Acamprosate in the Treatment of Pathological Gambling - Full Text View

Sponsor:	University of Iowa
Collaborators:	University of Nebraska Forest Laboratories
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00571103

Purpose

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

Condition	Intervention	Phase
Pathological Gambling Disorder	Drug: acamprosate	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open Label, Flexible Dose 12-Week Clinical Trial of the Safety and Efficacy of Acamprosate in the Treatment of Pathological Gambling

Resource links provided by NLM:

MedlinePlus related topics: Compulsive Gambling

Drug Information available for: Acamprosate calcium Acamprosate

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	30
Study Start Date:	October 2007
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Open Label	Drug: acamprosate Two 333mg tablets taken three times daily. Other Name: Campral

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571103

Sponsors and Collaborators

University of Iowa

University of Nebraska

Forest Laboratories

Investigators

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

More Information

No publications provided

Responsible Party:	Donald W Black, MD, The University of Iowa Carver College of Medicine
ClinicalTrials.gov Identifier:	NCT00571103 History of Changes
Other Study ID Numbers:	Black2, IRB 200608747
Study First Received:	December 10, 2007
Last Updated:	October 1, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Gambling
Impulse Control Disorders
Mental Disorders
Acamprosate

Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012