Effectiveness of Sertraline in Treating Pathological Gamblers With a Diagnosis of Alcohol Dependence - 1

Phase 2

Terminated

• Conditions: Alcoholism; Gambling
• Interventions: Behavioral: Relapse Prevention Therapy; Drug: Sertraline

• Registration Number: NCT00249431
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2005-11-03
• Study First Submitted QC: 2005-11-03
• Study First Posted: 2005-11-07
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo and Relapse Prevention	Relapse Prevention Therapy	Patients will be treated with Relapse Prevention Therapy plus placebo
Sertraline and Relapse Prevention	Relapse Prevention Therapy	Patients will be treated with Relapse Prevention Therapy plus Sertraline.
Sertraline and Relapse Prevention	Sertraline	Patients will be treated with Relapse Prevention Therapy plus Sertraline.

Primary Outcome Measures

Name	Time	Method
Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale.	10 weeks	Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale.