Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Commonly Used Medications on Mood and Choice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652740
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This non-treatment study will examine how commonly used prescription or over-the-counter medications may influence mood and medication preference.

Condition or disease Intervention/treatment Phase
Healthy Drug: Effects of commonly used medications on mood and medication preference Phase 1

Detailed Description:
Volunteers (aim is 36 completers) will participate in a double-blind study conducted over a period of about 14-17 weeks including sessions for screening, food and beverage diary review (Phase 1), drug exposure and choice sessions (Phase 2), and no-choice exposure sessions (Phase 3). During Phases 2 and 3, participants will orally ingest capsules containing varying doses of commonly prescribed over-the-counter medications and/or placebo. 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 proceed to Phase 1 in which participants will be asked to eliminate certain foods and beverages from participants diet, record participants daily food and beverage consumption and attend the laboratory approximately three times per week to discuss participants' food diaries. During Phases 2 and 3 food and beverage restrictions will remain in place and participants will report to the laboratory 2-5 times weekly in order to ingest study capsules and fill out questionnaires (e.g., about participants' current mood). 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are not assigned to different groups/arms [Note: we indicated 2 arms below because the form does not allow masking in a single arm study - 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: As part of instructions during the informed consent process, volunteers will be given a list of drugs they may receive rather than informing them 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.
Primary Purpose: Basic Science
Official Title: Effects of Commonly Used Medications on Mood and Choice
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Within-Subjects Dose Conditions
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.
Drug: Effects of commonly used medications on mood and medication preference
Capsules will contain a commonly prescribed or over-the-counter medication, or placebo. A placebo is an inactive substance that looks like the study drug, but contains no active drug. The capsules given in this study may include sedatives, muscle relaxants, or anti-anxiety medications, stimulant drugs/weight loss medications, and antihistamines. More drugs are listed than will be administered to increase the degree to which volunteers are "blind" to the drugs being studied. Participants will not be informed of the specific drugs they will receive during or after the study. Participants will not receive any drug that is not named as a possible study drug in the written informed consent form. All the study drugs to be administered are legally marketed in the United States.

Experimental: Additional Within-Subjects Dose Conditions
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.
Drug: Effects of commonly used medications on mood and medication preference
Capsules will contain a commonly prescribed or over-the-counter medication, or placebo. A placebo is an inactive substance that looks like the study drug, but contains no active drug. The capsules given in this study may include sedatives, muscle relaxants, or anti-anxiety medications, stimulant drugs/weight loss medications, and antihistamines. More drugs are listed than will be administered to increase the degree to which volunteers are "blind" to the drugs being studied. Participants will not be informed of the specific drugs they will receive during or after the study. Participants will not receive any drug that is not named as a possible study drug in the written informed consent form. All the study drugs to be administered are legally marketed in the United States.




Primary Outcome Measures :
  1. Participant subjective ratings of drug liking (peak change) [ Time Frame: up to 4 hours after capsule ingestion. ]
    Primary outcome will be peak change in participant ratings of drug liking relative to pre-drug ratings within 4 hours post-administration. 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 :
  1. Participant subjective ratings of drug value [ Time Frame: Completed by the participant up to 4 hours after capsule ingestion. ]
    Secondary outcome will be subject rating of monetary drug value as assessed post-administration. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-65
  • 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 30
  • 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
  • Past prescriptions that may affect 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652740


Contacts
Layout table for location contacts
Contact: Darian Weaver 410-550-1927 MedChoiceStudy@jhmi.edu
Contact: Mary M Sweeney, Ph.D. 410-550-3076 msween19@jhmi.edu

Locations
Layout table for location information
United States, Maryland
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Darian Weaver    410-550-1927    medchoicestudy@jhmi.edu   
Principal Investigator: Roland R Griffiths, PhD         
Sub-Investigator: Mary M Sweeney, PhD         
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Roland R Griffiths, Ph.D. Johns Hopkins University

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03652740    
Other Study ID Numbers: IRB00165287
R01DA003890 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not currently a plan to make individual participant data available to other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Johns Hopkins University:
over-the-counter
prescription medication
subjective effects