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

October 26, 2017 updated by: New York State Psychiatric Institute

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo and Relapse Prevention
Patients will be treated with Relapse Prevention Therapy plus placebo
Behavioral: Relapse Prevention Therapy
Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.
Active Comparator: Sertraline and Relapse Prevention
Patients will be treated with Relapse Prevention Therapy plus Sertraline.
Behavioral: Relapse Prevention Therapy
Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.
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 Names:
  • zoloft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Carlos Blanco, M.D., Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2001

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

November 3, 2005

First Submitted That Met QC Criteria

November 3, 2005

First Posted (Estimate)

November 7, 2005

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #5156R
  • 5K23DA000482 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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