Trial record 15 of 29 for:    Open Studies | "Methamphetamine"

Clinical Efficacy of Atomoxetine for Methamphetamine Dependence (ATM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Arkansas
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01557569
First received: March 15, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Methamphetamine Dependence
Drug: Atomoxetine
Drug: placebo
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Time till relapse [ Time Frame: 56 days ] [ Designated as safety issue: No ]
    The number of days until a participant has a relapse, which will be measure by qualitative urine drug screens.


Estimated Enrollment: 80
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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"

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557569

Contacts
Contact: Heidi Charton 5015267969
Contact: Merrie Vannucci 5015268424

Locations
United States, Arkansas
UAMS, Psychiatric Research Institute, Center for Addiction Research Recruiting
Little Rock, Arkansas, United States, 72034
Principal Investigator: Alison Oliveto, PhD         
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Alison Oliveto, PhD University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01557569     History of Changes
Other Study ID Numbers: 133414
Study First Received: March 15, 2012
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Arkansas:
methamphetamine
addiction
relapse
atomoxetine

Additional relevant MeSH terms:
Atomoxetine
Methamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014