Acamprosate in the Treatment of Pathological Gambling - Tabular View

Tracking Information

First Received Date ^ICMJE

December 10, 2007

Last Updated Date

October 1, 2009

Start Date ^ICMJE

October 2007

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary efficacy measure will be be the YBOCS-PG total score. [ Time Frame: Efficacy will be determined by measuring the change in the total YBOCS-PG score from Baseline (visit 2) to the end of treatment at week 12 (visit 8). ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00571103 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The secondary efficacy evaluations will include the GSAS, CGI-R, GAS, and the CGI-S. [ Time Frame: Efficacy will be determined by measuring the change from Baseline at Visit 2 to the end of treatment at Visit 8 (week 12). ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Acamprosate in the Treatment of Pathological Gambling

Official Title ^ICMJE

Open Label, Flexible Dose 12-Week Clinical Trial of the Safety and Efficacy of Acamprosate in the Treatment of Pathological Gambling

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pathological Gambling Disorder

Intervention ^ICMJE

Drug: acamprosate

Study Arms / Comparison Groups

Experimental: Open Label

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients will meet DSM-IV criteria for Pathological Gambling Disorder
Patients will achieve a SOGS 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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00571103

Responsible Party

Donald W Black, MD, The University of Iowa Carver College of Medicine

Study ID Numbers ^ICMJE

Black2, IRB 200608747

Study Sponsor ^ICMJE

University of Iowa

Collaborators ^ICMJE

University of Nebraska
Forest Laboratories

Investigators ^ICMJE

Principal Investigator:	Donald W Black, MD	The University of Iowa Carver College of Medicine
Principal Investigator:	Dennis P McNeilly, PsyD	University of Nebraska

Information Provided By

University of Iowa

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP