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

Condition(s) targeted: Alcoholism; Gambling

Intervention: Sertraline (Drug); Relapse Prevention Therapy (Behavioral)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Carlos Blanco, M.D., Principal Investigator, Affiliation: Columbia University

Overall contact:
Mayumi Okuda, Phone: (212)543-5132, Email: okudama@nyspi.cpmc.columbia.edu

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.

Official title: A Pilot Study of Sertraline Plus Relapse Prevention Therapy (RP) for the Treatment of Pathological Gambling With Comorbid Abuse or Dependence

Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale.

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Mayumi Okuda, Phone: (212)543-5132, Email: okudama@nyspi.cpmc.columbia.edu

New York State Psychiatric Institute/Columbia University-2, New York, New York 10032, United States; Recruiting
Mayumi Okuda, Phone: 212-543-5132, Email: okudama@nyspi.cpmc.columbia.edu

Starting date: December 2001
Ending date: December 2010
Last updated: September 10, 2009