Effects of Dietary Conditions on Drug Response

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04315961

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arm

32.4

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Blinded drug dose conditions	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a within-subjects design. Participants are not assigned to different groups/arms. 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.This is a within-subjects design. Participants are not assigned to different groups/arms. 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.

Masking:

None (Open Label)

Masking Description:

Please note: This is a double-blind study. The investigators indicated "None (Open Label)" above because this clinical trials website form does not allow masking in a single arm study. 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. Masking: Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Effects of Dietary Conditions on Drug Response

Actual Study Start Date :

Sep 18, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Within-Subjects Dose Conditions 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) and not between arms.	Drug: Blinded drug dose conditions Capsules will contain commonly prescribed or over-the-counter drugs or placebo. Capsules in this study may contain sedatives, muscle relaxants, or anti-anxiety medications, stimulant drugs/weight loss medications, or antihistamines which must remain blinded for the purposes of this study.

Arm

Intervention/Treatment

Experimental: Within-Subjects Dose Conditions

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) and not between arms.

Drug: Blinded drug dose conditions

Capsules will contain commonly prescribed or over-the-counter drugs or placebo. Capsules in this study may contain sedatives, muscle relaxants, or anti-anxiety medications, stimulant drugs/weight loss medications, or antihistamines which must remain blinded for the purposes of this study.

Outcome Measures

Primary Outcome Measures

Peak participant subjective ratings of drug liking [Up to 4 hours after capsule ingestion during experimental test session]
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.

Secondary Outcome Measures

Participant subjective ratings of drug value [Up to 4 hours after capsule ingestion during experimental test session]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

Johns Hopkins University
National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Mary M Sweeney, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT04315961

Other Study ID Numbers:

IRB00231935
R01DA003890

First Posted:

Mar 20, 2020

Last Update Posted:

Mar 18, 2022

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Johns Hopkins University

over-the-counter

prescription medication

subjective effects

Study Results

No Results Posted as of Mar 18, 2022