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Phase 4 N=28 Treatment

Acamprosate in the Treatment of Pathological Gambling

Pathological Gambling

Bottom Line

View on ClinicalTrials.gov: NCT00571103 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: The Primary Efficacy Measure Was the Yale-Brown Obsessive Compulsive Scale Modified for PG (YBOCS-PG). — -.985 units on a scale — p=0.05

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
acamprosate (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Iowa
Primary completion
Jul 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
The Primary Efficacy Measure Was the Yale-Brown Obsessive Compulsive Scale Modified for PG (YBOCS-PG).		 -.985 0.05
SECONDARY
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.		 -1.117; -.145; -.199 —

Summary

The purpose of this study is to see whether acamprosate (Campral) will curb the desire to gamble in people with pathological gambling disorder.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00571103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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