Clinical Efficacy of Atomoxetine for Methamphetamine Dependence (ATM)

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. Identifier: NCT01557569
Recruitment Status : Completed
First Posted : March 19, 2012
Results First Posted : December 16, 2016
Last Update Posted : February 9, 2017
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence Drug: Atomoxetine Drug: placebo Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
Active Comparator: Atomoxetine
Group receiving atomoxetine
Drug: 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 Name: strattera

Placebo Comparator: Placebo
Group will receive placebo instead of atomoxetine
Drug: placebo
participants in this group will receive 1 dose of placebo daily for the entire 10-weeks.
Other Name: "sugar pill"

Primary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01557569

United States, Arkansas
UAMS, Psychiatric Research Institute, Center for Addiction Research
Little Rock, Arkansas, United States, 72034
Sponsors and Collaborators
University of Arkansas
National Institute on Drug Abuse (NIDA)
Principal Investigator: Alison Oliveto, PhD University of Arkansas

Responsible Party: University of Arkansas Identifier: NCT01557569     History of Changes
Other Study ID Numbers: 133414
First Posted: March 19, 2012    Key Record Dates
Results First Posted: December 16, 2016
Last Update Posted: February 9, 2017
Last Verified: December 2016

Keywords provided by University of Arkansas:

Additional relevant MeSH terms:
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors