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Pathological GamblingPhase 2NCT00585169

Memantine Treatment Study of Pathological Gambling

A Phase 2 study testing Memantine Hydrochloride in people with Pathological Gambling, run by Yale University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Pathological Gambling
What is being tested?
Memantine Hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesUnited States
Study dates
Dec 2007to Dec 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Minnesota Medical Center, Fairview

    Minneapolis, Minnesota, 55454

  • Yale University School of Medicine

    New Haven, Connecticut, 06519

Other trials in United States

About this study

Official title: A Phase II Open-Label Multi-Center Trial of Memantine (Namenda(TM)) Treatment of Pathological Gambling

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.

Being tested
Memantine Hydrochloride
Keywords
Pathological Gambling, Compulsive Gambling, Gambling Addiction, Gambling, Treatment, Memantine, Pharmacology
Medical subject headings
Gambling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Memantine HydrochlorideDrug

    Also called Namenda

    10 mg/day for two weeks, dose increase to 20 mg at week 3, 30 mg at week 4 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks.

Study groups in NCT00585169
Study groupRoleWhat they receive
memantineExperimental10 to 30 mg/day memantine. The study consisted of 10 weeks of open-label memantine. All eligible study subjects were started at 10 mg/day for 2 weeks. The dose was increased to 20 mg/day after 2 weeks and then to 30 mg/day after 4 weeks unless remission of PG symptoms was attained at a lower dose.
Receives: Drug: Memantine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)

    The PGYBOCS is a reliable \& valid, 10-item, clinician administered scale that rates gambling symptoms within the last 7 days. The first 5 questions assess urges and thoughts associated with pathological gambling, and the last 5 questions assess the behavioral component of the disorder. Scores of 0 through 4 are assigned each item according to the severity of the response (0 = least severe response or none, 4 = most severe response or extreme)with a score ranging from 0-40. Each set of questions (1-5 and 6-10) can be totaled separately for the component score (urges/thoughts and behavioral) as well as together for a total score. A score of 0 indicates no problems while increasing scores indicate increasing severity of problems with gambling. PG-YBOCS is used to measure changes across time. A decreasing score indicates a possible positive response to the intervention. Total score at baseline was compared with the study end to determine if the intervention was efficacious.

    Measured: Baseline to study end point (10 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00585169
Sponsor's protocol ID
0705002703*
Other IDs
HIC 0705002703
Status last verified
Mar 2013
First submitted
25 Dec 2007
Last updated
8 Apr 2013
Data monitoring committee
No

Publications

  • 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.

    PubMed 20721537

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Memantine Hydrochloride in people with Pathological Gambling, run by Yale University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) (time frame: Baseline to study end point (10 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00585169, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2013.

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