NCT00132119

Brief Summary

The purpose of this study is to determine if nalmefene is safe and effective in the treatment of pathological gambling.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

May 19, 2008

Status Verified

May 1, 2008

Enrollment Period

1 year

First QC Date

August 17, 2005

Last Update Submit

May 15, 2008

Conditions

Pathological Gambling

Outcome Measures

Primary Outcomes (1)

  • Assess efficacy in treatment of pathological gambling

Secondary Outcomes (1)

  • Evaluate safety and tolerability in treatment of pathological gambling

Study Arms (3)

1

EXPERIMENTAL

Nalmefene HCl 20 mg

Drug: nalmefene HCl

2

EXPERIMENTAL

Nalmefene HCl 40 mg

Drug: nalmefene HCl

3

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

nalmefene HClDRUG

Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.

12
PlaceboOTHER

Placebo tablet

3

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current diagnosis of pathological gambling as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gambling

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Officials

  • Philip Jochelson, MD

    Somaxon Pharmaceuticals CMO

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 17, 2005

First Posted

August 19, 2005

Study Start

August 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

May 19, 2008

Record last verified: 2008-05