Trial Outcomes & Findings for Interactions Between Drug Effects and Environments II (NCT NCT03075501)

Last Updated: 2021-05-19

Results Overview

The amount of time spent in the two testing rooms is assessed during a 10min exploration test conducted at the orientation session (pre-test) and again at the testing session (post-test). Between the pre- and post-tests, participants complete 4 drug administration sessions; 2 with 20mg MA, 2 with 0mg MA. The Paired Group always receives 20mg MA in the room they spent the least time in at pre-test, and 0mg MA in the other room. The Unpaired Group receives 20mg MA and 0mg MA once in each room. The research question is whether the Paired Group spends significantly more time in the room paired with 20mg MA in comparison to the Unpaired Group. Thus, the outcome measure is the difference in time spent in the room paired with drug administration (i.e. the room that they spent the least time in at pre-test) between pre- and post-tests (i.e., post-test time spent - pre-test time spent) which is compared between the groups. NOTE: Time spent is NOT obtained during drug administration sessions.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

133 participants

Primary outcome timeframe

Measured through study completion (maximum 5 weeks).

Results posted on

2021-05-19

Participant Flow

Participants (N=133) were enrolled in the study between November 2015 and May 2018. All procedures were completed at the Human Addiction Pharmacology Laboratory at the University of Illinois at Chicago.

Participants underwent screening procedures to exclude participants who did not meet the study eligibility criteria.

Participant milestones

Participant milestones
Measure	Paired Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room. Paired: Drug conditioning is assessed by pairing drug administration with a given context. Stimulant or sedative: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired	Unpaired Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms. Stimulant or sedative: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired
Overall Study STARTED	89	44
Overall Study COMPLETED	74	35
Overall Study NOT COMPLETED	15	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Paired Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room. Paired: Drug conditioning is assessed by pairing drug administration with a given context. Stimulant or sedative: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired	Unpaired Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms. Stimulant or sedative: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired
Overall Study Scheduling difficulties	15	9

Baseline Characteristics

Interactions Between Drug Effects and Environments II

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paired n=74 Participants Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room. Paired: Drug conditioning is assessed by pairing drug administration with a given context. Stimulant or sedative: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired	Unpaired n=35 Participants Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms. Stimulant or sedative: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired	Total n=109 Participants Total of all reporting groups
Age, Continuous	24.7 years STANDARD_DEVIATION 5.0 • n=5 Participants	25.0 years STANDARD_DEVIATION 4.6 • n=7 Participants	24.8 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	14 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	21 Participants n=7 Participants	71 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	47 Participants n=5 Participants	20 Participants n=7 Participants	67 Participants n=5 Participants
Race/Ethnicity, Customized Race · More than 1	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	74 participants n=5 Participants	35 participants n=7 Participants	109 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured through study completion (maximum 5 weeks).

Population: Video recordings of the exploration tests (used to calculate time spent) were unavailable (corrupted) for at least one test (pre- or post-) for 3 Paired participants and 2 Unpaired participants. Thus, the participant numbers for this analysis are reduced in comparison to the total number of participants who completed the study.

Outcome measures

Outcome measures
Measure	Paired n=71 Participants Participants complete 4 drug administration sessions; 2 each with 20mg MA or 0mg MA (placebo). Paired: Participants always receive MA in the room that they spent the least time in at the pre-test exploration test, and placebo in the other room. MA: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired	Unpaired n=33 Participants Participants complete 4 drug administration sessions; 2 each with 20mg MA or 0mg MA (placebo). Unpaired: Participants receive MA and placebo once in each room i.e., drug administration is not paired with a given room. MA: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired
Change in Time Spent in Drug-paired Room	24.5 seconds Standard Deviation 115.5	6.2 seconds Standard Deviation 122.4

SECONDARY outcome

Timeframe: Self-reported drug effects are measured 30min before drug administration and at 30min intervals after drug administration for 4h during each drug administration session.

Population: Data was analyzed only for participants who had complete data for the primary outcome (time spent).

Self-reported drug effects are measured using standardized questionnaires 30min before capsule administration (baseline) and at 30min intervals after capsule administration for 4h during each drug administration session. The peak change from baseline is calculated for each session and averaged across drug and placebo sessions. A net difference is calculated by subtracting the mean peak change from baseline during placebo sessions from the mean peak change from baseline during drug (20mg MA) sessions. Outcome measure: Subjective stimulation (i.e., feeling alert, aroused, energetic) is measured using the Amphetamine scale of the Addiction Research Center Inventory. Scores range from 0-11 with greater scores indicating greater drug effects.

Outcome measures

Outcome measures
Measure	Paired n=71 Participants Participants complete 4 drug administration sessions; 2 each with 20mg MA or 0mg MA (placebo). Paired: Participants always receive MA in the room that they spent the least time in at the pre-test exploration test, and placebo in the other room. MA: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired	Unpaired n=33 Participants Participants complete 4 drug administration sessions; 2 each with 20mg MA or 0mg MA (placebo). Unpaired: Participants receive MA and placebo once in each room i.e., drug administration is not paired with a given room. MA: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired
Subjective Drug Effects	3.4 units on a scale Standard Deviation 2.5	4.1 units on a scale Standard Deviation 2.5

Adverse Events

20mg Methamphetamine

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

0mg Methamphetamine (Placebo)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	20mg Methamphetamine n=109 participants at risk Participants completed two drug administration sessions with 20mg methamphetamine. Self-reported side effects: At 30min intervals following drug administration (for 4h), they reported any side effects on a paper and pencil form. Drug side effects (Blurred vision, Dry mouth, Headache, Nausea, Heart racing, Shortness of breath, Dizziness/faintness, Restlessness, Chest discomfort, Shakiness or trembling (legs, arms, hands, feet), Pain or numbness in fingers or toes, Anxiety/tension) were each associated with a 100mm visual analogue scale anchored at the left hand side with "None" and at the right hand side with "Extreme". Participants placed a vertical line bisecting the scale that corresponded with how they were feeling at that time. Scores ranged from 0-100, with higher scores indicating more severe side effects. Cardiovascular Measures: Heart rate (bpm) and blood pressure mmHg) were monitored using a monitor 30min before drug administration (baseline) and at 30min intervals (for 4h) following drug administration. Serious adverse events were defined as any side effects reported in the "severe-extreme" range (i.e., \>60) or any occasion when the study physician was consulted about high cardiovascular measures. Serious adverse events are reported for all participants who completed the study (N=109).	0mg Methamphetamine (Placebo) n=109 participants at risk Participants completed two drug administration sessions with 20mg methamphetamine. Self-reported side effects: At 30min intervals following drug administration (for 4h), they reported any side effects on a paper and pencil form. Drug side effects (Blurred vision, Dry mouth, Headache, Nausea, Heart racing, Shortness of breath, Dizziness/faintness, Restlessness, Chest discomfort, Shakiness or trembling (legs, arms, hands, feet), Pain or numbness in fingers or toes, Anxiety/tension) were each associated with a 100mm visual analogue scale anchored at the left hand side with "None" and at the right hand side with "Extreme". Participants placed a vertical line bisecting the scale that corresponded with how they were feeling at that time. Scores ranged from 0-100, with higher scores indicating more severe side effects. Cardiovascular Measures: Heart rate (bpm) and blood pressure mmHg) were monitored using a monitor 30min before drug administration (baseline) and at 30min intervals (for 4h) following drug administration. Serious adverse events were defined as any side effects reported in the "severe-extreme" range (i.e., \>60) or any occasion when the study physician was consulted about high cardiovascular measures. Serious adverse events are reported for all participants who completed the study (N=109).
Cardiac disorders High heart rate and blood pressure	0.92% 1/109 • Up to 5 weeks Participants reported adverse effects during and after sessions.	0.00% 0/109 • Up to 5 weeks Participants reported adverse effects during and after sessions.
Nervous system disorders Dry mouth	5.5% 6/109 • Up to 5 weeks Participants reported adverse effects during and after sessions.	0.92% 1/109 • Up to 5 weeks Participants reported adverse effects during and after sessions.
Nervous system disorders Shakiness/Trembling	1.8% 2/109 • Up to 5 weeks Participants reported adverse effects during and after sessions.	0.00% 0/109 • Up to 5 weeks Participants reported adverse effects during and after sessions.
Cardiac disorders Heart racing	1.8% 2/109 • Up to 5 weeks Participants reported adverse effects during and after sessions.	0.00% 0/109 • Up to 5 weeks Participants reported adverse effects during and after sessions.
Nervous system disorders Dizziness/faintness	0.00% 0/109 • Up to 5 weeks Participants reported adverse effects during and after sessions.	0.92% 1/109 • Up to 5 weeks Participants reported adverse effects during and after sessions.

Other adverse events

Adverse event data not reported

Additional Information

Emma Childs

University of Illinois at Chicago

Phone: 312-355-2726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place