Trial Outcomes & Findings for Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans (NCT NCT02323048)

Last Updated: 2018-07-26

Results Overview

The Drug 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". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales 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

Target enrollment

90 participants

Primary outcome timeframe

End of study (time 0 and approximately 4 weeks later)

Results posted on

2018-07-26

Participant Flow

Healthy volunteers aged 18-35 were recruited through posters, online and newspaper advertisement, and word-of mouth referrals throughout the community.

Participant milestones

Participant milestones
Measure	Paired, High Reward All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) placebo: Placebo (sugar pill)	Paired, Low Reward All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill)	Paired, no Reward All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill)	Unpaired, High Reward All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill)	Unpaired, Low Reward All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill)
Overall Study STARTED	25	26	23	7	9
Overall Study COMPLETED	24	24	23	7	9
Overall Study NOT COMPLETED	1	2	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paired, High Reward n=24 Participants All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill)	Paired, Low Reward n=24 Participants All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill)	Paired, no Reward n=23 Participants All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill)	Unpaired, High Reward n=7 Participants All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill)	Unpaired, Low Reward n=9 Participants All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill)	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	24 Participants n=7 Participants	23 Participants n=5 Participants	7 Participants n=4 Participants	9 Participants n=21 Participants	87 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Continuous	24.8 years STANDARD_DEVIATION 5.0 • n=5 Participants	23.9 years STANDARD_DEVIATION 3.3 • n=7 Participants	22.8 years STANDARD_DEVIATION 2.3 • n=5 Participants	23.3 years STANDARD_DEVIATION 3.0 • n=4 Participants	24.2 years STANDARD_DEVIATION 3.7 • n=21 Participants	23.8 years STANDARD_DEVIATION 3.7 • n=10 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	49 Participants n=10 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	38 Participants n=10 Participants
Region of Enrollment United States	24 Participants n=5 Participants	24 Participants n=7 Participants	23 Participants n=5 Participants	7 Participants n=4 Participants	9 Participants n=21 Participants	87 Participants n=10 Participants

PRIMARY outcome

Timeframe: End of study (time 0 and approximately 4 weeks later)