Clinical trial NCT01557569: Clinical Efficacy of Atomoxetine for Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Methamphetamine Dependence
Keywords: methamphetamine
addiction
relapse
atomoxetine
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-03-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time Till Relapse
timeFrame: 57 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: UAMS, Psychiatric Research Institute, Center for Addiction Research
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Alison Oliveto, PhD
role: PRINCIPAL_INVESTIGATOR
References: