Bupropion in the Treatment of Pathological Gambling | NCT00055393

Studies
Bupropion in the Treatment of Pathological Gambling

NCT00055393

Sponsor

University of Iowa

Status

Completed

Last Update Posted

Mar 14, 2017Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Pathological Gambling

Interventions

Bupropion
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R21MH063289	U.S. NIH Grant/Contract		View source
DSIR AT-AS

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2002

Primary Completion Date

May 2005Actual

Completion Date

Apr 2006Actual

First Submitted Date

Feb 28, 2003

First Submission Date that Met QC Criteria

Feb 28, 2003

First Posted Date

Mar 3, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2017

Last Update Posted Date

Mar 14, 2017Actual

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupropion	Drug	18 subjects in this randomly controlled double blind study received bupropion.	Subjects receivng Bupropion

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Donald W Black, MD	University of Iowa	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Roy J. and Lucille A. Carver College of Medicine, University of Iowa		Iowa City	Iowa	52242	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17414236	Result	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. doi: 10.1097/01.jcp.0000264985.25109.25.

ID	Term
D012309	Risk-Taking
D001519	Behavior
D007174	Disruptive, Impulse Control, and Conduct Disorders
D001523	Mental Disorders

ID	Term
D011427	Propiophenones
D007659	Ketones
D009930	Organic Chemicals