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

Phase 2TerminatedNCT00249431

New York State Psychiatric Institute9 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alcoholism Gambling

Interventions

SertralineDRUG

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

Relapse Prevention TherapyBEHAVIORAL

Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale.

Time frame: 10 weeks

Data from ClinicalTrials.gov

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