NCT00055393

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2003

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

February 28, 2003

Last Update Submit

March 10, 2017

Conditions

Pathological Gambling

Study Arms (2)

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

BupropionDRUG

18 subjects in this randomly controlled double blind study received bupropion.

Subjects receivng Bupropion
PlaceboDRUG

21 subjects received Placebo.

Subjects receiving Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

  • 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.

    PMID: 17414236RESULT

MeSH Terms

Conditions

Gambling

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Donald W Black, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of and MD in Psychiatry

Study Record Dates

First Submitted

February 28, 2003

First Posted

March 3, 2003

Study Start

July 1, 2002

Primary Completion

May 1, 2005

Study Completion

April 1, 2006

Last Updated

March 14, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data.

Locations

US(1)