Effects of LDX on Cognitive Processes and Appetite

NCT04181957 | Terminated

• 1 other identifier: IRAS 250510
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the effect of lisdexamfetamine dimesylate (LDX) on the mediating factors of reward and cognition on appetite.

Conditions

Binge Eating; Eating Behavior

Outcome Measures

Primary Outcomes (2)

• Metabolic food intake

  We will examine if LDX has an influence on metabolic food intake using a lab-based food task, in which participants eat as much pasta as they like until they feel comfortably full . Amount eaten will be measured in grams.

  15 minutes

• Hedonic food intake

  The effect of LDX on hedonic food intake will be measured via offering a palatable snack of chocolate chip cookies 20 minutes after participants have consumed the pasta. Amount eaten will be measured in grams.

  15 minutes

Secondary Outcomes (11)

• fMRI Reward Processes

  21 minutes

• Ratings

  20 minutes

• Emotional processing

  35 minutes

• Memory

  10 minutes

• Attention

  14 minutes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants receive placebo tablet composed of lactose.

Drug: Placebo oral tablet

Active

ACTIVE COMPARATOR

Participants receive a 50mg tablet of lisdexamfetamine dimesylate (LDX) once.

Drug: Lisdexamfetamine Dimesylate

Interventions

Placebo oral tablet DRUG

Participants take one dose of placebo (lactose) tablet.

Placebo

Lisdexamfetamine Dimesylate DRUG

Participants take one 50mg tablet of lisdexamfetamine dimesylate once.

Active

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Fluent English speakers
• Be willing to be informed of chance pathological findings from the fMRI scan
• Must have binge-eating symptoms that is measured by a minimum score of 18 on the Binge Eating Scale
• Must have a minimum BMI of 18.5
• Must be below 152.4kg
• Must have clearance from a qualified physician before participating

You may not qualify if:

• Symptoms or diagnosis of other eating disorders.
• Psychotherapy and/or pharmacotherapy for binge-eating disorder (BED) 3 months before the study, as this will suggest a diagnosis of BED and may influence eating behaviour.
• Metabolic (e.g. metabolic disorder, diabetes), psychological (e.g. depression), substance, 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, determined through questionnaires in the screening session
• Current smoking, as it can interfere with appetite
• Current pregnancy or breastfeeding
• Not passing a breathalyser test on the morning of testing.
• Food allergies (e.g. peanut allergy, lactose and gluten intolerance) or vegetarian/vegan diet
• Disliking the study lunch to ensure that participants will consume the provided food
• Women will be asked to participate only in weeks when they are not menstruating or in their pre-menstrual week, to avoid hormonal disruption to appetite.
• Non-removable metal object in or on their body, such as: heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
• Left-handed
• Tattoos that are older than 10 years
• Claustrophobia
• Limited temperature perception and/or increased sensitivity to warming of the body

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

University of Birmingham

Birmingham, B152TT, United Kingdom

Location

MeSH Terms

Conditions

Bulimia; Feeding Behavior

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Suzanne Higgs, PhD

  University of 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 is double-blind. The pharmacists have prepared active and placebo capsules of LDX identical in appearance, and a scientist on the project who is not associated with data collection randomises the condition based on a random, counter-balanced design. The resulting capsule's contents are blind to the participant, data collectors, and the prescribing physician.
• 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: November 13, 2019
• First Posted: December 2, 2019
• Study Start: May 1, 2019
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: November 6, 2020

Record last verified: 2019-01

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)