Acamprosate in the Treatment of Pathological Gambling
The purpose of this study is to see whether acamprosate (Campral) will curb the desire to gamble in people with pathological gambling disorder.
|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|
- 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 ]
- 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 ]
|Study Start Date:||October 2007|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Two 333mg tablets taken three times daily.
Other Name: Campral
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.
|Principal Investigator:||Donald W Black, MD||The University of Iowa Carver College of Medicine|
|Principal Investigator:||Dennis P McNeilly, PsyD||University of Nebraska|