HealthyPhase 1NCT04315961
Effects of Dietary Conditions on Drug Response
A Phase 1 study testing Blinded drug dose conditions in people with Healthy, run by Johns Hopkins University at 1 site in United States.
Trial summary
This non-treatment study will examine how different dietary conditions may affect a person's response to commonly used drugs. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blinded drug dose conditions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2020to 2 Feb 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
This non-treatment study will examine how different dietary conditions may affect a person's response to commonly used drugs.
Read the 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.
- Conditions
- Healthy
- Being tested
- Blinded drug dose conditions
- Keywords
- over-the-counter, prescription medication, subjective effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded drug dose conditionsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Blinded drug dose conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 hours after capsule ingestion during experimental test session
Secondary outcomes (1)
Participant Subjective Ratings of Drug Value
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.
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.
Measured: Up to 4 hours after capsule ingestion during experimental test session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start18 Sep 2020
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Why it stopped: Unable to recruit participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Mary M Sweeney, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315961
- Sponsor's protocol ID
- IRB00231935
- Other IDs
- R01DA003890
- Status last verified
- Jul 2024
- First submitted
- 18 Mar 2020
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not currently a plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Conditions on Drug Response
- ClinicalTrials.gov ID
- NCT04315961
- Acronym / sponsor ID
- IRB00231935
- Conditions
- Healthy
- Keywords
- over-the-counter, prescription medication, subjective effects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit participants.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Caffeine Maintenance | Experimental | Drug: Blinded drug dose conditionsAll 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. |
| Placebo Maintenance | Placebo comparator | Drug: Blinded drug dose conditionsAll 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blinded drug dose conditionsCapsules 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. | Drug | Caffeine Maintenance, Placebo Maintenance |
Primary outcome
Peak Participant Subjective Ratings of Drug Liking
Time frame: 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. 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.
1 secondary outcome
Participant Subjective Ratings of Drug Value
Time frame: Up to 4 hours after capsule ingestion during experimental test session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is not currently a plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary M Sweeney, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Blinded drug dose conditions in people with Healthy, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Participant Subjective Ratings of Drug Liking (time frame: Up to 4 hours after capsule ingestion during experimental test session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.