Bupropion in the Treatment of Pathological Gambling

• ClinicalTrials.gov Identifier: NCT00055393
• Recruitment Status: Completed
• First Posted: March 3, 2003
• Last Update Posted: March 14, 2017
• Sponsor: University of Iowa
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Donald Black, University of Iowa

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pathological Gambling	Drug: Bupropion; Drug: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Bupropion Versus Placebo in the Treatment of Pathological Gambling
• Study Start Date: July 2002
• Actual Primary Completion Date: May 2005
• Actual Study Completion Date: April 2006

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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 of Results:

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
• First Posted: March 3, 2003
• Last Update Posted: March 14, 2017
• Last Verified: March 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