Full Text View
Tabular View
No Study Results Posted
Related Studies
Effectiveness of Sertraline in Treating Pathological Gamblers With a Diagnosis of Alcohol Dependence - 1
This study is currently recruiting participants.
Study NCT00249431   Information provided by National Institute on Drug Abuse (NIDA)
First Received: November 3, 2005   Last Updated: September 10, 2009   History of Changes

November 3, 2005
September 10, 2009
December 2001
December 2010   (final data collection date for primary outcome measure)
Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • 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
 
 
 
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.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
  • Alcoholism
  • Gambling
  • Drug: Sertraline
  • Behavioral: Relapse Prevention Therapy
  • Placebo Comparator: Patients will be treated with Relapse Prevention Therapy plus placebo
  • Active Comparator: Patients will be treated with Relapse prevention Therapy plus Sertraline.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
30
December 2010
December 2010   (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
Both
18 Years to 65 Years
No
Contact: Mayumi Okuda (212)543-5132 okudama@nyspi.cpmc.columbia.edu
Contact: Laura Villegas (212)543-5280 villega@nyspi.cpmc.columbia.edu
United States
 
NCT00249431
Carlos Blanco, M.D., Ph.D., New York State Psychiatric Institute
NIDA-00482-1, 5 K23-DA000482-1, DPMCDA
National Institute on Drug Abuse (NIDA)
 
Principal Investigator: Carlos Blanco, M.D. Columbia University
National Institute on Drug Abuse (NIDA)
September 2009

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