack of ability to give informed consent
• Operation less than three months ago
• Simultaneous participation in other studies that involve drugs intake or blood spending
• Acute illness or infection during the last 4 weeks
• Cardiovascular disorders (e.g., hypertrophic cardiomyopathy, long QT syndrome)
• Moderate or severe head injury
• Eating disorders
• No metabolic (e.g. metabolic disorder, diabetes, insulin resistance), psychological (e.g. depression) or neurological (e.g. epilepsy, headache disorder, multiple sclerosis, traumatic brain injuries) diseases or medication in relation to these diseases.
• Intake of any medication that can interfere with the drug or measurements.
• Current weight loss regimens, or more then 5kg weight loss in the last 3 months

Sponsors & Collaborators

• University of Birmingham: lead
• University Hospital Birmingham: collaborator

Study Sites (1)

University of Birmingham School of Psychology

Birmingham, Midlands, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Feeding Behavior; Obesity

Interventions

1-(3-chlorophenyl)piperazine

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maartje Spetter, PhD

  University fo Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The research will be double blind; both placebo and mCPP will be presented in an identical capsule, therefore the participants and researchers do not know which treatment the participants will receive. A qualified pharmacist will follow standard operating procedures to encase the pharmacy prepared medications in a gelatine capsule in order to match the size and the appearance of the placebo. An independent researcher will prepare counterbalanced randomisation in advance.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: counter-balanced, double-blind, placebo-controlled, crossover, within-subject design

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 24, 2019
• Study Start: February 1, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol and data will become available after the last participant has finished the study.
• Access Criteria: All researchers

Locations

GB (1)