Acamprosate in the Treatment of Pathological Gambling

Open Label, Flexible Dose 12-Week Clinical Trial of the Safety and Efficacy of 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 Overview

• Status: Completed
• Conditions: Pathological Gambling
• Intervention / Treatment: Drug: acamprosate

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 Open Label; Open Label. At visit 2, all participants were started on Acamprosate, 1,998 mg divided into 3 equal doses.	Drug: acamprosate; Two 333mg tablets taken three times daily.; Other Names: Campral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks minus baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks minus baseline

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: Forest Laboratories; University of Nebraska
• Investigators: Principal Investigator: Donald W Black, MD, The University of Iowa Carver College of Medicine; Principal Investigator: Dennis P McNeilly, PsyD, University of Nebraska

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: December 10, 2007
• First Submitted That Met QC Criteria: December 10, 2007
• First Posted (Estimate): December 11, 2007

Study Record Updates

• Last Update Posted (Actual): May 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: acamprosate, impulse-control disorders
• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Gambling; Alcohol Deterrents; Acamprosate
• Other Study ID Numbers: 200608747

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We do not plan to share individual participant data.