NCT00249431

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2001

Typical duration for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

4 years

First QC Date

November 3, 2005

Last Update Submit

October 26, 2017

Conditions

AlcoholismGambling

Keywords

GamblingAlcohol

Outcome Measures

Primary Outcomes (1)

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

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

    10 weeks

Study Arms (2)

Placebo and Relapse Prevention

PLACEBO COMPARATOR

Patients will be treated with Relapse Prevention Therapy plus placebo

Behavioral: Relapse Prevention Therapy

Sertraline and Relapse Prevention

ACTIVE COMPARATOR

Patients will be treated with Relapse Prevention Therapy plus Sertraline.

Drug: SertralineBehavioral: Relapse Prevention Therapy

Interventions

SertralineDRUG

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

Also known as: zoloft
Sertraline and Relapse Prevention
Relapse Prevention TherapyBEHAVIORAL

Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.

Placebo and Relapse PreventionSertraline and Relapse Prevention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets DSM-IV criteria for pathological gambling
  • Meets DSM-IV and SCID criteria for alcohol abuse or dependence
  • Medically healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.

    PMID: 36130734DERIVED

MeSH Terms

Conditions

AlcoholismGambling

Interventions

SertralineSecondary Prevention

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersRisk-TakingBehaviorDisruptive, Impulse Control, and Conduct Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsTherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Carlos Blanco, M.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

December 1, 2001

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

October 27, 2017

Record last verified: 2017-10