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

Tracking Information
First Submitted Date ICMJE	November 3, 2005
First Posted Date ICMJE	November 7, 2005
Last Update Posted Date	October 27, 2017
Actual Study Start Date ICMJE	December 2001
Actual Primary Completion Date	December 2005 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 26, 2017)	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.
Original Primary Outcome Measures ICMJE; (submitted: November 3, 2005)	Decreased gambling behavior; measured throughout study; Decreased alcohol consumption; measured throughout study and at Week 10
Change History	Complete list of historical versions of study NCT00249431 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effectiveness of Sertraline in Treating Pathological Gamblers With a Diagnosis of Alcohol Dependence - 1
Official Title ICMJE	A Pilot Study of Sertraline Plus Relapse Prevention Therapy (RP) for the Treatment of Pathological Gambling With Comorbid Abuse or Dependence
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Alcoholism; Gambling
Intervention ICMJE	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.
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: April 11, 2012)	9
Original Enrollment ICMJE; (submitted: November 3, 2005)	30
Actual Study Completion Date	December 2005
Actual Primary Completion Date	December 2005 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	United States
Administrative Information
NCT Number ICMJE	NCT00249431
Other Study ID Numbers ICMJE	#5156R; 5K23DA000482 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	New York State Psychiatric Institute
Study Sponsor ICMJE	New York State Psychiatric Institute
Collaborators ICMJE	National Institute on Drug Abuse (NIDA)
Investigators ICMJE	Principal Investigator: Carlos Blanco, M.D. Columbia University
PRS Account	New York State Psychiatric Institute
Verification Date	October 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP