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
|Condition or disease||Intervention/treatment||Phase|
|Individual Differences Pain Stress Impulsivity||Drug: Within-subject assessment of double-blind study drug||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|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|
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)
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360371
|Contact: Kelly E Dunn, Ph.D.||firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University Bayview Medical Campus||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Kelly E Dunn, PhD 410-550-2254 email@example.com|
|Principal Investigator: Kelly Dunn, PhD|
|Principal Investigator:||Kelly E Dunn, Ph.D.||Johns Hopkins University|