Effects of Dietary Conditions on Drug Response

Johns Hopkins University

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: Blinded drug dose conditions

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04315961

R01DA003890 (U.S. NIH Grant/Contract)

IRB00231935

Details and patient eligibility

About

This non-treatment study will examine how different dietary conditions may affect a person's response to commonly used drugs.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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1 participants in 2 patient groups, including a placebo group

Caffeine Maintenance

Experimental group

Description:

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). During the caffeine maintenance condition, participants will ingest 200 mg of caffeine orally in capsules three times daily.

Treatment:

Drug: Blinded drug dose conditions

Placebo Maintenance

Placebo Comparator group

Description:

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). The placebo maintenance condition will be identical to the caffeine maintenance condition, with the exception that the thrice daily capsules will contain placebo (microcrystalline cellulose) rather than containing caffeine.

Treatment:

Drug: Blinded drug dose conditions