Bupropion in the Treatment of Pathological Gambling

Bupropion Versus Placebo in the Treatment of Pathological Gambling

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

Study Overview

• Status: Completed
• Conditions: Pathological Gambling
• Intervention / Treatment: Drug: Bupropion; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Donald W Black, MD, University of Iowa

Publications and helpful links

General 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. doi: 10.1097/01.jcp.0000264985.25109.25.

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: February 28, 2003
• First Submitted That Met QC Criteria: February 28, 2003
• First Posted (Estimate): March 3, 2003

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 10, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Gambling; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: 200007038; DSIR AT-AS; R21MH063289 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No