Clinical Efficacy of Atomoxetine for Methamphetamine Dependence

NCT01557569 | Completed Phase 1 Results DMC

• 1 other identifier: 133414
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Dependence

Keywords

methamphetamine; addiction; relapse; atomoxetine

Outcome Measures

Primary Outcomes (1)

• Time Till Relapse

  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)

  57 days

Study Arms (2)

Atomoxetine

ACTIVE COMPARATOR

Group receiving atomoxetine

Drug: Atomoxetine

Placebo

PLACEBO COMPARATOR

Group will receive placebo instead of atomoxetine

Drug: placebo

Interventions

Atomoxetine 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)

Also known as: strattera

Atomoxetine

placebo DRUG

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

Also known as: "sugar pill"

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UAMS, Psychiatric Research Institute, Center for Addiction Research

Little Rock, Arkansas, 72034, United States

Location

MeSH Terms

Conditions

Behavior, Addictive; Recurrence

Interventions

Atomoxetine Hydrochloride; Sugars

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Carbohydrates

Limitations and Caveats

Recruitment and retention was much more difficult than anticipated. Because of, this too few (3 in ATM and 1 in PLA) were retained through the residential stay to determine efficacy.

Results Point of Contact

• Title: Dr. Alison Oliveto
• Organization: UAMS

olivetoalison@uams.edu

501-526-8441

Study Officials

• Alison Oliveto, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 19, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 9, 2017
• Results First Posted: December 16, 2016

Record last verified: 2016-12

Locations

US (1)