- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04315961
Effects of Dietary Conditions on Drug Response
February 2, 2023 updated by: Johns Hopkins University
This non-treatment study will examine how different dietary conditions may affect a person's response to commonly used drugs.
Study Overview
Detailed Description
Volunteers (aim is 36 completers) will participate in a double-blind study conducted over a period of about 10-12 weeks including sessions for screening, food and beverage diary review, and drug exposure sessions.
During screening, participants will be asked questions about participants' general characteristics including demographic information, mood, and personality.
Participants will also be examined to determine medical eligibility.
Eligible participants will complete diary sessions (4 total), experimental sessions (12 total) and end of study sessions (2 sessions).
At food diary sessions, participants will be asked to eliminate certain foods and beverages from participants' diet, record daily food and beverage consumption and attend the laboratory approximately two times to discuss participants' food diaries.
At these sessions, participants will orally ingest capsules containing commonly prescribed medications, over-the-counter medications, and/or placebo and will receive study capsules in blister packs which participants will take three times daily throughout the study.
During experimental sessions, food and beverage restrictions will remain in place, participants will continue thrice daily capsule administration and will also be exposed to experimental test sessions.
Participants will report to the laboratory 2-3 times weekly in order to ingest study capsules, receive blister packs and fill out questionnaires.
After leaving the laboratory, participants will be asked to fill out surveys remotely in order to describe the effects of that session's capsules on mood and preference.
After completing the first six sessions, participants will receive a mid-study bonus and have a 1-week break from attending sessions, during which participants will continue to swallow capsules thrice daily.
Participants will return to the lab and complete two food diary sessions.
After this, participants will complete experimental test sessions 7-12, where participants will again swallow capsules and complete questionnaires.
After completing experimental test sessions 1-12, participants will complete a final experimental test session to facilitate the study assessment of subjective monetary value of drug conditions.
Finally, participants will return to the laboratory to receive a bonus payment for study completion and to complete an end-of-study questionnaire.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-45 years
- Fluent in written and spoken English and is capable of understanding and complying with the protocol
- Medically healthy
- Non-smoker
- Appropriate dietary/over-the-counter/prescription/illicit drug use history
- Body Mass Index between 18.5 and 34.9
- Appropriate use of birth control in females e.g., barrier methods, hormonal contraceptives, Intra Uterine Devices (IUDs)
Exclusion Criteria:
- Known hypersensitivity to administered drugs
- Current neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary or metabolic disease for which administration of the study drugs would be contraindicated
- Current psychiatric or substance use condition that would interfere with study participation
- Diastolic blood pressure >90 mmHg or a systolic pressure of >140 mmHg
- Use of medications that would interfere with study participation
- Unwilling or unable to comply with the protocol
- Any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage the subjects according to the protocol
- Females: Pregnancy, breastfeeding, or plans to become pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Within-Subjects Dose Conditions
All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be different across participants.
Thus, comparisons of the drug conditions on mood and choice will be compared within-subjects (e.g., between drug and placebo) and not between arms.
|
Capsules will contain commonly prescribed or over-the-counter drugs or placebo.
Capsules in this study may contain sedatives, muscle relaxants, or anti-anxiety medications, stimulant drugs/weight loss medications, or antihistamines which must remain blinded for the purposes of this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak participant subjective ratings of drug liking
Time Frame: Up to 4 hours after capsule ingestion during experimental test session
|
Primary outcome will be peak change in participant ratings of drug liking relative to pre-drug ratings within 4 hours post-administration during experimental test sessions.
Participants rate drug liking on a scale from -4 (dislike very much) to 4 (like very much) where 0 = Neutral or No Effect.
This is not a treatment study, and higher or lower ratings of drug liking do not represent better or worse outcomes.
|
Up to 4 hours after capsule ingestion during experimental test session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant subjective ratings of drug value
Time Frame: Up to 4 hours after capsule ingestion during experimental test session
|
Secondary outcome will be subject rating of monetary drug value as assessed post-administration during experimental test sessions.
Participants will rate the subjective value of the drug on a scale from -$30 (i.e., they would prefer to lose $30 rather than take the drug) to $30 (i.e., they would prefer to take today's drug instead of receiving $30).
This is not a treatment study, and higher or lower ratings of drug value do not represent better or worse outcomes.
|
Up to 4 hours after capsule ingestion during experimental test session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary M Sweeney, PhD, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 18, 2020
Primary Completion (ACTUAL)
February 2, 2023
Study Completion (ACTUAL)
February 2, 2023
Study Registration Dates
First Submitted
March 18, 2020
First Submitted That Met QC Criteria
March 19, 2020
First Posted (ACTUAL)
March 20, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 6, 2023
Last Update Submitted That Met QC Criteria
February 2, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- IRB00231935
- R01DA003890 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is not currently a plan to make individual participant data available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Blinded drug dose conditions
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)Recruiting
-
National Jewish HealthNational Institute on Drug Abuse (NIDA)Active, not recruitingHypnotic Dependence Among Those With InsomniaUnited States
-
Inmunova S.A.Hospital Italiano de Buenos AiresCompletedHealthy VolunteersArgentina
-
Nina la Cour FreieslebenCompleted
-
Hospital del Mar Research Institute (IMIM)Harvard Medical School (HMS and HSDM); Catalan Agency for Health Information... and other collaboratorsUnknownSuicide, Attempted | Suicide | Suicide and Self-harm
-
Washington University School of MedicineThe Task Force for Global Health; Murdoch Children's Research InstituteCompletedScabies | Impetigo | Lymphatic Filariases | Soil Transmitted HelminthsFiji
-
Washington University School of MedicineIndonesia University; Case Western Reserve University; Ministere de la Sante... and other collaboratorsCompletedLymphatic FilariasesFiji, Haiti, India, Indonesia, Papua New Guinea
-
Washington University School of MedicineIndian Council of Medical Research; Case Western Reserve UniversityCompletedDeath to Onchocerciasis and Lymphatic Filariasis (DOLF) Triple Drug Therapy for Lymphatic FilariasisLymphatic FilariasisHaiti, India, Indonesia, Papua New Guinea
-
Vistakon PharmaceuticalsCompletedOcular Hypertension | Open-angle GlaucomaUnited States
-
Fundación Pública Andaluza para la gestión de la...Completed