Measuring Acute Drug Demand in Humans II

NCT07043452 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: IRB00454735
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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).

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

• 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).

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

• 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.

  Baseline and 1, 2, 4, and 6 hours post drug administration

• 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.

  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

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

Study Arms (6)

Experimental Session 1

EXPERIMENTAL

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 Session 2

EXPERIMENTAL

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 Session 3

EXPERIMENTAL

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 Session 4

EXPERIMENTAL

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 Session 5

EXPERIMENTAL

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 Session 6

EXPERIMENTAL

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

Drug: Placebo

Interventions

Blinded Study Medication - Condition 1 DRUG

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

Experimental Session 1

Blinded Study Medication - Condition 2 DRUG

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

Experimental Session 2

Blinded Study Medication - Condition 3 DRUG

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

Experimental Session 3

Blinded Study Medication - Condition 4 DRUG

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

Experimental Session 4

Blinded Study Medication - Condition 5 DRUG

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

Experimental Session 5

Placebo DRUG

Double blind administration of placebo.

Experimental Session 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Seeking treatment for alcohol or substance use
• Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity
• Active hepatic disease or abnormal liver function tests
• Current major depressive disorder or suicidality
• 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.
• Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.
• Contraindications or allergies to study medications
• Evidence of recent illicit substance use (i.e., positive urinalysis) at screening for drugs other than cannabis
• Seizure disorder or traumatic brain injury (TBI)
• Taking medications known to interact with study medications

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Behavioral Pharmacology Research Unit, Baltimore

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Interventions

Central Nervous System Stimulants; Cannabinoids; Benzodiazepines; Analgesics, Opioid; Nonprescription Drugs; Dosage Forms

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Terpenes; Hydrocarbons; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Narcotics; Central Nervous System Depressants; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Justin Stricklahd, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will use a fully within subjects design (i.e., all subjects were to receive all drug combination conditions in a latin-square randomized order).

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 29, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)