Status:
TERMINATED
Effects of Dietary Conditions on Drug Response
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This non-treatment study will examine how different dietary conditions may affect a person's response to commonly used drugs.
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 expos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04315961
Start Date
September 18 2020
End Date
February 2 2023
Last Update
August 9 2024
Active Locations (1)
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1
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224