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Memantine Treatment Study of Pathological Gambling
This study is currently recruiting participants.
Verified by Yale University, February 2009
First Received: December 25, 2007   Last Updated: February 12, 2009   History of Changes
Sponsors and Collaborators: Yale University
University of Minnesota
Forest Laboratories
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00585169
  Purpose

The goal of the proposed study is to evaluate the efficacy and safety of the drug memantine in individuals with pathological gambling (PG). Thirty subjects with DSM-IV PG will receive 10 weeks of open-label treatment with memantine. The hypothesis to be tested is that memantine will be effective and well tolerated in patients with PG. We hypothesize that memantine will reduce the severity of gambling symptoms and improve patients' overall functioning. This study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.


Condition Intervention Phase
Pathological Gambling
Drug: Memantine Hydrochloride
Phase II

MedlinePlus related topics: Compulsive Gambling
Drug Information available for: Memantine Memantine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Open-Label Multi-Center Trial of Memantine (Namenda(TM)) Treatment of Pathological Gambling

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Improvement in patient overall functioning [ Time Frame: Upon study completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Memantine Hydrochloride
    10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 4 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks.
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Pathological Gambling using the clinician-administered Structured Clinical Interview for Pathological Gambling (SCI-PG) (Grant et al., 2004);
  • Gambling behavior within 2 weeks prior to enrollment;
  • For women, negative results on a urine pregnancy test and stable use of a medically accepted form of contraception.

Exclusion Criteria:

  • Infrequent gambling (i.e. less than one time per week) that does not meet DSM-IV criteria for PG;
  • Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen;
  • History of seizures;
  • Myocardial infarction within 6 months;
  • Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
  • A need for medication other than memantine with possible psychotropic effects or unfavorable interactions;
  • Clinically significant suicidality;
  • Current Axis I disorder determined by the SCID and SCID-compatible modules for impulse control disorders (Grant et al., 2005), except for nicotine dependence;
  • Lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by SCID;
  • Current or recent (past 3 months) DSM-IV substance abuse or dependence;
  • Positive urine drug screen at screening;
  • Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;
  • Previous treatment with memantine;
  • Treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585169

Contacts
Contact: Jennifer D. Bellegarde, New Haven, CT (203) 974-7072 jennifer.bellegarde@yale.edu
Contact: Brian L. Odlaug, Minneapolis, MN (612) 627-4363 odla0019@umn.edu

Locations
United States, Connecticut
Yale University School of Medicine Active, not recruiting
New Haven, Connecticut, United States, 06519
United States, Minnesota
University of Minnesota Medical Center, Fairview Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Brian L. Odlaug     612-627-4363     odla0019@unm.edu    
Contact: Jon E. Grant, MD, JD, MPH     612-273-9736     grant045@umn.edu    
Sponsors and Collaborators
Yale University
University of Minnesota
Forest Laboratories
Investigators
Principal Investigator: Marc N. Potenza, M.D, Ph.D. Yale University
  More Information

Additional Information:
No publications provided

Responsible Party: Yale University School of Medicine ( Marc Potenza, M.D., Ph.D. Principal Investigator )
Study ID Numbers: 0705002703*, HIC 0705002703
Study First Received: December 25, 2007
Last Updated: February 12, 2009
ClinicalTrials.gov Identifier: NCT00585169     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Pathological Gambling
Compulsive Gambling
Gambling Addiction
Gambling
Treatment
Memantine
Pharmacology

Study placed in the following topic categories:
Excitatory Amino Acids
Neurotransmitter Agents
Impulse Control Disorders
Behavior, Addictive
Dopamine
Gambling
Mental Disorders
Memantine
Dopamine Agents

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents
Pharmacologic Actions
Impulse Control Disorders
Gambling
Mental Disorders
Therapeutic Uses
Memantine
Dopamine Agents
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on May 07, 2009