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Clinical Efficacy of Atomoxetine for Methamphetamine Dependence (ATM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557569
First Posted: March 19, 2012
Last Update Posted: February 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Arkansas
Results First Submitted: October 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Methamphetamine Dependence
Interventions: Drug: Atomoxetine
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Atomoxetine   Placebo
STARTED   6 [1]   7 [1] 
Completed 2-wk Residential Stay   3   1 
COMPLETED   1   0 
NOT COMPLETED   5   7 
Adverse Event                2                0 
high blood pressure                0                1 
Withdrawal by Subject                3                5 
noncompliance with rules of residential                0                1 
[1] Those who received at least one dose of medication



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
those that received at least one dose of study medication

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Atomoxetine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   7   13 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6 100.0%      7 100.0%      13 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
     
Female      2  33.3%      3  42.9%      5  38.5% 
Male      4  66.7%      4  57.1%      8  61.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      6 100.0%      7 100.0%      13 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   6   7   13 


  Outcome Measures

1.  Primary:   Time Till Relapse   [ Time Frame: 57 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Recruitment and retention was much more difficult than anticipated. Because of, this too few (3 in ATM and 1 in PLA) were retained through the residential stay to determine efficacy.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Alison Oliveto
Organization: UAMS
phone: 501-526-8441
e-mail: olivetoalison@uams.edu



Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01557569     History of Changes
Other Study ID Numbers: 133414
First Submitted: March 15, 2012
First Posted: March 19, 2012
Results First Submitted: October 24, 2016
Results First Posted: December 16, 2016
Last Update Posted: February 9, 2017