Effects of Dietary Conditions on Drug Response

NCT04315961 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: IRB00231935R01DA003890
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

over-the-counter; prescription medication; subjective effects

Outcome Measures

Primary Outcomes (1)

• 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. The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

  Up to 4 hours after capsule ingestion during experimental test session

Secondary Outcomes (1)

• Participant Subjective Ratings of Drug Value

  Up to 4 hours after capsule ingestion during experimental test session

Study Arms (2)

Caffeine Maintenance

EXPERIMENTAL

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.

Drug: Blinded drug dose conditions

Placebo Maintenance

PLACEBO COMPARATOR

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.

Drug: Blinded drug dose conditions

Interventions

Blinded drug dose conditions DRUG

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.

Caffeine Maintenance; Placebo Maintenance

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Limitations and Caveats

Early termination - Study was terminated due to COVID 19 lockdown and subsequent research restrictions.

Results Point of Contact

• Title: Dustin Lee
• Organization: Johns Hopkins University School of Medicine

dlee214@jhmi.edu

410-550-4035

Study Officials

• Mary M Sweeney, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Please note: This is a double-blind 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)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 20, 2020
• Study Start: September 18, 2020
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)