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Effects of Commonly Used Medications on Mood and Medication Preference in Healthy Volunteers
Phase 1
Waitlist Available
Led By Roland R Griffiths, Ph.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completed by the participant up to 4 hours after capsule ingestion.
Awards & highlights
Study Summary
This trial will study how drugs that are commonly taken for other reasons may affect mood and what drugs people prefer.
Who is the study for?
This study is for healthy adults aged 18-65 with a BMI of 18.5 to 35, who are non-smokers and fluent in English. Participants must be able to follow the study's procedures and use appropriate birth control if female. People with serious health conditions, current psychiatric or substance use issues, high blood pressure, or known drug allergies cannot join.Check my eligibility
What is being tested?
The trial examines how certain over-the-counter and prescription medications affect mood and medication preference in individuals without any treatment-related goals.See study design
What are the potential side effects?
Since this is an observational study about commonly used medications' effects on mood and choice rather than testing new treatments, specific side effects are not listed but may include typical reactions to over-the-counter or prescription drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 hours after capsule ingestion.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 hours after capsule ingestion.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Participant subjective ratings of drug liking (peak change)
Secondary outcome measures
Participant subjective ratings of drug value
Trial Design
2Treatment groups
Experimental Treatment
Group I: Within-Subjects Dose ConditionsExperimental Treatment1 Intervention
Participants are not assigned to different groups/arms. 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.
Group II: Additional Within-Subjects Dose ConditionsExperimental Treatment1 Intervention
As described previously, 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. We have created a second "arm" in the description of the trial on ClinicalTrials.gov to designate masking - this study involves administration of drug conditions in different dose sequence orders to which participants are randomly assigned.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Effects of commonly used medications on mood and medication preference
2018
Completed Phase 1
~30
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,256 Previous Clinical Trials
14,820,046 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,568 Total Patients Enrolled
Roland R Griffiths, Ph.D.Principal InvestigatorJohns Hopkins University
7 Previous Clinical Trials
295 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your weight is within a healthy range for your height, neither too low nor too high.You will be asked about your past and present use of food, supplements, medicine, and illegal drugs.You are in good overall health.You do not smoke.You have a mental health or substance abuse problem that may affect your ability to take part in the study.You are allergic to the medication being used in the study.Women must use birth control methods such as condoms, pills, or IUDs during the study.Your blood pressure is too high, with the upper number (systolic) being greater than 140 or the lower number (diastolic) being greater than 90.You have any other serious health condition that may affect how long you live or make it hard to follow the study plan.
Research Study Groups:
This trial has the following groups:- Group 1: Within-Subjects Dose Conditions
- Group 2: Additional Within-Subjects Dose Conditions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT03652740 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Might I be considered a suitable candidate for this clinical experiment?
"Participants should be hale and hearty, aged between 18-65 years old if they wish to be considered for this trial. At present, the research team is seeking around 36 people in total."
Answered by AI
Are minors able to partake in this exploration of treatments?
"This trial specifies that those aged 18 to 65 are the only suitable applicants. However, there are 50 separate trials for minors and 372 additional studies available for elderly patients."
Answered by AI
What is the scope of recruitment for this clinical trial?
"Affirmative, the information posted on clinicaltrials.gov attests that this medical experiment is currently enrolling participants. It was initially listed on October 2nd 2018 and recently updated June 30th 2022; 36 patients are accepted at a single site."
Answered by AI
Has the FDA sanctioned any research on how drugs affect people's moods and preferences?
"The safety and efficacy of the commonly used medications' effects on mood and medication preference was rated a 1, as this is an initial trial with limited data to support it."
Answered by AI
Are there still vacancies for volunteers in this investigation?
"Affirmative; the clinicaltrials.gov website states that this research project is still welcoming test subjects. This experiment was first posted on October 2nd 2018 and most recently updated in June 2022. A total of 36 participants are needed, to be recruited from one location."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I've tried other drugs & nothing works. Hoping to do this study. Thank U.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center: < 24 hours
Average response time
- < 2 Days
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