Trial Outcomes & Findings for Clinical Efficacy of Atomoxetine for Methamphetamine Dependence (NCT NCT01557569)
NCT ID: NCT01557569
Last Updated: 2017-02-09
Results Overview
The number of days until a participant has a relapse, which will be measured by qualitative urine drug screens. To ensure a large enough sample, those who drop out prior to completing the residential stay will be included in this analysis (with minus days until relapse)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
57 days
Results posted on
2017-02-09
Participant Flow
Participant milestones
| Measure |
Atomoxetine
Group receiving atomoxetine
Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)
|
Placebo
Group will receive placebo instead of atomoxetine
placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
Completed 2-wk Residential Stay
|
3
|
1
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Atomoxetine
Group receiving atomoxetine
Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)
|
Placebo
Group will receive placebo instead of atomoxetine
placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
high blood pressure
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
|
Overall Study
noncompliance with rules of residential
|
0
|
1
|
Baseline Characteristics
Clinical Efficacy of Atomoxetine for Methamphetamine Dependence
Baseline characteristics by cohort
| Measure |
Atomoxetine
n=6 Participants
Group receiving atomoxetine
Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)
|
Placebo
n=7 Participants
Group will receive placebo instead of atomoxetine
placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks.
|
Total
n=13 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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gender
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 57 daysPopulation: Only 4 of 13 finished the 2-week residential stay. Since subjects who drop out are deemed relapsed, all subjects receiving \>/=1 dose of study med were included in the analyses. Those who dropped out before completing the residential stay were considered relapsed by the second day and the date of discharge was subtracted from this relapse date.
The number of days until a participant has a relapse, which will be measured by qualitative urine drug screens. To ensure a large enough sample, those who drop out prior to completing the residential stay will be included in this analysis (with minus days until relapse)
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Group receiving atomoxetine
Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)
|
Placebo
n=7 Participants
Group will receive placebo instead of atomoxetine
placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks.
|
|---|---|---|
|
Time Till Relapse
|
7 Days to Relapse
Interval -10.0 to 57.0
|
-8 Days to Relapse
Interval -12.0 to 27.0
|
Adverse Events
Atomoxetine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atomoxetine
n=6 participants at risk
Group receiving atomoxetine
Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)
|
Placebo
n=7 participants at risk
Group will receive placebo instead of atomoxetine
placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks.
|
|---|---|---|
|
Psychiatric disorders
anxiety
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
sharp apin/tingling in limb
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
General disorders
sleepiness/tiredness
|
16.7%
1/6 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
General disorders
night sweats
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Cardiac disorders
elevated BP (outside parameters)
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Cardiac disorders
elevated BP on 3 separate occasions
|
0.00%
0/6
|
14.3%
1/7 • Number of events 2
|
|
Gastrointestinal disorders
constipation
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
General disorders
insomnia
|
33.3%
2/6 • Number of events 2
|
0.00%
0/7
|
|
Cardiac disorders
rapid heartbeat
|
33.3%
2/6 • Number of events 3
|
0.00%
0/7
|
|
Psychiatric disorders
irritability
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
General disorders
dry mouth
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
General disorders
hot flash
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Cardiac disorders
chest pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
General disorders
labored breathing
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
headache/pain
|
16.7%
1/6 • Number of events 2
|
0.00%
0/7
|
|
Gastrointestinal disorders
nausea/vomiting
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place