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Bupropion in the Treatment of Pathological Gambling

Primary Purpose

Pathological Gambling

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupropion
Placebo
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pathological Gambling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Roy J. and Lucille A. Carver College of Medicine, University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Subjects receivng Bupropion

Subjects receiving Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 28, 2003
Last Updated
March 10, 2017
Sponsor
University of Iowa
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00055393
Brief Title
Bupropion in the Treatment of Pathological Gambling
Official Title
Bupropion Versus Placebo in the Treatment of Pathological Gambling
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald W Black, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roy J. and Lucille A. Carver College of Medicine, University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data.
Citations:
PubMed Identifier
17414236
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. doi: 10.1097/01.jcp.0000264985.25109.25.
Results Reference
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Bupropion in the Treatment of Pathological Gambling

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