Clinical trial NCT00585169: Memantine Treatment Study of Pathological Gambling
Official title: A Phase II Open-Label Multi-Center Trial of Memantine (Namenda(TM)) Treatment of Pathological Gambling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pathological Gambling
Keywords: Pathological Gambling
Compulsive Gambling
Gambling Addiction
Gambling
Treatment
Memantine
Pharmacology
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: Forest Laboratories
First posted: 2008-01-03
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)
timeFrame: Baseline to study end point (10 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Fairview
state: Minnesota
Study officials:
affiliation: Yale University
name: Marc N. Potenza, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Jon E Grant, MD, JD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grant JE, Chamberlain SR, Odlaug BL, Potenza MN, Kim SW. Memantine shows promise in reducing gambling severity and cognitive inflexibility in pathological gambling: a pilot study. Psychopharmacology (Berl). 2010 Dec;212(4):603-12. doi: 10.1007/s00213-010-1994-5. Epub 2010 Aug 19.