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Trial Outcomes & Findings for Safety Assessment of Atomoxetine With MA IV Administration (NCT NCT01019707)

NCT ID: NCT01019707

Last Updated: 2017-06-02

Results Overview

Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

Timepoints post MA infusion

Results posted on

2017-06-02

Participant Flow

Potential subjects will be self-identified as non-treatment seeking MA users recruited via advertisements in online sources and newspapers, on radio stations, and community locations, as well as through referrals from within as well as from outside organizations via flyers, and from past research participants.

MA-dependent, non-treatment seeking subjects only were enrolled in this study. A screening period to assess eligibility criteria was used to determine study eligibility. Study completion involved finishing a 15-day inpatient period,followed by 14+ days washout in community, followed by a second 9-day inpatient period.

Participant milestones

Participant milestones
Measure
Atomoxetine, Then Placebo
In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under atomoxetine for 15 days and then placebo for 9 days after a 14 day wash out. The order of study drug was determined randomly.
Placebo, Then Atomoxetine
In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under placebo for 15 days and then atomoxetine for 9 days after a 14 day wash out. The order of study drug was determined randomly.
First Phase
STARTED
3
3
First Phase
COMPLETED
3
3
First Phase
NOT COMPLETED
0
0
Washout
STARTED
3
3
Washout
COMPLETED
3
1
Washout
NOT COMPLETED
0
2
Second Phase
STARTED
3
1
Second Phase
COMPLETED
3
1
Second Phase
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Assessment of Atomoxetine With MA IV Administration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Total Sample
n=4 Participants
In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under atomoxetine and placebo. The order of study drug was determined randomly.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
37 years
STANDARD_DEVIATION 4.1 • n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
Region of Enrollment
United States
4 participants
n=5 Participants

PRIMARY outcome

Timeframe: Timepoints post MA infusion

Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.

Outcome measures

Outcome measures
Measure
Atomoxetine With MA
n=32 Timepoints
Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
Placebo With MA
n=32 Timepoints
Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
Systolic Blood Pressure
126.2 mm Hg
Standard Deviation 15.3
137.1 mm Hg
Standard Deviation 14.7

PRIMARY outcome

Timeframe: Timepoints post MA infusion

Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.

Outcome measures

Outcome measures
Measure
Atomoxetine With MA
n=32 Timepoints post infusion
Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
Placebo With MA
n=32 Timepoints post infusion
Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
Diastolic Blood Pressure
72.4 mm Hg
Standard Deviation 10.6
79.3 mm Hg
Standard Deviation 13.5

PRIMARY outcome

Timeframe: Timepoints post MA infusion

Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.

Outcome measures

Outcome measures
Measure
Atomoxetine With MA
n=32 Timepoints
Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
Placebo With MA
n=32 Timepoints
Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
Heart Rate
81.3 BPM
Standard Deviation 15.3
82.1 BPM
Standard Deviation 13.2

Adverse Events

Atomoxetine With MA

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Placebo With MA

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Atomoxetine With MA
n=4 participants at risk
Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received infusions of saline and 30mg MA on one study day per medication condition.
Placebo With MA
n=4 participants at risk
Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received infusions of saline and 30mg MA on one study day per medication condition.
General disorders
Headache
25.0%
1/4 • Number of events 1
25.0%
1/4 • Number of events 1
General disorders
Insomnia
50.0%
2/4 • Number of events 2
50.0%
2/4 • Number of events 2
Skin and subcutaneous tissue disorders
Acne
25.0%
1/4 • Number of events 1
0.00%
0/4

Additional Information

Edythe D London

University of California Los Angeles

Phone: 310 825 0606

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place