Measuring Acute Drug Demand in Humans II

NCT ID: NCT07043452

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2027-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental Session 1

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

Group Type EXPERIMENTAL

Blinded Study Medication - Condition 1

Intervention Type 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.

Experimental Session 2

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

Group Type EXPERIMENTAL

Blinded Study Medication - Condition 2

Intervention Type 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.

Experimental Session 3

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

Group Type EXPERIMENTAL

Blinded Study Medication - Condition 3

Intervention Type 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.

Experimental Session 4

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

Group Type EXPERIMENTAL

Blinded Study Medication - Condition 4

Intervention Type 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.

Experimental Session 5

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

Group Type EXPERIMENTAL

Blinded Study Medication - Condition 5

Intervention Type 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.

Experimental Session 6

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Double blind administration of placebo.

Interventions

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Blinded 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.

Intervention Type DRUG

Blinded 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.

Intervention Type DRUG

Blinded 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.

Intervention Type DRUG

Blinded 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.

Intervention Type DRUG

Blinded 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.

Intervention Type DRUG

Placebo

Double blind administration of placebo.

Intervention Type DRUG

Other Intervention Names

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stimulant cannabinoid benzodiazepine opioid sleep medication over the counter (OTC) medication stimulant cannabinoid benzodiazepine opioid sleep medication over-the-counter (OTC) medication stimulant cannabinoid benzodiazepine opioid sleep medication over-the-counter (OTC) medication stimulant cannabinoid benzodiazepine opioid sleep medication over-the-counter (OTC) medication stimulant cannabinoid benzodiazepine opioid sleep medication over-the-counter (OTC) medication

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin Stricklahd, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Behavioral Pharmacology Research Unit, Baltimore

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00454735

Identifier Type: -

Identifier Source: org_study_id