Acamprosate in the Treatment of Pathological Gambling

NCT00571103 | Completed Phase 4 Results

• 1 other identifier: 200608747
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pathological Gambling

Keywords

acamprosate, impulse-control disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  8 weeks minus baseline

Study Arms (1)

1 Open Label

EXPERIMENTAL

Open Label. At visit 2, all participants were started on Acamprosate, 1,998 mg divided into 3 equal doses.

Drug: acamprosate

Interventions

acamprosate DRUG

Two 333mg tablets taken three times daily.

Also known as: Campral

1 Open Label

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead
• University of Nebraska: collaborator
• Forest Laboratories: collaborator

MeSH Terms

Conditions

Gambling; Disruptive, Impulse Control, and Conduct Disorders

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Limitations and Caveats

The sample was relatively small, and there was no comparison group; therefore, our results could have resulted from the placebo effect. Another limitation is the relatively short length of the trial. Furthermore, there were few minority subjects.

Results Point of Contact

• Title: Dr. Donald W Black
• Organization: University of Iowa Carver College of Medicine

donald-black@uiowa.edu

319-3534431

Study Officials

• Donald W Black, MD

  The University of Iowa Carver College of Medicine

  PRINCIPAL INVESTIGATOR

• Dennis P McNeilly, PsyD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 11, 2007
• Study Start: October 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 25, 2017
• Results First Posted: May 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share