Trial Outcomes & Findings for Drugs Brain and Behavior (DDP) (NCT NCT04642820)

Last Updated: 2025-01-09

Results Overview

Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales are scored on a visual analogue scale (Scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

138 participants

Primary outcome timeframe

Time Frame: Day 1(baseline), 3

Results posted on

2025-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Then Methamphetamine Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive 20 mg methamphetamine. Methamphetamine: Participants will be given 20 mg of Methamphetamine. placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.	MethamphetamineThen Placebo Participants first receive 20 mg methamphetamine at their first session in the laboratory Then will return to the laboratory 72 hours later and will receive placebo. Methamphetamine: Participants will be given 20 mg of Methamphetamine. placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.
Overall Study STARTED	69	69
Overall Study COMPLETED	57	56
Overall Study NOT COMPLETED	12	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drugs Brain and Behavior (DDP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Then Methamphetamine n=57 Participants Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive 20 mg methamphetamine. Methamphetamine: Participants will be given 20 mg of Methamphetamine. placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.	MethamphetamineThen Placebo n=56 Participants Participants first receive 20 mg methamphetamine at their first session in the laboratory Then will return to the laboratory 72 hours later and will receive placebo. Methamphetamine: Participants will be given 20 mg of Methamphetamine. placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.	Total n=113 Participants Total of all reporting groups
Age, Continuous	24.3 years STANDARD_DEVIATION 4.3 • n=5 Participants	25.3 years STANDARD_DEVIATION 3.7 • n=7 Participants	24.8 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	56 participants n=7 Participants	113 participants n=5 Participants

PRIMARY outcome

Timeframe: Time Frame: Day 1(baseline), 3

Outcome measures

Outcome measures
Measure	Placebo n=113 Participants placebo oral tablet: Participants will be given a placebo capsule that will only contain lactose.	Methamphetamine n=113 Participants Methamphetamine: Participants will be given 20 mg of Methamphetamine.
Change in SUbjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ). DEQ Feel - Change from baseline	19.2 score on a scale Standard Deviation 21.6	57.8 score on a scale Standard Deviation 25.7
Change in SUbjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ). DEQ Like - Change from baseline	28.6 score on a scale Standard Deviation 28.0	76.3 score on a scale Standard Deviation 26.5
Change in SUbjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ). DEQ Dislike - Change from baseline	25.2 score on a scale Standard Deviation 28.7	26.8 score on a scale Standard Deviation 25.8
Change in SUbjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ). DEQ High - Change from baseline	13.9 score on a scale Standard Deviation 19.4	48.7 score on a scale Standard Deviation 29.4
Change in SUbjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ). DEQ Want more - Change from baseline	22.3 score on a scale Standard Deviation 28.1	69.1 score on a scale Standard Deviation 28.7

Adverse Events

Placebo Then Methamphetamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MethamphetamineThen Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Harriet de Wit, Principal Investigator

University of Chicago

Phone: 773-702-1234

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place