Acamprosate in the Treatment of Pathological Gambling
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|ClinicalTrials.gov Identifier: NCT00571103|
Recruitment Status : Completed
First Posted : December 11, 2007
Results First Posted : May 25, 2017
Last Update Posted : May 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pathological Gambling||Drug: acamprosate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label, Flexible Dose 12-Week Clinical Trial of the Safety and Efficacy of Acamprosate in the Treatment of Pathological Gambling|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Experimental: 1 Open Label
Open Label. At visit 2, all participants were started on Acamprosate, 1,998 mg divided into 3 equal doses.
Two 333mg tablets taken three times daily.
Other Name: Campral
- The Primary Efficacy Measure Was the Yale-Brown Obsessive Compulsive Scale Modified for PG (YBOCS-PG). [ Time Frame: 8 weeks minus baseline ]The YBOCS-PG (Yale Brown Obsessive Compulsive Scale modified for Pathological Gambling) is used to assess the range and severity of PG symptoms. The scale is a modification of the YBOCS originally developed by Goodman et al. (1989) for use in rating severity and change in subjects with Obsessive Compulsive Disorder. This adaptation is a 10-item clinician-rated questionnaire, which rates (on a 5-point scale from 0 to 4) time spent, distress, interference, resistance, and control in relation to PG urges and behaviors. The scale ranges from 0 to 40 with a higher score representing increased severity in PG.
- The Secondary Efficacy Evaluations Will Include the G-SAS (Gambling Symptom Assessment Scale), Clinical Global Impression - Improvement Scale (CGI-I) , and the CGI-S Clinical Global Impression - Severity Scale. [ Time Frame: 8 weeks minus baseline ]The G-SAS is a 12 item self-report instrument that reflects the subjects urges to gamble and the subjects gambling behavior. Each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms) with a total score range from 0 to 48. The CGI-I is a 7 point scale requiring the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; and 7, among the most extremely ill patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571103
|Principal Investigator:||Donald W Black, MD||The University of Iowa Carver College of Medicine|
|Principal Investigator:||Dennis P McNeilly, PsyD||University of Nebraska|