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

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00249431
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 9
• Arms: 2
• Actual Duration (Months): 48

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholism; Gambling	Drug: Sertraline; Behavioral: Relapse Prevention Therapy	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Sertraline Plus Relapse Prevention Therapy (RP) for the Treatment of Pathological Gambling With Comorbid Abuse or Dependence
• Actual Study Start Date: Dec 1, 2001
• Actual Primary Completion Date: Dec 1, 2005
• Actual Study Completion Date: Dec 1, 2005

Arms and Interventions

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.	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 ; Behavioral: Relapse Prevention Therapy; Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.

Outcome Measures

Primary Outcome Measures

1. Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale. [10 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• New York State Psychiatric Institute
• National Institute on Drug Abuse (NIDA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00249431
• Other Study ID Numbers: #5156R; 5K23DA000482
• First Posted: Nov 7, 2005
• Last Update Posted: Oct 27, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by New York State Psychiatric Institute: Gambling; Alcohol
• Additional relevant MeSH terms: Alcoholism; Gambling; Sertraline

Study Results

No Results Posted as of Oct 27, 2017