Measuring Acute Drug Demand in Humans II

Johns Hopkins University

Status and phase: Withdrawn; Early Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Blinded Study Medication - Condition 3; Drug: Placebo; Drug: Blinded Study Medication - Condition 2; Drug: Blinded Study Medication - Condition 5; Drug: Blinded Study Medication - Condition 1; Drug: Blinded Study Medication - Condition 4

Study type: Interventional

Funder types: Other

Identifiers

NCT07043452

IRB00454735

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

0 participants in 6 patient groups

Experimental Session 1

Experimental group

Description:

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

Treatment:

Drug: Blinded Study Medication - Condition 1

Experimental Session 2

Experimental group

Description:

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

Treatment:

Drug: Blinded Study Medication - Condition 2

Experimental Session 3

Experimental group

Description:

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

Treatment:

Drug: Blinded Study Medication - Condition 3

Experimental Session 4

Experimental group

Description:

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

Treatment:

Drug: Blinded Study Medication - Condition 4

Experimental Session 5

Experimental group

Description:

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

Treatment:

Drug: Blinded Study Medication - Condition 5

Experimental Session 6

Experimental group

Description:

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

Treatment:

Drug: Placebo