Back to resultsAcamprosate in the Treatment of Pathological Gambling
Primary Purpose
Pathological Gambling
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
acamprosate
Sponsored by
About this trial
This is an interventional treatment trial for Pathological Gambling focused on measuring acamprosate, impulse-control disorders
Eligibility Criteria
Inclusion Criteria:
- Patients will meet DSM-IV (Diagnostic and Statistical Manual 4th Edition) criteria for Pathological Gambling Disorder
- Patients will achieve a SOGS (South Oaks Gambling Screen) 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1 Open Label
Arm Description
Open Label. At visit 2, all participants were started on Acamprosate, 1,998 mg divided into 3 equal doses.
Outcomes
Primary Outcome Measures
The Primary Efficacy Measure Was the Yale-Brown Obsessive Compulsive Scale Modified for PG (YBOCS-PG).
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT00571103
First Posted
December 10, 2007
Last Updated
April 24, 2017
Sponsor
University of Iowa
Collaborators
University of Nebraska, Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00571103
Brief Title
Acamprosate in the Treatment of Pathological Gambling
Official Title
Open Label, Flexible Dose 12-Week Clinical Trial of the Safety and Efficacy of Acamprosate in the Treatment of Pathological Gambling
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
University of Nebraska, Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling
Keywords
acamprosate, impulse-control disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Open Label
Arm Type
Experimental
Arm Description
Open Label. At visit 2, all participants were started on Acamprosate, 1,998 mg divided into 3 equal doses.
Intervention Type
Drug
Intervention Name(s)
acamprosate
Other Intervention Name(s)
Campral
Intervention Description
Two 333mg tablets taken three times daily.
Primary Outcome Measure Information:
Title
The Primary Efficacy Measure Was the Yale-Brown Obsessive Compulsive Scale Modified for PG (YBOCS-PG).
Description
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.
Time Frame
8 weeks minus baseline
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
8 weeks minus baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients will meet DSM-IV (Diagnostic and Statistical Manual 4th Edition) criteria for Pathological Gambling Disorder
Patients will achieve a SOGS (South Oaks Gambling Screen) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald W Black, MD
Organizational Affiliation
The University of Iowa Carver College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dennis P McNeilly, PsyD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share individual participant data.
Learn more about this trial
Acamprosate in the Treatment of Pathological Gambling
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