Clinical trial NCT00571103: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pathological Gambling
Keywords: acamprosate, impulse-control disorders
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: University of Nebraska
name: Forest Laboratories
First posted: 2007-12-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Primary Efficacy Measure Was the Yale-Brown Obsessive Compulsive Scale Modified for PG (YBOCS-PG).
timeFrame: 8 weeks minus baseline
Secondary outcomes:
measure: 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.
timeFrame: 8 weeks minus baseline
Other outcomes:
Locations:
Study officials:
affiliation: The University of Iowa Carver College of Medicine
name: Donald W Black, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nebraska
name: Dennis P McNeilly, PsyD
role: PRINCIPAL_INVESTIGATOR
References: