Bupropion in the Treatment of Pathological Gambling

This study has been completed.

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Donald Black, University of Iowa

ClinicalTrials.gov Identifier:

NCT00055393

First received: February 28, 2003

Last updated: March 10, 2017

Last verified: March 2017

History of Changes

Purpose

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

Condition	Intervention
Pathological Gambling	Drug: Bupropion Drug: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Bupropion Versus Placebo in the Treatment of Pathological Gambling

Resource links provided by NLM:

MedlinePlus related topics: Compulsive Gambling

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by Donald Black, University of Iowa:


Enrollment:	80
Study Start Date:	July 2002
Study Completion Date:	April 2006
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: Bupropion 18 subjects in this randomly controlled double blind study received bupropion.
Placebo Comparator: Subjects receiving Placebo The inactive arm subjects in this randomly controlled study (n = 21) received a placebo.	Drug: Placebo 21 subjects received Placebo.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055393

Locations


United States, Iowa
Roy J. and Lucille A. Carver College of Medicine, University of Iowa
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

University of Iowa

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Donald W Black, MD	University of Iowa

More Information

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.


Responsible Party:	Donald Black, Professor of and MD in Psychiatry, University of Iowa
ClinicalTrials.gov Identifier:	NCT00055393 History of Changes
Other Study ID Numbers:	200007038 R21MH063289 ( U.S. NIH Grant/Contract ) DSIR AT-AS
Study First Received:	February 28, 2003
Last Updated:	March 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	There is no plan to share individual participant data.


Studies a U.S. FDA-regulated Drug Product:		No

Additional relevant MeSH terms:


Gambling Disruptive, Impulse Control, and Conduct Disorders Mental Disorders Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors	Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 21, 2017

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