Expired Study
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Iowa City, Iowa 52242


Purpose:

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


Study summary:

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.


Criteria:

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).


Study is Available At:


Original ID:

200007038


NCT ID:

NCT00055393


Secondary ID:

R21MH063289


Study Acronym:


Brief Title:

Bupropion in the Treatment of Pathological Gambling


Official Title:

Bupropion Versus Placebo in the Treatment of Pathological Gambling


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Iowa


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

80


Enrollment Type:

Actual


Overall Contact Information

Official Name:Donald W Black, MD
Principal Investigator
University of Iowa

Study Dates

Start Date:July 2002
Completion Date:April 2006
Completion Type:Actual
Primary Completion Date:May 2005
Primary Completion Type:Actual
Verification Date:March 2017
Last Changed Date:March 10, 2017
First Received Date:February 28, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Bupropion
Description:18 subjects in this randomly controlled double blind study received bupropion.
Arm Name:Subjects receivng Bupropion
Intervention Type:Drug
Name:Placebo
Description:21 subjects received Placebo.
Arm Name:Subjects receiving Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Subjects receiving Placebo
Description:The inactive arm subjects in this randomly controlled study (n = 21) received a placebo.
Study Arm Type:Active Comparator
Arm Name:Subjects receivng Bupropion
Description:The active arm subjects in this study (n = 18) received flexibly dosed bupropion in this randomized 12-week double-blind trial.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Iowa
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:17414236

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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