Effects of Dietary Conditions on Drug Response

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    36
  • sponsor
    Johns Hopkins University
Updated on 11 November 2021
Accepts healthy volunteers

Summary

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

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.

Details
Condition healthy
Treatment Blinded drug dose conditions
Clinical Study IdentifierNCT04315961
SponsorJohns Hopkins University
Last Modified on11 November 2021

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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