Dose Response of Mirtazapine to Methamphetamine Induced Interest, Mood Elevation and Reward

NCT00600145 | Withdrawn DMC

• 1 other identifier: 13222
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine if Mirtazapine will produce a decrease in interest in the drug, a decrease in mood elevation, and/or a decrease in reward when given before methamphetamine compared to placebo. Participants will be screened with a psychiatric interview, medical history and physical, laboratory tests, drug of abuse screen and, if female, a urine pregnancy test. They will be provided written informed consent. They will be studied in a within-subjects examination of the subjective mood responses of mirtazapine and methamphetamine. Interactions between methamphetamine and mirtazapine will be assessed by pharmacokinetic studies. Each participant will be introduced to rating scales and cognitive tasks described below. Participants will remain in the research unit for 5 hours on each day that they receive study medication or placebo. They will spend five days in total on the research unit, one day separated by at least one day; then in two day blocks separated by at least one day from another two day block. A venous catheter will be placed for blood draws. Blood pressures and heart rates will be recorded and assessed. Participants will be randomized and double blinded to receive either placebo or mirtazapine orally two hours prior to the administration of randomized and double blinded methamphetamine or placebo in order to have the peak effects of the drugs overlap. VAS-mood, ARCI, GRS, POMS and POMS-E, neurocognitive tasks Trails A and B and Symbol digits modalities test will be administered prior to the mirtazapine or placebo dose, and repeated after the administration of methamphetamine or placebo. After the administration of methamphetamine or placebo, vital signs will be assessed every 15 minutes and the measures will be repeated until 120 minutes have passed from the initial dose of methamphetamine or placebo. Blood will be drawn at one, three and four hour marks for pharmacokinetic testing. This will be repeated on each testing day.

Conditions

Amphetamine Dependence

Keywords

Human volunteers; amphetamine dependence

Outcome Measures

Primary Outcomes (1)

• extent to which mirtazapine reduces methamphetamine induced mood elevation, reward, and interest

  At each study visit

Study Arms (2)

1

EXPERIMENTAL

Mirtazapine

Drug: Mirtazapine

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Mirtazapine DRUG

15 mg Mirtazapine is administered followed 2 hours later by 20 mg of methamphetamine / placebo (administered at each testing visit)

Also known as: Remeron

1

Placebo OTHER

Placebo

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• healthy human volunteers
• no history of pre-existing physical (including cardiovascular) illness
• no history of drug abuse or dependence (defined below)
• ability to read and write

You may not qualify if:

• pregnant
• any psychotropic medication
• criteria for active substance abuse or dependence based on the DSM-IV: For substance abuse: A maladaptive pattern of substance use leading to clinically significant impairment or distress, as manifested by one (or more) of the following, occurring within a 12-month period:
• recurrent substance use resulting in a failure to fulfill major role obligations at work, school, home (e.g., repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; neglect of children or household)
• recurrent substance use in situations in which it is physically hazardous (e.g., driving an automobile or operating a machine when impaired by substance use)
• recurrent substance-related legal problems (e.g., arrests for substance-related disorderly conduct)
• continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (e.g., arguments with spouse about consequences of intoxication, physical fights)
• The symptoms have never met the criteria for Substance Dependence for this class of substances.
• For substance dependence: A maladaptive pattern of substance use, leading to clinically significant impairment or distress, as manifested by three (or more) of the following, occurring at any time in the same 12-month period:
• tolerance, as defined by either of the following:
• a need for markedly increased amounts of the substance to achieve intoxication or desired effect
• markedly diminished effect with continued use of the same amount of substance
• withdrawal, as manifested by either of the following:
• the characteristic withdrawal syndrome for the substance
• the same (or a closely related) substance is taken to relieve or avoid withdrawal symptoms

Sponsors & Collaborators

• University of Virginia: lead
• American Association of Chairs of Departments of Psychiatry: collaborator

Study Sites (1)

Universiyt of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Amphetamine-Related Disorders

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gabrielle Marzani-Nissen, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 24, 2008
• Study Start: September 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: April 27, 2011

Record last verified: 2011-04

Locations

US (1)