Pathological GamblingPhase 2/3NCT00132119

Nalmefene Gambling Study: Study of Nalmefene HCl in the Treatment of Pathological Gambling

A Phase 2/3 study testing nalmefene HCl in people with Pathological Gambling, run by Somaxon Pharmaceuticals.

Completed

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

Trial summary

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Pathological Gambling
What is being tested?: nalmefene HCl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 233 participants
Where: No sites listed yet
Study dates: Aug 2005to Aug 2006
Phase: Phase 2/3
Are there results?: None posted in the registry

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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Nalmefene HCl in the Treatment of Pathological Gambling

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

Read the detailed description

Randomized, double-blind, placebo-controlled, parallel-group, multi-centered, outpatient study to assess the efficacy, safety and tolerability of two doses of nalmefene in patients with current diagnosis of pathological gambling.

Conditions: Pathological Gambling
Being tested: nalmefene HCl, Placebo
Medical subject headings: Gambling

What participants receive

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

nalmefene HClDrug
Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.
PlaceboOther
Placebo tablet

Study groups in NCT00132119
Study group	Role	What they receive
1	Experimental	Nalmefene HCl 20 mg Receives: Drug: nalmefene HCl
2	Experimental	Nalmefene HCl 40 mg Receives: Drug: nalmefene HCl
3	Placebo comparator	Placebo Receives: Other: Placebo

What is being measured

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

Assess efficacy in treatment of pathological gambling

Secondary outcomes (1)

Evaluate safety and tolerability in treatment of pathological gambling

Timeline

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

Aug 2005Aug 2006

First posted19 Aug 2005 (estimated)
Study startAug 2005
Primary completionAug 2006
Study completionAug 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pathological GamblingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 233 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00132119
Sponsor's protocol ID: SP-N0406
Status last verified: May 2008
First submitted: 17 Aug 2005
Last updated: 19 May 2008
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Low-Intensity Focused Ultrasound for Gambling Disorder
Gambling Disorder, Gambling Addiction
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
Gambling Disorder
Recruiting
Digital Cognitive Behavioral Therapy for Gambling Disorder
Gambling Disorder, Gambling
RecruitingObservational study
Is Craving a Central Criterion for Diagnosing a Behavioral Addiction?
Addictive Behaviors, Internet Addiction Disorder

All Pathological Gambling trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Nalmefene HCl in the Treatment of Pathological Gambling
ClinicalTrials.gov ID: NCT00132119
Acronym / sponsor ID: SP-N0406
Conditions: Pathological Gambling
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 233 participants (actual)
Lead sponsor: Somaxon PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Aug 2005
Primary completion: Aug 2006 (actual)
Study completion: Aug 2006 (actual)
First posted: 19 Aug 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: nalmefene HClNalmefene HCl 20 mg
2	Experimental	Drug: nalmefene HClNalmefene HCl 40 mg
3	Placebo comparator	Other: PlaceboPlacebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nalmefene HClNalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.	Drug	1, 2
PlaceboPlacebo tablet	Other	3

Primary outcome

Assess efficacy in treatment of pathological gambling

1 secondary outcome

Evaluate safety and tolerability in treatment of pathological gambling

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2008.

Related trials for Pathological Gambling

Not yet recruiting
Low-Intensity Focused Ultrasound for Gambling Disorder
Gambling Disorder, Gambling Addiction
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
Gambling Disorder
Recruiting
Digital Cognitive Behavioral Therapy for Gambling Disorder
Gambling Disorder, Gambling
RecruitingObservational study
Is Craving a Central Criterion for Diagnosing a Behavioral Addiction?
Addictive Behaviors, Internet Addiction Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philip Jochelson, MD study director

Somaxon Pharmaceuticals CMO

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing nalmefene HCl in people with Pathological Gambling, run by Somaxon Pharmaceuticals.

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 1 inclusion and 0 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 19 May 2008. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assess efficacy in treatment of pathological gambling. 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 NCT00132119.

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 19 May 2008.