Acamprosate in the Treatment of Pathological Gambling

NCT ID: NCT00571103

Last Updated: 2017-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-07-31

Brief Summary

The purpose of this study is to see whether acamprosate (Campral) will curb the desire to gamble in people with pathological gambling disorder.

Detailed Description

Because the opiate antagonists appear to be effective in the treatment of pathological gambling (PG), it is reasonable to ask whether acamprosate (calcium acetylhomotaurine; Campral), also FDA approved for the treatment of alcoholism, can be used effectively to treat PG. Acamprosate is not an opioid antagonist; rather, it is assumed that its therapeutic effects are due to actions on GABA receptors. Acamprosate is structurally related to 1-glutamic, which is an excitatory neurotransmitter. It has been proposed that acamprosate decreases the effects of the naturally-occuring excitatory neurotransmitter glutamate in the body. Because chronic alcohol consumption disrupts this system, and the changes last many months after alcohol ingestion is stopped, it is possible that acamprosate restores the glutamate system towards normal. Regardless, acamprosate decreases the pleasant "high" associated with alcohol consumption, and thus decreases the frequency of relapse during abstinence. We hypothesize that acamprosate will have similar actions in persons with PG.

Conditions

Pathological Gambling

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 Open Label

Open Label. At visit 2, all participants were started on Acamprosate, 1,998 mg divided into 3 equal doses.

Group Type: EXPERIMENTAL

acamprosate

Intervention Type: DRUG

Two 333mg tablets taken three times daily.

Interventions

acamprosate

Two 333mg tablets taken three times daily.

Intervention Type: DRUG

Other Intervention Names

Campral

Eligibility Criteria

Inclusion Criteria

• Patients will meet DSM-IV (Diagnostic and Statistical Manual 4th Edition) criteria for Pathological Gambling Disorder
• Patients will achieve a SOGS (South Oaks Gambling Screen) score greater than or equal to 5
• Patients will be 18 years old or older
• Patients will speak standard English
• Patients will be able to give written Informed Consent
• Patients will be able to understand and cooperate with study procedures

Exclusion Criteria

• Patients having a current (past 3 months) substance use disorder (except dependence)
• Patients having a Hamilton Depression Rating score of greater than or equal to 18 or a score on #1 (depressed mood) greater than 1.
• Patients having a clinically significant medical illness
• Patients at risk for aggressive or suicidal behavior
• Patients who have received the following interventions within the proscribed time prior to study entry: 1) a monoamine oxidase inhibitor within the previous 21 days; 2) long-acting phenothiazines within the previous 3 months; 3) other psychotropic drugs within the previous 14 days; 4) flu- oxetine within the previous 4 weeks.
• Patients having severe antisocial or borderline personality disorder
• Patients with a past or current diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder, bipolar disorder, or delirium, dementia, or other clinically significant cognitive disorder.
• Patients initiating individual, group, or couple psychotherapy during the three moths prior to study entry (excluding Gambler's Anonymous)
• Patients having prior exposure to acamprosate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: collaborator

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Donald Black

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donald W Black, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Iowa Carver College of Medicine

Dennis P McNeilly, PsyD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Other Identifiers

200608747

Identifier Type: -

Identifier Source: org_study_id