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Individual Differences in Drug Response

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ClinicalTrials.gov Identifier: NCT02360371
Recruitment Status : Recruiting
First Posted : February 10, 2015
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This study will evaluate the magnitude of individual differences that exist in human response to a blinded study medication.

Condition or disease Intervention/treatment Phase
Individual Differences Pain Stress Impulsivity Drug: Within-subject assessment of double-blind study drug Phase 2

Detailed Description:
This study will assess a broad range of potential outcomes related to administration of a double-blinded, but FDA-approved study medication. Participants will be required to spend the night on a clinical research unit, located on the Johns Hopkins Bayview Medical Campus, for 4 consecutive nights (Monday - Friday). Participants will undergo daily sessions Tuesday - Friday. Tuesday sessions will consist of taking a study medication in the morning and afternoon, and completing a pain testing session after each study drug administration. Wednesday through Friday sessions will consist of taking a study drug in the morning and providing self-report ratings of drug effects and vital sign measurements (such as blood pressure, pulse) several times for a 6-hour period. The investigators will also collect saliva samples to assess physiological functioning, and will ask you to complete a computerized task to assess levels of functioning.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Basic Science
Official Title: Individual Differences in Drug Response
Actual Study Start Date : April 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Within-subject design
All participants will complete several sessions and within-subject assessment of double-blind study drug will be examined during the study sessions. Order of sessions will be randomized and counter-balanced, but all participants will undergo the same study conditions. Although this is a clinical trial, it does not have an active intervention/treatment component.
Drug: Within-subject assessment of double-blind study drug
Participants will receive a double-blinded study drug as part of their daily sessions and will provide feedback regarding the effects of the drug on various measures. Though the study drug is FDA approved, it is being used here for a non-FDA approved purpose (though the FDA has provided permission to use the drug in this study).
Other Name: Drug name will not be provided (double-blind study drug)




Primary Outcome Measures :
  1. Self-report visual analog ratings of drug liking, high, bad effects, good effects, and observer-rated changes in vital signs (blood pressure, pulse, pupil diameter). [ Time Frame: All data will be collected within the 5-day study. ]
    The investigators will assess whether the double-blinded study drug will produce differences in self-report visual analog ratings of drug effects (e.g., liking, high, bad effects, good effects) and observer-ratings of participant response (e.g., change in blood pressure, pulse, pupil diameter) in participants who express the major or minor allele of a gene of interest. As is true with all medications, it is possible that participants may have a negative reaction to the study drug, however the investigators will screen extensively to prevent participants for whom this may happen from participating and have several procedures in place to reduce the risk to the participant. The investigators have several years experience administering this study drug and are confident in their ability to minimize potential problems as a result of the study drug.

  2. Salivary cortisol [ Time Frame: All data will be collected within the 5-day study. ]
    Salivary samples of the stress hormone cortisol will be collected for several hours following double-blinded study drug administration and investigators will assess whether there are differences in cortisol release among participants who express the major or minor allele of the gene of interest and whether this varies as a function of the double-blinded study drug. This will provide a measure of the natural human pain response system under non-pain conditions.

  3. Impulsivity measured with the self-reported Barratt Impulsivity Scale and computerized delay discounting procedures for monetary rewards [ Time Frame: All data will be collected within the 5-day study. ]
    First, participants will complete a self-report rating of impulsivity upon entry to the study that will be compared as a function of genetic status. Second, participants will complete a computerize task that will assess impulsivity following double-blind administration of the study drug. The investigators will assess whether response on this well-validated task is associated with expressing the major or minor allele of the gene of interest, and whether this varies as a function of the double-blinded study drug.

  4. Pain and analgesia measured in a laboratory based quantitative sensory testing battery, consisting of cold pressor threshold and tolerance, pressure pain threshold and tolerance, and conditioned pain modulation. [ Time Frame: All data will be collected within the 5-day study. ]
    Participants will complete two standardized pain testing sessions after receiving a dose of the double-blinded study drug. The sessions will assess response to a cold pressor task and a task that activates the natural pain response system in the body. The investigators will assess whether detection of pain (pain threshold) and removal of the painful stimulus (pain tolerance) varies as a function of genetic status (expressing the major or minor allele on the gene of interest), and the degree to which administration of the double-blind study drug changes pain threshold and tolerance.


Secondary Outcome Measures :
  1. Sex subgroup effects on all primary outcomes described [ Time Frame: All data will be collected within the 5-day study. ]
    All primary outcomes will be evaluated again in male and female subgroups to assess the role of participant sex on study outcomes.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults (21 or older) able to participate in a 5-day residential study

Exclusion Criteria:

  • Being contraindicated for blinded study drug; chronic pain; illicit drug use; pregnancy or breastfeeding

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): NCT02360371


Contacts
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Contact: Kelly E Dunn, Ph.D. 410-550-2254 kdunn9@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Bayview Medical Campus Recruiting
Baltimore, Maryland, United States, 21224
Contact: Kelly E Dunn, PhD    410-550-2254    kdunn@jhmi.edu   
Principal Investigator: Kelly Dunn, PhD         
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Kelly E Dunn, Ph.D. Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02360371     History of Changes
Other Study ID Numbers: IRB00047423
R01DA035246-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

Additional relevant MeSH terms:
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Impulsive Behavior