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WithdrawnNCT07043452Updated Nov 12, 2025

Measuring Acute Drug Demand in Humans II

An Early Phase 1 interventional study of Blinded Study Medication - Condition 1 and Blinded Study Medication - Condition 2 in Healthy Volunteers, sponsored by Johns Hopkins University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-12.

Sponsored by Johns Hopkins University · Early Phase 1, Interventional, and Basic science

Why this study was withdrawn
The lead investigator moved institutions and the study will not continue upon his departure.
Phase
Early Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This research is being done to evaluate the impact of various drugs and combinations of drugs on mood, pain, and performance.

Read the detailed description

This research is being done to evaluate the impact of various drugs and combinations of drugs on mood, pain, and performance. Participants will complete 1 screening visit and 7 study test sessions. During the study sessions the participant will receive a study drug that may contain blinded drugs or drug combinations. Participants will answer questions about how the participant feels, perform tasks that measure the participant's cognitive ability and experience of pain, and have heart rate and blood pressure measured. While not at the laboratory, participants will be asked to wear a wristwatch that measures sleep and activity and complete questions about sleep.

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Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Aged 18-55 years
  2. Vital signs in normal range as reviewed by study medical team
  3. Person is willing and able to provide informed consent

Exclusion criteria

Exclusion Criteria:

  1. Evidence of physical dependence on alcohol or benzodiazepines based on tolerance and withdrawal upon cessation of use of alcohol or benzodiazepines reported in the Mini-International Neuropsychiatric Interview (MINI) as well as clinical interviews by medical staff during H\&P.
  2. Seeking treatment for alcohol or substance use
  3. Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity
  4. Active hepatic disease or abnormal liver function tests
  5. Current major depressive disorder or suicidality
  6. Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding. People of childbearing potential will be asked to ensure, and/or the partner use effective forms of contraception for the duration of the study and excluded if unable.
  7. Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.
  8. Contraindications or allergies to study medications
  9. Evidence of recent illicit substance use (i.e., positive urinalysis) at screening for drugs other than cannabis
  10. Seizure disorder or traumatic brain injury (TBI)
  11. Taking medications known to interact with study medications
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Experimental Session 1

    This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.

    Drug: Blinded Study Medication - Condition 1

  • Experimental
    Experimental Session 2

    This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.

    Drug: Blinded Study Medication - Condition 2

  • Experimental
    Experimental Session 3

    This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.

    Drug: Blinded Study Medication - Condition 3

  • Experimental
    Experimental Session 4

    This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.

    Drug: Blinded Study Medication - Condition 4

  • Experimental
    Experimental Session 5

    This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.

    Drug: Blinded Study Medication - Condition 5

  • Experimental
    Experimental Session 6

    This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.

    Drug: Placebo

Interventions

  • DrugBlinded Study Medication - Condition 1

    Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.

    Also known as: stimulant, cannabinoid, benzodiazepine, opioid, sleep medication, over the counter (OTC) medication

  • DrugBlinded Study Medication - Condition 2

    Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.

    Also known as: stimulant, cannabinoid, benzodiazepine, opioid, sleep medication, over-the-counter (OTC) medication

  • DrugBlinded Study Medication - Condition 3

    Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.

    Also known as: stimulant, cannabinoid, benzodiazepine, opioid, sleep medication, over-the-counter (OTC) medication

  • DrugBlinded Study Medication - Condition 4

    Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.

    Also known as: stimulant, cannabinoid, benzodiazepine, opioid, sleep medication, over-the-counter (OTC) medication

  • DrugBlinded Study Medication - Condition 5

    Participants will receive a double-blinded oral study medication as part of the participant's experimental sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, the medications are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). Participants may receive a study drug that contains a prescription stimulant, a prescription cannabinoid (related to the active ingredient in cannabis or marijuana), a benzodiazepine (e.g., anti- anxiety medication), an opioid (e.g., a pain medication), a sleep medication, and/or an over-the-counter medication. The study is deeply blinded so that participants are not aware of possible drug conditions in the study and indication of the study drug names in the clinicaltrials.gov record would comprise the blind of the study. Detailed drug condition information will be added upon completion of study.

    Also known as: stimulant, cannabinoid, benzodiazepine, opioid, sleep medication, over-the-counter (OTC) medication

  • DrugPlacebo

    Double blind administration of placebo.

06

What researchers measure

Primary outcomes

  1. Demand Intensity - Consumption of Blinded Drug at Unconstrained Price as Measured by a Demand Task

    Consumption of blinded drug at unconstrained price as measured by a demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more drug consumption at unconstrained price (a worse outcome).

    Time frame: Upon completion of experimental session (~8 hours post drug administration)

  2. Breakpoint - Maximum price paid for blinded drug as measured by a demand task

    Maximum price paid for blinded drug as measured by a demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate higher price paid (a worse outcome).

    Time frame: Upon completion of experimental session (~8 hours post drug administration)

  3. Cold Pressor Pain - Seconds to withdraw hand from cold pressor

    Seconds to withdraw hand from cold pressor laboratory pain task, where longer time periods reflect higher tolerance to pain.

    Time frame: Baseline and 1, 2, 4, and 6 hours post drug administration

  4. Cognitive Performance assessed by Digit Symbol Substitution Test (DSST)

    Within-subject comparison of study conditions on the Digit Symbol Substitution Test (DSST), a measure of cognitive performance that is sensitive to drug effects, wherein lower percent scores reflect worse performance and suggest greater drug-related impairment.

    Time frame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, and 8 hours post drug administration.

Secondary outcomes

  1. Drug Liking assessed by Visual Analog Scale of Drug Liking

    Ratings on a visual analog scale of drug liking. Minimum value is 0 and maximum value is 100. Higher scores indicate greater drug liking (a worse outcome).

    Time frame: Upon completion of experimental session (~9 hours post drug administration)

07

Study locations

1 site
  • Behavioral Pharmacology Research Unit, Baltimore
    Baltimore, Maryland 21224, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07043452
Lead sponsor
Johns Hopkins University
Responsible party
Sponsor
First posted
Jun 29, 2025
Start date
Nov 15, 2025 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Nov 12, 2025

Study contacts

Justin Stricklahd, PhD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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