Healthy Clinical Trial
Official title:
Effects of Dietary Conditions on Drug Response
Verified date | February 2023 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This non-treatment study will examine how different dietary conditions may affect a person's response to commonly used drugs.
Status | Terminated |
Enrollment | 2 |
Est. completion date | February 2, 2023 |
Est. primary completion date | February 2, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak participant subjective ratings of drug liking | 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 | Participant subjective ratings of drug value | 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 |
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