- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01557569
Clinical Efficacy of Atomoxetine for Methamphetamine Dependence (ATM)
December 16, 2016 updated by: University of Arkansas
The purpose of this study is to examine the ability of atomoxetine compared to placebo to increase time to relapse in methamphetamine dependent volunteers.
Our hypothesis is that atomoxetine will increase time before (if) the participant relapses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
During the study participants will spend the initial 2-weeks of the study at an inpatient facility.
This will help participants initiate withdrawal.
During the following 8-weeks the participant will come in for 3-4 visits each week.
Three of these visits will be with the research assistants and one visit will be with a therapist in order to work with the participant using a cognitive behavioral therapy approach.
Therapy visits are typically scheduled on a day that the participant is coming for clinic anyways so the number of visits per week is typically 3.
During the 10-week period the investigators will collect various measures, including vitals, cognitive assessments, mood assessments, urine drug screens, weekly use reports of methamphetamine, and any reports of symptoms or side effects.
This will tell the investigators if atomoxetine is safe and if a participant lapsed or relapsed.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arkansas
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Little Rock, Arkansas, United States, 72034
- UAMS, Psychiatric Research Institute, Center for Addiction Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria.
- 18-65 years old
- Seeking treatment for METH use
- METH dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV.
- At least weekly self-reported METH use during a preceding three month period
- Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing, and not be nursing
- Men must agree to use effective means of contraception during the study.
Exclusion Criteria.
- Suicide attempts within the past 12 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician.
- Current opioid, alcohol or sedative physical dependence or cocaine dependence
- Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, hypertension [i.e., > 160 SBP or > 100 DBP] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician.
- Schizophrenia or bipolar disorder of any type
- Present or recent use (within 2 weeks) of over-the-counter or prescription drug that would be expected to have major interaction with atomoxetine (e.g., an monoamine oxidase inhibitor (MAOI), paroxetine, fluoxetine, quinidine, dopamine, albuterol, or other β2-agonists)
- Medical contraindication to receiving atomoxetine (e.g., severe hepatic impairment, glaucoma, heart disease, hypertension, seizure disorders, documented hypersensitivity to atomoxetine); or other bronchospastic condition, (2nd or 3rd degree AV block, sick sinus rhythm, severe hepatic impairment, documented hypersensitivity to atomoxetine)
- Liver function tests (i.e., liver enzymes) greater than two times normal levels
- Systolic blood pressure of < 90 or > 160 mmHg, diastolic blood pressure of < 60 or > 100 mmHg, or sitting heart rate of < 55 or > 100 beats/min or blood pressure readings > 140 systolic or > 90 diastolic on three separate, consecutive occasions.
- History of pheochromocytoma
- Pregnant or nursing female
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Atomoxetine
Group receiving 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)
Other Names:
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Placebo Comparator: Placebo
Group will receive placebo instead of atomoxetine
|
participants in this group will receive 1 dose of placebo daily for the entire 10-weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time Till Relapse
Time Frame: 57 days
|
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)
|
57 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
March 15, 2012
First Submitted That Met QC Criteria
March 16, 2012
First Posted (Estimate)
March 19, 2012
Study Record Updates
Last Update Posted (Estimate)
February 9, 2017
Last Update Submitted That Met QC Criteria
December 16, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 133414
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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