Clinical trial NCT04315961: Effects of Dietary Conditions on Drug Response
Official title: Effects of Dietary Conditions on Drug Response
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: over-the-counter
prescription medication
subjective effects
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-03-20
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a within-subjects design. This study involves administration of drug conditions in different dose sequence orders. All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be different across participants. Participants will be randomly assigned to one of several different dose sequences. As part of instructions during the informed consent process, volunteers will be given a list of drugs volunteers may receive rather than informing volunteers only of the specific drugs being administered. More drugs are listed than will be administered to increase the degree to which volunteers are "blind" to the drugs being studied. Researchers will be blind to the drug conditions on any given session because a pharmacy member with no participant interaction will assign the randomized dose sequence and prepare the study drugs.
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak Participant Subjective Ratings of Drug Liking
timeFrame: Up to 4 hours after capsule ingestion during experimental test session
Secondary outcomes:
measure: Participant Subjective Ratings of Drug Value
timeFrame: Up to 4 hours after capsule ingestion during experimental test session
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mary M Sweeney, PhD
role: PRINCIPAL_INVESTIGATOR
References: