Acamprosate in the Treatment of Pathological Gambling

Pathological Gambling Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571103
• Other study ID #: Black2
• Secondary ID: IRB 200608747
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2007
• Last updated: October 1, 2009
• Start date: October 2007
• Est. completion date: July 2009

Study information

• Verified date: October 2009
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gambling
• Pathological Gambling Disorder

Intervention

Drug:
• acamprosate
Two 333mg tablets taken three times daily.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Iowa	Forest Laboratories, University of Nebraska

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy measure will be be the YBOCS-PG total score.		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).	No
Secondary	The secondary efficacy evaluations will include the GSAS, CGI-R, GAS, and the CGI-S.		Efficacy will be determined by measuring the change from Baseline at Visit 2 to the end of treatment at Visit 8 (week 12).	No