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

This study has been terminated.
(Inability to recruit patients.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00249431
First Posted: November 7, 2005
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
November 3, 2005
November 7, 2005
October 27, 2017
December 2001
December 2005   (Final data collection date for primary outcome measure)
Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale. [ Time Frame: 10 weeks ]
Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale.
  • Decreased gambling behavior; measured throughout study
  • Decreased alcohol consumption; measured throughout study and at Week 10
Complete list of historical versions of study NCT00249431 on ClinicalTrials.gov Archive Site
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Effectiveness of Sertraline in Treating Pathological Gamblers With a Diagnosis of Alcohol Dependence - 1
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Alcoholism
  • Gambling
  • 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
    Other Name: zoloft
  • Behavioral: Relapse Prevention Therapy
    Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.
  • Placebo Comparator: Placebo and Relapse Prevention
    Patients will be treated with Relapse Prevention Therapy plus placebo
    Intervention: Behavioral: Relapse Prevention Therapy
  • Active Comparator: Sertraline and Relapse Prevention
    Patients will be treated with Relapse Prevention Therapy plus Sertraline.
    Interventions:
    • Drug: Sertraline
    • Behavioral: Relapse Prevention Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
December 2005
December 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00249431
#5156R
5K23DA000482 ( U.S. NIH Grant/Contract )
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New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Carlos Blanco, M.D. Columbia University
New York State Psychiatric Institute
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP