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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00249431 |
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.
Condition | Intervention | Phase |
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Alcoholism Gambling |
Drug: Sertraline Behavioral: Relapse Prevention Therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Pilot Study of Sertraline Plus Relapse Prevention Therapy (RP) for the Treatment of Pathological Gambling With Comorbid Abuse or Dependence |
Estimated Enrollment: | 30 |
Study Start Date: | December 2001 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Patients will be treated with Relapse Prevention Therapy plus placebo
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Behavioral: Relapse Prevention Therapy
Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.
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2: Active Comparator
Patients will be treated with Relapse prevention Therapy plus Sertraline.
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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.
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Oriana Vesga | (212)543-6514 | vesgaor@nyspi.cpmc.columbia.edu |
United States, New York | |
New York State Psychiatric Institute/Columbia University-2 | Recruiting |
New York, New York, United States, 10023 | |
Contact: Oriana Vesga 212-543-6514 vesgaor@nyspi.cpmc.columbia.edu |
Principal Investigator: | Carlos Blanco, M.D. | Columbia University |
Responsible Party: | New York State Psychiatric Institute ( Carlos Blanco, M.D., Ph.D. ) |
Study ID Numbers: | NIDA-00482-1, K23-00482-1, DPMC |
Study First Received: | November 3, 2005 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00249431 |
Health Authority: | United States: Federal Government |
Impulse Control Disorders Gambling Mental Disorders Alcoholism Substance-Related Disorders |
Sertraline Disorders of Environmental Origin Alcohol-Related Disorders Serotonin Ethanol |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Serotonin Uptake Inhibitors Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |