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Bupropion in the Treatment of Pathological Gambling

Sponsor
University of Iowa (Other)
Overall Status
Completed
CT.gov ID
NCT00055393
Collaborator
National Institute of Mental Health (NIMH) (NIH)
80
Enrollment
1
Location
2
Arms
45
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will determine whether the drug bupropion is an effective treatment for Pathological Gambling.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

As gambling opportunities proliferate, PG has become a major health concern. Despite its importance, few treatment options with proven efficacy exist. This study will attempt to identify an effective treatment for PG.

Participants are randomly assigned to receive either bupropion or placebo for 12 weeks. Participants are assessed at baseline and at Weeks 2, 3, 4, 5, 6, 8, 10, and 12. Self administered questionnaires and interviews are used to assess participants. Follow-up assessments are made 1, 3, and 6 months after study completion.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Bupropion Versus Placebo in the Treatment of Pathological Gambling
Study Start Date :
Jul 1, 2002
Actual Primary Completion Date :
May 1, 2005
Actual Study Completion Date :
Apr 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Subjects receivng Bupropion

The active arm subjects in this study (n = 18) received flexibly dosed bupropion in this randomized 12-week double-blind trial.

Drug: Bupropion
18 subjects in this randomly controlled double blind study received bupropion.
Placebo Comparator: Subjects receiving Placebo

The inactive arm subjects in this randomly controlled study (n = 21) received a placebo.

Drug: Placebo
21 subjects received Placebo.

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Meet the criteria for Pathological Gambling (DSM-IV-TR), through the administration of the National Opinion Research Center DSM Screen for Gambling Problems(NODS);

    • Meet the criteria for Pathological Gambling (DSM-IV-TR), through the administration of the National Opinion Research Center DSM Screen for Gambling Problems(NODS);

    • Receive a score of 5 or more on the South Oaks Gambling Screen (SOGS);

    • Have PG for at least one year;

    • Have had at least 2 or more gambling episodes during the 2-week screening period;

    • Speak standard English;

    • Be able to give written informed consent.

    Exclusion Criteria:

    • Evidence of current (past 3 months) substance misuse;

    • Had a Hamilton Depression Rating Scale (HDRS)27 score of 18 or more (or a score on item 1 of greater than 2;

    • Had a current eating disorder (except binge eating disorder);

    • Had any history of seizures, or suicidal or aggressive behavior;

    • Had a urine drug screen positive for stimulants, opiates, hallucinogens, or phencyclidine;

    • Had a current or past psychotic disorder, bipolar disorder, or significant cognitive disorder;

    • Received monoamine oxidase inhibitors within 3 weeks of randomization, long acting phenothiazine within 3 months of randomization,fluoxetine within 4 weeks of randomization, or other psychotropic drugs within 2 weeks of randomization;

    • Had prior exposure to bupropion;

    • Were engaged in individual, group, or couples psychotherapy during the 2 weeks before randomization, (except Gamblers Anonymous).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roy J. and Lucille A. Carver College of Medicine, University of Iowa Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • University of Iowa
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Donald W Black, MD, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Donald Black, Professor of and MD in Psychiatry, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT00055393
    Other Study ID Numbers:
    • 200007038
    • R21MH063289
    • DSIR AT-AS
    First Posted:
    Mar 3, 2003
    Last Update Posted:
    Mar 14, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Additional relevant MeSH terms:
    Gambling
    Bupropion

    Study Results

    No Results Posted as of Mar 14, 2017