Clinical Efficacy of Atomoxetine for Methamphetamine Dependence

Methamphetamine Dependence Clinical Trial

— ATM  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557569
• Other study ID #: 133414
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 15, 2012
• Last updated: July 22, 2015
• Start date: April 2012
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. The investigators will also examine the effectiveness of atomoxetine compared to placebo to relieve withdrawal symptoms in methamphetamine dependent participants over a 10-week time period. Our hypothesis is that atomoxetine will improve withdrawal symptoms compared to placebo in methamphetamine dependent participants and that this effect will be associated with an increase in time before (if) the participant relapses.

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 vitals, cognitive assessments, mood assessments, ratings of feelings of withdrawal, urine drug screens, weekly use reports of methamphetamine, and any reports of symptoms or side effects. This will tell the investigators if atomoxetine helps relieve methamphetamine withdrawal symptoms and will tell us if a participant lapsed or relapsed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ß2-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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Methamphetamine Dependence

Intervention

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

Locations

Country	Name	City	State
United States	UAMS, Psychiatric Research Institute, Center for Addiction Research	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time till relapse	The number of days until a participant has a relapse, which will be measure by qualitative urine drug screens.	56 days	No