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Bupropion in the Treatment of Pathological Gambling

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ClinicalTrials.gov Identifier: NCT00055393
Recruitment Status : Completed
First Posted : March 3, 2003
Last Update Posted : March 14, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Donald Black, University of Iowa

Tracking Information
First Submitted Date  ICMJE February 28, 2003
First Posted Date  ICMJE March 3, 2003
Last Update Posted Date March 14, 2017
Study Start Date  ICMJE July 2002
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00055393 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bupropion in the Treatment of Pathological Gambling
Official Title  ICMJE Bupropion Versus Placebo in the Treatment of Pathological Gambling
Brief Summary This study will determine whether the drug bupropion is an effective treatment for Pathological Gambling.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pathological Gambling
Intervention  ICMJE
  • Drug: Bupropion
    18 subjects in this randomly controlled double blind study received bupropion.
  • Drug: Placebo
    21 subjects received Placebo.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Bupropion
  • Placebo Comparator: Subjects receiving Placebo
    The inactive arm subjects in this randomly controlled study (n = 21) received a placebo.
    Intervention: Drug: Placebo
Publications * Black DW, Arndt S, Coryell WH, Argo T, Forbush KT, Shaw MC, Perry P, Allen J. Bupropion in the treatment of pathological gambling: a randomized, double-blind, placebo-controlled, flexible-dose study. J Clin Psychopharmacol. 2007 Apr;27(2):143-50.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
80
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2006
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00055393
Other Study ID Numbers  ICMJE 200007038
R21MH063289 ( U.S. NIH Grant/Contract )
DSIR AT-AS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.
Responsible Party Donald Black, University of Iowa
Study Sponsor  ICMJE University of Iowa
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Donald W Black, MD University of Iowa
PRS Account University of Iowa
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP