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

Primary Purpose

Alcoholism, Gambling

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sertraline
Relapse Prevention Therapy
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Gambling, Alcohol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo and Relapse Prevention

    Sertraline and Relapse Prevention

    Arm Description

    Patients will be treated with Relapse Prevention Therapy plus placebo

    Patients will be treated with Relapse Prevention Therapy plus Sertraline.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 3, 2005
    Last Updated
    October 26, 2017
    Sponsor
    New York State Psychiatric Institute
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00249431
    Brief Title
    Effectiveness of Sertraline in Treating Pathological Gamblers With a Diagnosis of Alcohol Dependence - 1
    Official Title
    A Pilot Study of Sertraline Plus Relapse Prevention Therapy (RP) for the Treatment of Pathological Gambling With Comorbid Abuse or Dependence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Inability to recruit patients.
    Study Start Date
    December 2001 (Actual)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    New York State Psychiatric Institute
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcoholism, Gambling
    Keywords
    Gambling, Alcohol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo and Relapse Prevention
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will be treated with Relapse Prevention Therapy plus placebo
    Arm Title
    Sertraline and Relapse Prevention
    Arm Type
    Active Comparator
    Arm Description
    Patients will be treated with Relapse Prevention Therapy plus Sertraline.
    Intervention Type
    Drug
    Intervention Name(s)
    Sertraline
    Other Intervention Name(s)
    zoloft
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Relapse Prevention Therapy
    Intervention Description
    Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.
    Primary Outcome Measure Information:
    Title
    Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale.
    Description
    Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale.
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlos Blanco, M.D.
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36130734
    Citation
    Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.
    Results Reference
    derived

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

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