Official Title: “A Pilot Study of Sertraline Plus Relapse Prevention Therapy (RP) for the Treatment of Pathological Gambling With Comorbid Abuse or Dependence”

Pathological gamblers often are also dependent on alcohol and clinically depressed.

Sertraline (Zoloft) is currently used to treat depression, panic disorder, and obsessive-compulsive disorder. The purpose of this trial is to determine the effectiveness of sertraline used in combination with relapse prevention therapy in decreasing gambling behavior and alcohol consumption in individuals with a diagnosis of pathological gambling and alcohol abuse or dependence.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2009

Alcohol abuse and depression commonly occur in conjunction with pathological gambling.

Sertraline (Zoloft) is a selective serotonin reuptake inhibitor (SSRI) currently used to treat depression, panic disorder, and obsessive-compulsive disorder. The purpose of this trial is to determine the effectiveness of sertraline combined with relapse prevention therapy in decreasing gambling behavior and alcohol abuse.

Participants in this 10-week trial will be randomly assigned to receive either relapse prevention (RP) therapy and sertraline or RP therapy and a placebo. Participants will begin taking 25 mg of either sertraline or placebo in a single morning dose for one week. If, after one week, participants do not show improvement, the dose will increase to 50 mg per day during Week 2, and will increase by 50 mg per day every week thereafter to a maximal dose of 200 mg per day.

Weekly hour-long study visits will include a medication evaluation, RP therapy, and questionnaires. In addition, evaluations at baseline, Week 5, and Week 10 will include pathological gambling and depression ratings, urine drug screens, and biochemical measures of alcohol consumption and liver function. All other weekly study visits will include evaluation of side effects, an interview on alcohol use, measures related to obsessive-compulsive drinking, and assessments of vital signs and concomitant medications.

Intervention(s) in this Clinical Trial

• Drug: Sertraline
  • Patients will be started on 25mg/day of Sertraline, and their dose will be increased to 50 mg/day by week two, and then weekly by 50mg/day based on clinical response and emergence of side effects. The maximum dose will be 200mg/day
• Behavioral: Relapse Prevention Therapy
  • Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Patients will be treated with Relapse Prevention Therapy plus placebo
• Active Comparator: 2
  • Patients will be treated with Relapse prevention Therapy plus Sertraline.

Primary Measures

• Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale.
  • Time Frame: 10 weeks
    Safety Issue?: No

Inclusion Criteria:

• Meets DSM-IV criteria for pathological gambling
• Meets DSM-IV and SCID criteria for alcohol abuse or dependence
• Medically healthy

Exclusion Criteria:

• History of schizophrenia, schizoaffective disorder, or bipolar disorder
• Current diagnosis of substance abuse or dependence, other than alcohol or nicotine
• Current major depression
• Currently suicidal
• History of non-response to an adequate trial of sertraline, defined as 200 mg per day of sertraline for at least a 4-week period
• Previous treatment with relapse prevention therapy for pathological gambling or alcohol dependence within the 3 months prior to study entry
• Requires treatment with psychotropic medication
• Unwilling to consent to a drug-free period, according to the following: 2 weeks of abstinence from antidepressant drugs, other than fluoxetine, buspirone, lithium, anticonvulsants, barbiturates, opiates, or benzodiazepines; 4 weeks of abstinence from clonazepam; 5 weeks of abstinence from fluoxetine
• Clinically significant disorder, including kidney, pulmonary, cerebral vascular, cardiovascular, gastrointestinal, and endocrine disorders
• Abnormal laboratory tests
• Abnormal electrocardiogram
• Pregnant or breastfeeding
• Unwilling to use an adequate method of contraception for the duration of the study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Carlos Blanco, M.D. Principal Investigator Columbia University  

Overall Contact: Oriana Vesga (212)543-6514 vesgaor@nyspi.cpmc.columbia.edu

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00249431

Study ID Number: NIDA-00482-1

ClinicalTrials.gov Identifier: NCT00249431

Health Authority: United States: Federal Government