Clinical Efficacy of Atomoxetine for Methamphetamine Dependence

NCT ID: NCT01557569

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-07-31

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.

Conditions

Methamphetamine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Atomoxetine

Group receiving atomoxetine

Group Type: ACTIVE_COMPARATOR

Atomoxetine

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

participants in this group will receive 1 dose of placebo daily for the entire 10-weeks.

Interventions

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)

Intervention Type: DRUG

placebo

participants in this group will receive 1 dose of placebo daily for the entire 10-weeks.

Intervention Type: DRUG

Other Intervention Names

strattera; "sugar pill"

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison Oliveto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

UAMS, Psychiatric Research Institute, Center for Addiction Research

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

133414

Identifier Type: -

Identifier Source: org_study_id